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Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: Randomised controlled trial

Authors:
  • my mhealth limited
  • Southampton City Primary Care
  • Portsmouth Hospitals University NHS Trust and Isle of Wight NHS Trust

Abstract

Objective To obtain evidence whether the online pulmonary rehabilitation(PR) programme ‘my-PR’ is non-inferior to a conventional face-to-face PR in improving physical performance and symptom scores in patients with COPD. Design A two-arm parallel single-blind, randomised controlled trial. Setting The online arm carried out pulmonary rehabilitation in their own homes and the face to face arm in a local rehabilitation facility. Participants 90 patients with a diagnosis of chronic obstructive pulmonary disease (COPD), modified Medical Research Council score of 2 or greater referred for pulmonary rehabilitation (PR), randomised in a 2:1 ratio to online (n=64) or face-to-face PR (n=26). Participants unable to use an internet-enabled device at home were excluded. Main outcome measures Coprimary outcomes were 6 min walk distance test and the COPD assessment test (CAT) score at completion of the programme. Interventions A 6-week PR programme organised either as group sessions in a local rehabilitation facility, or online PR via log in and access to 'myPR’. Results The adjusted mean difference for the 6 min walk test (6MWT) between groups for the intention-to-treat (ITT) population was 23.8 m with the lower 95% CI well above the non-inferiority threshold of −40.5 m at −4.5 m with an upper 95% CI of +52.2 m. This result was consistent in the per-protocol (PP) population with a mean adjusted difference of 15 m (−13.7 to 43.8). The CAT score difference in the ITT was −1.0 in favour of the online intervention with the upper 95% CI well below the non-inferiority threshold of 1.8 at 0.86 and the lower 95% CI of −2.9. The PP analysis was consistent with the ITT. Conclusion PR is an evidenced-based and guideline-mandated intervention for patients with COPD with functional limitation. A 6-week programme of online-supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of effects on 6MWT distance, and symptom scores and was safe and well tolerated.
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BourneS, etal. BMJ Open 2017;7:e014580. doi:10.1136/bmjopen-2016-014580
Open Access
AbstrAct
Objective To obtain evidence whether the online pulmonary
rehabilitation(PR) programme ‘my-PR’ is non-inferior to
a conventional face-to-face PR in improving physical
performance and symptom scores in patients with COPD.
Design A two-arm parallel single-blind, randomised
controlled trial.
Setting The online arm carried out pulmonary
rehabilitation in their own homes and the face to face arm
in a local rehabilitation facility.
Participants 90 patients with a diagnosis of chronic
obstructive pulmonary disease (COPD), modied Medical
Research Council score of 2 or greater referred for pulmonary
rehabilitation (PR), randomised in a 2:1 ratio to online (n=64)
or face-to-face PR (n=26). Participants unable to use an
internet-enabled device at home were excluded.
Main outcome measures Coprimary outcomes were
6 min walk distance test and the COPD assessment test
(CAT) score at completion of the programme.
Interventions A 6-week PR programme organised either
as group sessions in a local rehabilitation facility, or online
PR via log in and access to 'myPR’.
Results The adjusted mean difference for the 6 min walk
test (6MWT) between groups for the intention-to-treat (ITT)
population was 23.8 m with the lower 95% CI well above
the non-inferiority threshold of −40.5 m at −4.5 m with an
upper 95% CI of +52.2 m. This result was consistent in the
per-protocol (PP) population with a mean adjusted difference
of 15 m (−13.7 to 43.8). The CAT score difference in the ITT
was −1.0 in favour of the online intervention with the upper
95% CI well below the non-inferiority threshold of 1.8 at 0.86
and the lower 95% CI of −2.9. The PP analysis was consistent
with the ITT.
Conclusion PR is an evidenced-based and guideline-
mandated intervention for patients with COPD with
functional limitation. A 6-week programme of online-
supported PR was non-inferior to a conventional model
delivered in face-to-face sessions in terms of effects on
6MWT distance, and symptom scores and was safe and
well tolerated.
INTRODUCTION
Chronic obstructive pulmonary disease
(COPD) is a highly prevalent condi-
tion, which results in gradual loss of lung
function, increasing symptoms and func-
tional limitation over time.1 Pulmonary
rehabilitation (PR) is a non-pharmacolog-
ical intervention at the core of management
of COPD, aimed at reducing the burden
of symptoms by increasing exercise toler-
ance and improving self-management.
With an established evidence-base, PR has
been placed at the centre of interventions
for COPD and its provision is mandated
by the National Institute for Health and
Care Excellence (NICE) as a key pillar of
integrated care.1 The model of care for
providing PR is traditionally a face-to-face,
structured programme of exercise training
and education completed in a supervised,
centre-based setting over an established
protocol of a minimum of 6 weeks.2
While PR has been shown to improve func-
tional performance and physical activity3
and greater activity levels have themselves
been associated with reduced risk of hospi-
talisation,4 access to programmes can be
problematic for some patients and the
impact of conventional PR is limited by
Online versus face-to-face pulmonary
rehabilitation for patients with chronic
obstructive pulmonary disease:
randomised controlled trial
Simon Bourne,1,2 Ruth DeVos,1,2 Malcolm North,2 Anoop Chauhan,1 Ben Green,1
Thomas Brown,1 Victoria Cornelius,3 Tom Wilkinson2,4
To cite: BourneS, DeVosR,
NorthM, etal. Online versus
face-to-face pulmonary
rehabilitation for patients
with chronic obstructive
pulmonary disease: randomised
controlled trial. BMJ Open
2017;7:e014580. doi:10.1136/
bmjopen-2016-014580
Prepublication history and
additional material are available.
To view these les, please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2016-
014580).
Received 4 October 2016
Revised 10 May 2017
Accepted 18 May 2017
1Portsmouth Hospitals NHS
Trust, Portsmouth, UK
2myMHealth Ltd Bournemouth,
UK
3Imperial College, London, UK
4Clinical and Experimental
Sciences, Faculty of Medicine,
University of Southampton,
Southampton, UK
Correspondence to
Dr Tom Wilkinson; t. wilkinson@
soton. ac. uk
Research
Strengths and limitations of this study
This study explored the efcacy and safety ‘myPR’, a
novel method for delivering pulmonary rehabilitation
by online support compared with conventional face-
to-face delivery in classes using a randomised
controlled trial to explore whether the online
programme was non-inferior to the standard model.
Due to the nature of the intervention, only patients
with access to the internet at home could be
included in the study.
Further limitations of this study include the limited
sample size,and the absence of long-term follow-
up. Larger studies are required to explore the health-
economic benets of this model and applicability in
different healthcare settings.
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Open Access
suboptimal attendance and high dropout rates.5 6 With
an ever-increasing burden on services, conventional
models of care are constantly being challenged and
alternative, cost-effective ways of delivering healthcare
to a larger cohort of patients are being sought. Indeed,
the key message and goal in the recent American
Thoracic Society/European. Respiratory Society policy
statement of the implementation and delivery of PR is
‘to expand provision of PR to suitable patients world-
wide'.7
Patients with COPD are encouraged to carry out PR
exercises in their home environment, and even unsu-
pervised exercise has been shown to be an effective
way of increasing exercise tolerance.8 More recently,
the use of Telehealth has been trialled as an alterna-
tive, and innovative way of delivering PR to individuals
in their home, with aims to increase its uptake and, in
particular access for those in isolated areas or who have
transport issues. This home-based intervention using
tele-monitoring equipment has shown some promise
in maintaining and further improving physical capacity
but hardware-related costs are high.9 10 In 2015, 86%
of patients with chronic cardiopulmonary disease had
internet access,11 and with this ever-increasing pres-
ence of technology in homes, online PR is beginning to
emerge as an alternative way of delivering PR.12 Indeed,
the current British Thoracic Society (BTS) PR guide-
lines2 recognise that ‘technology has the potential to be
used as an adjunct to rehabilitation or even provide a
"rehabilitative" service’.
Although aspects of PR have been delivered in the
home setting, the documented attempts have, to date,
lacked the capability of administering a comprehen-
sive programme provided by conventional face-to-face
PR. The conventional model combines delivery of
educational component including information on the
condition, prescribed treatments and advice on exer-
cise and self-directed care, delivered alongside an
incremental exercise programme. The educational
component of PR is recognised by the BTS as ‘funda-
mentally integral to the format and success of the
programme’ and ‘the intention of the educational
element is to support the lifestyle and behavioural
change and assist self-management to promote self-ef-
ficacy'.2
In response to the recognised demand for alterna-
tive ways of delivering PR, a comprehensive, online
internet-based PR programme consisting of a 6-week
incremental exercise programme alongside education
sessions was developed for patients with COPD. This
online PR programme, known as myPR, was developed
by a multidisciplinary team of respiratory specialists and
is designed to mirror all of the components of a conven-
tional COPD PR programme.
We conducted a non-inferiority randomised controlled
clinical trial to compare efficacy and safety of PR
supported by the online application compared with a
face-to-face class-based PR programme.
METHODS
Study design
This was a prospective, parallel group, single-blind
randomised controlled trial conducted in a single centre
in the UK. Patients were recruited from a range of primary
and secondary care clinical settings consistent with the
route of referral for PR. The non-inferiority trial design
was to compare the clinical delivery of a 6-week online
PR programme (myPR) to the current clinical standard
of face-to-face PR programme delivered in a conventional
community setting, to patients with COPD. This study was
approved by the research ethics committee for Berkshire
B of the UK Health Research Authority (15/SC/0345).
The study was registered online as NCT02706613.
Patients were consulted and played an active role in the
development of mycopd—the online intervention plat-
form. Patients were involved in reviewing the design of
the study including the potential study burden on people
with COPD, the choice and format of patient-reported
outcome measures, the writing of the patient information
sheets and the consent form.
We randomised eligible patients with COPD using a
computerised block permutation randomise sequencer
in a ratio of 2:1 to either the online arm (myPR) or to
receive standard face-to-face PR. A 2:1 ratio was used to
reduce the number of subjects in the more costly face-
to-face arm while maintaining power. Randomisation was
stratified by severity of COPD (forced expiratory volume
in 1 s (FEV1)% predicted) to ensure equal distribution
in both arms and used an online system for concealed
allocation.
Outcomes were measured at baseline and within 1 week
of completion of either arm of the study. Due to the
nature of the intervention, blinding of participants was
not possible. Study staff carrying out the postintervention
assessments (outcome assessors) were blind to which arm
the patient had been randomised to.
Study population
Participants suitable for PR were recruited to the study
from Portsmouth Hospitals NHS Trust outpatient respi-
ratory clinics. All those participants wishing to participate
were issued with a Patient Invitation Letter and a Patient
Information Sheet. Inclusion criteria were a diagnosis of
COPD as defined by the NICE COPD guidelines with a
modified Medical Research Council (mMRC) dyspnoea
of grade 2 or greater, with access to the internet and the
ability to operate a web platform and aged 40 years or
greater. Exclusion criteria were an exacerbation requiring
additional antibiotics and/or steroids within 2 weeks prior
to screening; patients who had already undertaken a PR
programme within the last 6 months; patients who have
another respiratory disease as their main complaint other
than COPD; uncontrolled hypertension; unstable cardio-
vascular disease or significant desaturation that would
make PR exercise unsafe or prevent programme partici-
pation; patients who were unable to walk or whose ability
to walk safely and independently is significantly impaired
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due to non-respiratory-related conditions and/or cogni-
tive impairment; patients who are unable to read or use
an internet-enabled device or do not have access to the
internet at home and a ‘Timed Up and Go’ (TUG) test
>4 s. The TUG test was introduced as a way of assessing
safety of unsupervised exercise of patients completing the
PR programme in their homes, as it is a reliable and valid
test for quantifying functional mobility12 and has been
validated for use with COPD.13
Online PR (myPR)
After assessment, participants randomised to the online
arm were issued with unique login details to access myPR.
They were given basic instructions on the use of the
programme, in a brief 5–10 min introductory session face
to face with a member of the clinical research team. They
were instructed to access myPR at least twice and up to
five times a week. The initial start-up instructions on the
programme were designed to explain each step of myPR
to the patient, and further instructions were given as
they progressed. The physiotherapist leading the online
programme also delivered the face-to-face programmes
to ensure standardisation between the programmes.
Patients were advised to carry out exercises at a time that
was convenient to them and when they felt their energy
levels were at their best. No specific advice was given
regarding exercise modification as this is built into the
online programme itself.
The online programme is incremental in nature and
ran over 6 weeks and each week the length of each of
the 10 exercises increased by 30 s, starting from 60 s in
week 1, to 3½ min in week 6. The on-screen exercises
were designed to be carried out with the patient in real
time, with the patient following and keeping up with the
video-facilitated exercises. One minute of rest time was
given between each of the 10 exercises, with advice given
on Borg score measurement along with other tips on
managing breathlessness. During each of the 6 weeks of
exercise, patients were directed to watch three different
educational videos per week as education is a recognised
and important component of PR and helps promote
self-management. These educational sessions included
anatomy of the lungs, an explanation of COPD, manage-
ment of anxiety and depression, claiming benefits,
self-management, managing breathlessness, medications
and treatments, managing exacerbations of COPD,
sputum clearance using the Active Cycle of Breathing
Technique, nutrition, pacing, smoking cessation and
advice on travel with COPD. All of these educational
sessions are suggested in the current BTS PR guidelines,
and patients could access these videos as often as they
wished each week.
Contact details of the research team were provided so
that patients had a point of reference for any queries they
had regarding the technology or any health concerns.
Details of the online programme can be accessed via www.
mymhealth. com/ mycopd.
Face-to-face PR
Patients randomised to the conventional face-to-face PR
were given the dates and times of the next available PR
being run in a rehabilitation facility by a physiotherapist
and nurse on the research team. Patients attended two
supervised sessions for 6 weeks and were asked to carry
out exercises at home an additional three times per
week. The programme consisted of 10 exercise stations,
which were identical to the exercises carried out by the
patients using myPR. The 10 exercises included biceps
curls, squats, push ups against a wall, leg extensions in
a sitting position, upright row with weights, sit-to-stand,
arm swings with a stick, leg kicks to the side, arm punches
with weights and step-ups. Both the online and face-to-
face programmes also included warm up and cool down
sessions.
The same educational sessions as on myPR were then
delivered, but were presented and discussed orally rather
than in video format as in myPR, which offered patients
the opportunity to address questions.
Primary and secondary outcomes
The primary outcome measures were to compare best
performance 6 min walk distance (6MWD) test over a
30 m course on completion of the online and conven-
tional PR programmes using the 6 min walk test (6MWT)
performed according to national standards,2 and impact
on health status using the COPD assessment test (CAT)
score. Secondary outcome measures included the St
Georges Respiratory Questionnaire (SGRQ) to assess
respiratory quality of life, and the Hospital Anxiety and
Depression Scale (HADS) to assess anxiety and depres-
sion. Safety was assessed by the incidence of adverse
events (AEs) in each arm at study completion.
Adverse events
AEs were captured in the face-to-face group at the start
of each session (twice a week) during the 6-week inter-
vention and at final assessment. In the online arm, AEs
were captured during a weekly phone call to the partici-
pant from the study clinical team and at final assessment.
Causality and severity was assessed by the clinical study
team.
STATISTICAL ANALYSES
Sample size calculation
The size of the study was chosen with consideration to
provision of preliminary evidence for the non-inferiority
of online PR as compared with gold standard face-to-face
PR. As a result, the primary focus was to obtain an esti-
mate for the lower bound of the 95% CI for the 6MWD
test, and upper bound of the 90% CI for the CAT. In a
fully powered study, it is common that the non-inferiority
margin is set to be half the clinically important minimum
difference. As this is the first examination of the interven-
tion the non-inferiority margin was chosen to be less than
the minimum important clinical difference but not as
high as the commonly used criteria of half the difference.
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Figure 1 CONSORT diagram patient ow in study. COPD, chronic obstructive pulmonary disease; ITT, intention to treat; PR,
pulmonary rehabilitation.
From the published literature and practice guidelines
on the 6MWD test, 54 m was a widely accepted minimum
value of a meaningful increase in patient’s perception of
exercise performance.14 15 This level was originally used to
establish power and calculate the appropriate sample size.
Assuming no difference between intervention arms and a
SD of 100,17 we required 75 participants (2:1 ratio) to esti-
mate the lower 95% CI bound for the mean difference to
be no more than 40.5 m. Subsequent to the study design,
an update minimally clinically important difference of 30
m has been proposed and adopted.16 17 Consideration of
both cut-offs was undertaken in the analysis.
An accepted clinically important minimum difference
of the CAT score is estimated to be 1.8 with a SD of 6.4.20
Assuming no difference between intervention arms and a
SD of 6.4, we required 94 participants (2:1 ratio) to esti-
mate the upper 90% CI bound for the mean difference
to be no more than 1.8. We took the larger of these two
values (n=94: 63:32 per arm).
Randomisation
Participants were randomised using permuted blocks via
an online randomisation system hosted by myMHealth in
a ratio of 2:1 with more participants being randomised
to the online myPR arm. A concealed allocation was
performed. Randomisation was stratified by disease
severity defined by the global initiative for obstructive
lung disease (GOLD) classification of COPD severity.18
Blinding
To ensure the study team remained blind as to which arm
of the study each participant was on, they were divided
into two teams. One team was responsible for the assess-
ment and randomisation of participants onto the study
and the other team provided the after-intervention assess-
ment. A separate team member, who was not involved in
the prestudy or poststudy assessments, was not blinded,
to ensure availability to answer any questions participants
had throughout the study, and deal with any potential
adverse events. All subjects were asked in advance not to
discuss their PR programme during assessments.
Statistical methods
Statistical analysis was performed for both the inten-
tion-to-treat (ITT) population and per-protocol (PP)
population. ITT analysis included all participants in the
arms they were randomised to regardless of adherence to
either intervention. The frequency, patterns and predic-
tors of missing data were explored. Data at follow-up was
imputed regardless of the reason for missing. Multiple
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Table 1 Baseline characteristics of randomised patients by
intervention arm
Baseline variables
Face-to-face
PR (n=26)
Online PR
(n=64)
Age (years), mean (SD) 71.4 (8.6) 69.1 (7.9)
Gender (male), n (%) 18 (69) 41 (62)
Smoking, n (%)
Current smoker 6 (23) 9 (14)
Ex-smoker 20 (76.9) 55 (85.9)
COPD severity, n (%)
Mild 5 (19) 15 (23)
Moderate 13 (50) 26 (41)
Severe 7 (27) 17 (27)
Very severe 1 (4) 6 (9)
FEV1, mean (SD) 1.66 (0.67) 1.63 (0.71)
FEV1% predicted, mean (SD) 60.5 (20.1) 58.0 (23.6)
FVC, mean (SD) 2.97 (1.03) 3.03 (0.99)
FVC predicted, mean (SD) 83.2 (21.2) 88.4 (22.0)
COPD, chronic obstructive pulmonary disease; FEV1, forced
expiratory volume in 1 s; FVC, forced vital capacity; PR, pulmonary
rehabilitation.
Table 2 Comorbidities by intervention arm
Comorbidities
Face-to-face
n (%) Online n (%)
Hypertension 7 (26.9%) 23 (35.9%)
Cardiovascular disease 13 (50%) 22 (34.3%)
Cerebrovascular disease 1 (3.8%) 5 (7.8%)
Dermatological 0 7 (10.9%)
Diabetes and endocrine 6 (23.1%) 14 (21.9%)
Gastroenterological 5 (19.2%) 21 (32.8%)
Haematological 1 (3.8%) 1 (1.6%)
Neurological and psychiatric 3 (11.5%) 11 (17.2%)
History of malignancy 3 (11.5%) 4 (6.3%)
Musculoskeletal 7 (25.9%) 9 (14.1%)
Renal 2 (7.7%) 2 (3.1%)
Other respiratory 1 (3.8%) 3 (4.7%)
None 3 (11.5%) 4 (6.3%)
imputation was implemented based on chained equation
model and using age, gender, baseline scores and COPD
severity assuming unobserved measurements were missing
at random (100 datasets).19 Analyses were repeated for
participants with complete data only and compared with
analyses where missing data were imputed.
In the gold standard care arm, participants were
invited to two face-to-face sessions per week. In the
intervention arm, participants could access rehabilita-
tion programme as much as they wanted to per week,
although they were requested to access the programme
at least five times per week, on different days. The PP
analysis population was defined as participants who, on
average, took up the offer of at least one face-to-face
session per week or accessed the online programme at
least once per week.
Baseline characteristics were summarised by randomi-
sation group as means and SDs (continuous normally
distributed variables), medians and IQRs (non-normally
distributed variables) and frequencies and percentages
(categorical variables). The mean differences in the
outcomes between the intervention and control arms and
95% and 90% CIs were estimated using linear regression
adjusted for disease severity measured by FEV1% predicted
and baseline functional capacity (6MWT) as both factors
are measurable and may impact on the response to exer-
cise training. Residual analysis was performed to examine
model assumptions.
RESULTS
Recruitment and baseline characteristics
Overall, 143 subjects were screened for eligibility. The
trial ran from September 2015 to March 2016. Figure 1
shows the subject flow for screening, randomisation and
follow-up in the study. Table 1 illustrates the personal
characteristics and baseline measures for the randomised
90 patients. No important imbalances were identified for
these variables between the two intervention groups. The
90 participants with COPD had a mean age of 70 years
(8.2) and moderate airflow obstruction with a mean
FEV1% predicted of 59% (22). Patients in intervention
arms were well matched prior to rehabilitation. Comor-
bidities for each intervention arm are illustrated in
table 2.
Primary outcomes
The baseline 6MWT distance was 416.5 (118.3) m in the
face-to-face group and 388.7 (104.4) m in the online
intervention group and rose to 445.1 (124.9) and 433.6
(102.9) m, respectively after the intervention.
The adjusted mean difference for the 6MWT between
groups for the ITT population was 23.8 m with the lower
95% CI well above the non-inferiority threshold of −40.5
m at −4.5 m with an upper 95% CI of +52.2 m. This result
was consistent in the PP population with a mean adjusted
difference of 15 m (−13.7 to 43.8). Non-inferiority of
intervention was seen whether the minimally clinically
important difference (MCID) of 54 or 30 m was used (see
figure 2A).
The CAT score difference in the ITT was −1.0 in favour
of the online intervention with the upper 95% CI well
below the non-inferiority threshold of 1.8 at 0.86 and a
lower 95% CI of −0.2.9. The PP analysis was consistent
with the ITT with a mean CAT score difference of −0.64
(95% CI −2.5 to 1.2) (figure 2B).
Secondary outcomes
HADS recorded at baseline demonstrated a reduction
indicative of improvement in both intervention arms. The
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Figure 2A Adjusted mean difference and 95% CI for 6 min walk test (6MWT) in the intention-to-treat (ITT) and per-protocol
(PP) population.
Figure 2B Adjusted mean difference and 95% CI for COPD assessment test (CAT) score in the intention-to-treat (ITT) and per-
protocol (PP) population.
adjusted mean difference for HADS for the ITT popula-
tion was −0.74 (95% CI −3.5 to 0.9) in favour of online
PR. Similarly, COPD health-related quality of life (SGRQ)
scores and mMRC dyspnoea scores suggested non-inferi-
ority for the online intervention group (see table 3).
PP analysis
Fifteen (23%) participants withdrew or were lost to
follow-up from the online group and 5 (19%) in the
face-to-face treatment groups. A breakdown of the
non-completer participants is summarised in the online
supplementary Table S1. A further three participants had
an exacerbation in the online group and were unable to
complete the final study assessments. A PP analysis of all
outcome measures recorded demonstrated differences
well outside the clinically important difference for infe-
riority for all stipulated MCID values. All intervention
effect estimates were in the direction of favour for the
online intervention (see table 4).
Safety
Adverse events are summarised in table 5. Overall, both
interventions were well tolerated with no safety issues
identified.
Adherence to rehabilitation training and education
Adherence in both study arms was incomplete. Table 6
summarises the exercise sessions completed: a) atten-
dance at the face-to-face group and b) participation
with the online sessions. Overall, 72% of the two face-
to-face sessions were attended, compared with 62% of
the suggested five sessions recorded as accessed online
over the 6-week intervention period. The attendance at
the face-to-face sessions was relatively stable with a mean
1.6 sessions per participant in week 1 and 1.4 in week 6,
while there was a decline in participation in the online
arm from a mean of 3.9 sessions per participant in week
1 to 2.5 in week 6.
DISCUSSION
We report a single-blinded, randomised clinical trial of
a novel and newly designed online pulmonary rehabili-
tation programme compared with the usual standard
of care PR, delivered by face-to-face supervised patient
sessions. The trial was designed to provide preliminary
evidence for the use of online PR by examining the
performance with respect to non-inferiority on validated
clinical measures namely the 6MWT and the CAT score.
The results are supportive of the hypothesis that there
is no difference in either coprimary outcomes between
these two approaches to delivering PR. In addition,
non-inferiority was demonstrated between the impacts of
online and conventional PR on validated clinical scores
for breathlessness or health-related quality of life between
the groups after the 6-week intervention period.
A predetermined PP analysis confirmed that for
compliers the online PR was non-inferior with a direction
of estimate in favour of online PR for all measures.
Clinical improvements with pulmonary rehabilitation and
comparison with other studies
Pulmonary rehabilitation is part of standard care for
patients with COPD who are functionally limited.1 2 It has
been demonstrated to improve exercise tolerance and
functional independence.3 The majority of studies of PR
in COPD have demonstrated benefits through delivery
of the model of a complex intervention of graded exer-
cise and education over a 6-week course, which has now
formed part of guideline-based treatment.2 The impact
of conventional PR on key outcomes such as 6MWD test
and CAT score has been assessed by a number of groups.
In a meta-analysis of 14 studies which measured changes
in the 6MWD test, the beneficial impact of PR was 55.7 m
(27.8–92.8),20 with an MCID modelled at an improvement
of 54 m for a patient to detect a benefit.14 Subsequent
studies have identified 30 m as an appropriate value.16 17
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Table 3 Between-group differences in primary and secondary outcomes
Mean value (SD), n
Regression
analysis(ITT
population)
Regression
analysis(PP
population)
Face-to-face PR
(n=26) Online PR (n=64)
Adjusted difference
(95% CI) p Value
Adjusted difference
(95% CI) p Value
6 min walk test (m)
Baseline 416.5 (118.3) 388.7 (104.4) 23.8 (−4.5 to 52.2) 0.098 15.0 (−13.7 to 43.8) 0.300
7 weeks 445.1 (124.9) 433.6 (102.9)
COPD assessment test score
Baseline 17.3 (6.7) 18.1 (7.9) −1.0 (−2.9 to 0.86) 0.373 −0.64 (−2.5 to 1.2) 0.569
7 weeks 16.2 (6.7) 14.9 (7.0)
Hospital Anxiety and Depression Scale
Baseline 10.0 (6.0–18.0) 10.0 (6.0–16.5) −0.74 (−3.5 to 0.9) 0.263 −1.2 (−3.5 to 1.2) 0.320
7 weeks 10.5 (5.0–13.0) 7.0 (4.0–15.0)
St Georges Respiratory Questionnaire
Baseline 37.7 (17.2) 42.4 (18.6) −3.72 (−10.7 to 3.3) 0.291 −2.5 (−9.3 to 4.4) 0.474
7 weeks 39.3 (18.5) 39.3 (18.5)
Modied Medical Research Council Dyspnoea score
Baseline 2.0 (1.0–2.0) 2.0 (1.0–3.0) 0.03 (−0.56 to 0.63) 0.909 0.04 (−0.54 to 0.63) 0.885
7 weeks 1.5 (1.0, 2.0) 1.0 (1.0, 2.0)
ITT, intention to treat; PP, per -protocol; PR, pulmonary rehabilitation.
Table 4 Number of participants with missing outcome data and summary by intervention arm for completers only
Mean value (SD), n
Face-to-face PR Online PR Regression p Value Direction of estimate
6 min walk test
Baseline 416.5 (118.3), 26 388.7 (104.4), 62 26.1 (−1.0 to 53.2) 0.06 In favour of online PR
7 weeks 457.3 (122.1), 21 449.4 (99.0), 46
COPD assessment test score
Baseline 17.3 (6.7), 26 18.1 (7.9), 64 −1.2 (−3.4 to 0.9) 0.260 In favour of online PR
7 weeks 15.2 (6.9), 21 15.2 (7.6), 44
Hospital Anxiety and Depression Scale
BaselineII 10.0 (6.0–18.0), 26 10.0 (6.0–16.5), 64 −1.2 (−3.3 to 1.0) 0.267 In favour of online PR
7 weeks 10.0 (4.5–12.5), 20 6.5 (4.0–14.5), 44
St Georges Respiratory Questionnaire
Baseline 37.7 (17.2), 26 42.4 (18.6), 64 −4.2 (−10.9 to 2.5) 0.215 In favour of online PR
7 weeks 38.1 (15.5), 21 39.3 (19.9), 44
Modied Medical Research Council Dyspnoea score
Baseline 2.0 (1.0–2.0), 26 2.0 (1.0–3.0), 64 −0.03 (−0.55 to 0.49) 0.912 In favour of online PR
7 weeks 1.0 (1.0, 2.0), 21 1.0 (1.0–2.0), 44
PR, pulmonary rehabilitation
The improvements in exercise capacity seen in this study
in both treatment arms were within range of those in
published analysis, demonstrated non-inferiority with
both MCID values and were similar to small studies in
comparable clinical groups.21
While the evidence for safety and benefit of PR for
patients with stable COPD is well established, the evidence
behind the best methods to deliver this intervention is
much less strong. The optimal duration of intervention
has been established by clinical studies comparing length
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Table 5 Intervention emergent adverse events by treatment
groups
Adverse event
Face-to-face
PR, n
Online
PR, n
Back pain 1 1
Muscular skeletal chest pain 0 1
Inguinal pain 1 0
Common cold 1 0
PR, pulmonary rehabilitation
Table 6 Exercise sessions completed by face-to-face (n=26) and online groups (n=64)
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
Face-to-face(n=26)
0 sessions 3 (11) 8 (31) 5 (19) 6 (23) 6 (23) 7 (27)
One session 3 (11) 3 (11) 4 (15) 1 (4) 5 (19) 1 (4)
Two sessions 20 (77) 15 (58) 17 (65) 19 (73) 15 (58) 18 (69)
Mean 1.6 1.3 1.5 1.5 1.3 1.4
online groups (n=64)
0 sessions 9 (14) 12 (19) 13 (20) 14 (22) 18 (28) 18 (28)
One session 2 (3) 2 (3) 4 (6) 6 (9) 2 (3) 4 (6)
Two sessions 6 (9) 5 (8) 7 (11) 8 (13) 6 (9) 11 (17)
Three sessions 4 (6) 7 (11) 5 (8) 8 (13) 11 (17) 8 (13)
Four sessions 11 (17.2) 6 (9) 9 (14) 5 (8) 6 (9) 9 (14)
Five sessions 17 (27) 25 (39) 18 (28) 17 (27) 17 (27) 9 (14)
Six sessions 11 (17) 6 (9) 8 (13) 4 (6) 3 (5) 5 (8)
Seven sessions 4 (6) 1 (2) 0 (0) 2 (3) 1 (2) 0 (0)
Mean 3.9 3.5 3.2 3.0 2.8 2.5
All numbers are n (%)
of PR exposure,22 23 but the current design and delivery
of education and exercise interventions is based largely
on best practice and expert opinion.2 Indeed, the recent
BTS guidelines on P R highlight the need for funda-
mental research in this area: ‘The optimal structure of PR
remains unknown. More robust studies are required to
determine quality, cost-effectiveness and greater choice
of delivery. To improve accessibility to PR, such research
may include technologies’.
This study has established the potential for delivery
of PR via an online platform in demonstrating non-in-
feriority of all measured outcomes compared with
conventional PR.
Despite the widespread use of online technologies to
manage almost every aspect of daily life, there are surpris-
ingly few well-conducted clinical trials in this field. A
small pilot study explored the use of online PR in COPD
and found the intervention to hold possible merit with
improvements in quality of life and a favourable cost-ben-
efit model.24 Our approach supports this preliminary
finding and offers new evidence that online-supported
PR may benefit a range of patients with COPD who may
be able to access this important intervention through the
use of this technology for the first time.
Within the limitations of the sample size, our study
demonstrated that online PR demonstrated no significant
safety concerns and similarly to conventional PR appears
to be an appropriate intervention if careful clinical
measures are taken to mitigate risk.1 2 Significant numbers
of patients were excluded due to exercise-induced oxygen
desaturation. In face-to-face PR, supplemental oxygen
can be administered and saturations monitored so for
this subset of patients further work is required to ascer-
tain the suitability of online-supported models and best
practice therein.
Access and adherence—key issues for delivery of PR
Access to high-quality PR for patients with COPD is variable
in the UK.25 Resource limitations, geographical distance
from treatment centres and availability of classes which
suit time commitments for participants have all been cited
as key reasons why PR is currently ineffectively delivered
to a large proportion of patients who may benefit.25 This
national audit of PR services identified that over 37% of
patients wait over 3 months for access to classes. Working
patients are particularly disadvantaged as classes are often
only provided during office hours. Consequently, atten-
dance at PR is uniformly low and completion of courses
similarly suboptimal with only 69% of patients referred
attending for assessment. Capacity for delivery is currently
limited— the UK National Audit estimates that 81 000
referrals are made for PR each year—the great majority
for COPD. This is in comparison to the estimated 900 000
patients with an established diagnosis in the UK with a
significant number of patients having no access to local
services within a reasonable travelling time.2 25
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The majority of patients in high-income countries
have access to the internet—a recent study established
that over 86% of patients with cardiopulmonary disease
have direct access.11 Indeed, the majority of subjects (161
of 163) assessed for eligibility for the study had access
to the internet. Furthermore, study of regular internet
use in patients with long-term conditions has identified
that the majority with access (68%), use the internet
regularly to understand more about their disease.26
Currently, disease relevant information is often avail-
able from charities and patient group sites and users
seldom have access to prescribed interventions to date.
This situation will undoubtedly change rapidly in the UK
with the announcement that the National Health Service
(NHS) will support prescription of digital health tech-
nologies from April 2017. However, even with improving
patterns of internet access it is important that most if
not all patients can use digital platforms effectively and
with minimum requirements for training and support
The ‘myCOPD’ web app was designed with patients and
extensive usability assessments were carried out in the
development process. Inevitably, even with a user-friendly
system implementation to all patients with a chronic
condition will be challenging, further studies to define
optimal models to ensure equity of access are required
and resources to ensure support considered in health
economic assessments.
Adherence to PR is another barrier to its overall impact
in this patient group. In 1998, Singh et al found less than
half of patients referred to PR completed the course.27
Adherence rates reported in clinical trials such as this
tend to be higher and our completion rates of over 70%
for this trial are in line with these. There is minimal
published evidence regarding the factors that lead to
non-adherence to PR in patients with COPD. Young et
al identified a number of patient factors including social
isolation and active smoking which predicted poor adher-
ence to PR, suggesting that the necessity for patients to
participate in group sessions may be a barrier for certain
patients.28 In our study, adherence to the intervention in
both arms was as expected, incomplete. Although there
was an attrition over the 6-week intervention period to the
use of online PR, in terms of supported sessions accessed
each week, the mean was still greater than the face-to-
face arm. Very little additional support from the trial or
technical team was required in this study by patients in
the online arm, with most issues resolved remotely. It is
possible a more intensive online or telephone mentoring
approach may improve adherence yet further. We suggest
further studies are required to determine the patient’s
preference for the model of access to PR and the impacts
of this ‘patient-centred’ approach on access and adher-
ence.
Comparison with digital health interventions in other
disease areas
In other disease areas or aspects of COPD care,
there is a richer evidence base to support the role of
digitally supported interventions. In the management of
dyspnoea, a comparison of internet-based versus face-to-
face supported self- management in COPD was assessed
in a small randomised controlled trial.29 This study was
published over 8 years ago and was troubled by tech-
nical challenges; however, its findings demonstrated that
both online and face-to-face programmes were useful in
improving dyspnoea. Cardiac rehabilitation is another
evidence-based facet of the management of a long-term
condition. Patients with cardiac conditions demonstrate a
high level of interest in the concept of technology-enabled
home rehabilitation.30 Clinical studies of internet-based
interventions suggest clinical benefit for patients with
ischaemic heart disease, although overall conclusions
are limited by poor trial quality and the data to support
improvements in activity was stronger.31
The data from our study is aligned with the avail-
able data from existing trials across a range of diseases
suggesting that online supported management and reha-
bilitation may offer clinical benefits. Considering the
range of comorbidities that a large proportion of patients
with long-term conditions suffer from it is vital that a coor-
dinated approach to enable an overall improvement in
health rather than just single disease relevant outcomes is
the goal for the emerging use of mobile health technol-
ogies. This will require close working between clinicians,
technologists and commissioners to ensure that a coordi-
nated and patient friendly approach is developed along
with rigorous testing to establish clinical benefit and
cost-effectiveness.
Limitations of this study
We acknowledge a number of limitations to the interpre-
tation of this trial. It is a relatively small study, which was
designed to explore the non-inferiority of online PR inter-
vention. While we report that all clinical outcomes were
non- inferior, we accept that a larger randomised controlled
trial fully powered to demonstrate health economic benefits
is required to explore the potential to change the model of
PR delivery and hence clinical practice. The study was rela-
tively short—in line with the current clinical model of 6-week
to 12-week clinical PR courses. As extending the online
intervention is not limited by resource implications, it will
be possible to explore the role of long-term programmes
including maintenance classes and the duration of impacts
using this model. Our study was also delivered at a single
centre; we recognise practice may differ across providers
and regions and hence a multicentred pragmatic study is
indicated to understand the place for online PR in compli-
menting current practice in a range of clinical settings.
As with all studies of exercise-related interventions,
double blinding was not possible; however, this will have
impacted on both groups. Every effort was made to ensure
assessments were made in a blinded fashion in both arms.
As many of the barriers to delivery of face-to-face PR—
access, geography and capacity—are overcome within the
conduct of a randomised controlled trial, it is likely that the
real test of online technologies such as this will be against
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the usual standard of care and so ‘real-world’ data will be
key to explore the potential uptake and impacts in this situ-
ation. Therefore, further work is needed—not to establish
comparative efficacy of models but to establish a real-world
evidence base and to understand the long-term utility of
scalable digital platforms across healthcare settings.
Comparison with current guidelines
National and international guidelines recommend PR for
patients with COPD with functional limitation.1 2 Current
models for delivering PR are based on best practice
advice and rely on a model of face-to-face delivery, which
has been established over a number of years. Our study
was designed and delivered in this context and provides
important evidence that a new model of internet-enabled
delivery for this vital intervention may be considered by
clinicians.
Conclusions and policy implementations
COPD is a disease of global health importance with a
limited array of clinically proven interventions available
to clinicians or patients to improve outcomes, PR is one
of these interventions and has become part of the stan-
dard of care for this disease. Recent national audits have
identified significant inadequacies in accessing PR and
recent UK guidelines identify the need for novel studies
to explore new models of delivering PR to patients with
COPD to overcome this unmet need.
We have conducted a significant study to explore
non-inferiority of the role of internet-enabled PR to
improve clinical outcomes compared with the standard
model of clinical delivery. We have demonstrated for
the first time that in all clinical measures studied, online
PR using the myMHealth platform is non-inferior to
usual care and suggest that this modality of delivery be
explored widely in the delivery of this important inter-
vention in this common disease. There is now a potential
opportunity for the online provision of PR to compli-
ment currently available face-to-face services in order to
increase capacity, reduce costs and broaden availability to
socially or geographically isolated groups, which requires
exploration in future studies across wide populations to
establish optimal implementation of strategies and to
assess health economic benefits.
Acknowledgements We thank the clinical trials team at Queen Alexandra
Hospitals NHS trust and the staff of myMHealth. We are grateful to the patients who
contributed to the design and conduct of the study.
Contributors RDV, MN, SCB, VC and TW contributed to the study design. BG was
principal investigator. RDV, MN, BG, TB and AJC contributed to the study delivery.
VC analysed the data. All authors contributed to data interpretation and manuscript
preparation and reviewed the nal draft. TW is guarantor for the data.
Funding The study was funded by a Small Business Research Initiative (SBRI)
grant from NHS England.
Competing interests Dr Bourne reports grants and personal fees from myMHealth
(a medical software company) during the conduct of the study; other from
myMHealth, outside the submitted work. He is CEO, co-founder and part owner
of this company. Mrs De Vos reports personal fees from myMHealth, during the
conduct of the study; and is a partner in the rehabilitation facility that hosted some
of the clinical trial activity. Dr Green reports grants to Portsmouth Hospitals NHS
Trust from myMHealth, during the conduct of the study. Mr North has nothing to
disclose. Dr Cornelius reports personal fees from myMHealth, during the conduct of
the study. Professor Chauhan has nothing to disclose. Dr Brown reports grants from
myMHealth, during the conduct of the study. Professor Wilkinson reports grants and
personal fees from myMHealth during the conduct of the study. He is co-founder
and part owner of this company.
Patient consent Detail has been removed from this case description/these case
descriptions to ensure anonymity. The editors and reviewers have seen the detailed
information available and are satised that the information backs up the case the
authors are making.
Ethics approval This study was approved by the research ethics committee for
Berkshire B of the UK Health Research Authority (15/SC/0345).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All anonymised trial data are available on application to
the senior author.
Open Access This is an Open Access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited and the use is non-commercial. See: http:// creativecommons. org/
licenses/ by- nc/ 4. 0/
© Article author(s) (or their employer(s) unless otherwise stated in the text of the
article) 2017. All rights reserved. No commercial use is permitted unless otherwise
expressly granted.
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controlled trial
obstructive pulmonary disease: randomised
rehabilitation for patients with chronic
Online versus face-to-face pulmonary
Green, Thomas Brown, Victoria Cornelius and Tom Wilkinson
Simon Bourne, Ruth DeVos, Malcolm North, Anoop Chauhan, Ben
doi: 10.1136/bmjopen-2016-014580
2017 7: BMJ Open
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... The study characteristics are summarized in Table 2. The majority of these trials were conducted in Europe (n = 8) [19][20][21][22][23][24][25]27], one trial in North America [15], one trial in Australia [18], two trials in Asia [16,26] and one trial in Canada [17]. ...
... Two trials used Web-based applications [15,16], five trials used video conferencing [17][18][19][20][21], one trial used online sessions [22], and five trials used smart phone applications [23][24][25][26][27]. The digital technology used in the pulmonary rehabilitation programmes in these trials focused on different types of exercise (endurance, strengthening, aerobic, breathing, flexibility, stretching, and resistance). ...
... The study characteristics are summarized in Table 2. The majority of these trials were conducted in Europe (n = 8) [19][20][21][22][23][24][25]27], one trial in North America [15], one trial in Australia [18], two trials in Asia [16,26] and one trial in Canada [17]. CG: Usual medical management including optimal pharmacological intervention. ...
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Background and Objectives: Chronic Obstructive Pulmonary Disease (COPD) is the third most common cause of death globally. Pulmonary rehabilitation (PR) programmes are important to reduce COPD symptoms and improve the quality of life of people with COPD. Digital health interventions have recently been adopted in PR programmes, which allow people with COPD to participate in such programmes with low barriers. The aim of this study is to review and discuss the reported effects of digital health interventions on PR outcomes in people with COPD. Materials and Methods: To achieve the study goals, a systematic literature search was conducted using PubMed (MEDLINE), CINAHL, AMED, SPORTDiscus and the Physiotherapy Evidence Database. Randomised clinical trials (RCTs) were included if they met specified criteria. Two reviewers independently checked titles, abstracts, and performed full-text screening and data extraction. The quality assessment and risk of bias were performed in accordance with the PEDRO scale and Cochrane Risk of Bias tool 2, respectively. Results: Thirteen RCTs were included in this systematic review with 1525 participants with COPD. This systematic review showed the potential positive effect of digital health PR on the exercise capacity—measured by 6- and 12-min walking tests, pulmonary function, dyspnoea and health-related quality of life. There was no evidence for advantages of digital health PR in the improvement of anxiety, depression, and self-efficacy. Conclusions: Digital health PR is more effective than traditional PR in improving the pulmonary and physical outcomes for people with COPD, but there was no difference between the two PR programmes in improving the psychosocial outcomes. The certainty of the findings of this review is affected by the small number of included studies.
... Digital therapeutics (DTx) refers to advanced software medical devices that provide evidence-based therapeutic interventions to prevent, manage, and treat diseases or disorders in patients. Recent studies have compared the impact of digital therapy on PR in patients with COPD and demonstrated comparable outcomes regarding exercise capacity and quality of life as measured using the six-minute walk test (6MWT) [16,17]. ...
... They reported that a 6-week program of online-supported PR was noninferior to a conventional face-to-face session regarding effects on 6MWD and symptom scores. Moreover, it was safe and well-tolerated [16]. However, the online program did not provide the FITT framework for aerobic exercises recommended by the ACSM. ...
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Background: This study aimed to investigate the efficacy and safety of digital therapeutics (DTx), EASYBREATH, for pulmonary rehabilitation (PR) in patients with chronic respiratory diseases (CRDs). Materials and Methods: This prospective randomized controlled trial was conducted at multiple centers. Participants were randomly allocated 1:1 to the DTx group (DTxG), provided with DTx using EASYBREATH. The DTxG underwent an 8-week PR program with evaluations conducted at baseline, four weeks, and eight weeks. The control group (CG) underwent one PR session and was advised to exercise and undergo the same evaluation. The primary outcome was the change in six-minute walking distance (6MWD) over eight weeks, and secondary outcomes included changes in scores of Modified Medical Research Council (mMRC), chronic obstructive pulmonary disease assessment test (CAT), and St. George’s respiratory questionnaire (SGRQ). Results: The change in 6MWD after eight weeks demonstrated a significant difference between the DTxG and CG (57.68 m vs. 21.71 m, p = 0.0008). The change in mMRC scores (p = 0.0008), CAT scores (p < 0.0001), and total SGRQ scores (p = 0.0003) also showed a significant difference between the groups after eight weeks. Conclusions: EASYBREATH significantly improved exercise capacity, alleviated dyspnea, and enhanced the overall quality of life at eight weeks. EASYBREATH is a highly accessible, time-efficient, and effective treatment option for CRD with high compliance.
... [7] Face-to-face pulmonary rehabilitation is among the common methods of pulmonary rehabilitation, but it has some limitations such as being time-consuming and forgetting information, and it also leads to spending more time and money and interferes with daily life activities. [8] Among other methods of pulmonary rehabilitation are mobile applications, which are considered an effective tool for increasing adherence to physical activity and enabling people to attain the health information and guidance they need at any time. [9] Moreover, to reduce the spread of the coronavirus, remote rehabilitation strategies should be adopted as an alternative method to provide rehabilitation services at the community level. ...
... In this regard, the results of one study confirmed the positive effect of the virtual pulmonary rehabilitation program on the physical performance of patients with COPD as much as the face-to-face program. [8] However, the results of another study showed that face-to-face pulmonary rehabilitation program had a better effect on the physical activity of patients with COPD compared to virtual pulmonary rehabilitation. [27] The reason for this difference can be attributed to the physical presence in the treatment environment and encouraging the person to adhere to treatment by observing the patients in the same condition and also the absence of problems using the application. ...
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Background Pulmonary Rehabilitation (PR) is recommended as a standard, effective, and important treatment for COVID-19 survivors who remain symptomatic after the acute phase. Therefore, we aimed to compare the effect of mobile phone-based PR application with face-to-face PR on the quality of life, anxiety, depression, and daily life activities of COVID-19 survivors. Materials and Methods A quasi-experimental was conducted on 65 COVID-19 survivors during 2022. Convenient sampling was done based on the inclusion criteria. The intervention group (n = 31) received PR through a mobile phone application, and the control group (n = 34) received face-to-face PR. Data were collected before and after the intervention in both groups using a demographic information questionnaire, SF-12, the hospital anxiety and depression scale, and Barthel scale. For all tests, a maximum error of 5% was considered. Results The two studied groups had no statistically significant difference with respect to all the investigated variables at baseline (p > 0.05). After the intervention, the mean anxiety and depression score of the patients in the control group was significantly lower than the intervention group (t = −3.46, f = 63, p = 0.01). After our intervention, there was no statistically significant difference in the mean quality of life and daily life activity scores between the two groups (t = −0.68, f = 63, p > 0.05). Conclusions The application of PR does not show a statistically significant difference in terms of improving the quality of life and daily activities compared with the face-to-face method; we suggest that the PR application be used as a cost-effective method when face-to-face PR is not possible.
... Before starting the pulmonary rehabilitation program, patients should perform exercise to measure the training capacity of each patient. [21][22][23] However, we could either assess the sit-to-stand test 6 The association between the mMRC scale and SGRQ was also found significant in the study of Ekici et al. 16 We observed a reduction in CAT score by 14 12,19,20 Hansen et al reported that the reduction of CAT score was statistically significant in supervised pulmonary rehabilitation, though it did not exceed the minimal important difference (MID). 16 The MID for the CAT score is a reduction of 2 points. ...
Article
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Background: Chronic obstructive pulmonary disease (COPD) patients are at high risk for COVID-19 infection and severe pulmonary complications. Exercise-based pulmonary rehabilitation (PR) in outpatient settings is essential for COVID-19 survivors with COPD comorbidities, providing the most critical patient benefits, but it is challenging during the pandemic.Case: A sixty-four-year-old man with COPD since 2 years ago, a history of COVID-19 one month ago, and Pulmonary Tuberculosis since 1 year ago presented with chief complaints of tiredness, cough, and breathlessness after walking for more than 100 meters. We performed PR, including breathing retraining exercise, chest mobility exercise, active cycle breathing technique (ACBT), posture correction, and aerobic exercise with static ergo-cycle for 8 weeks.Discussion: After 8 weeks of PR, there was a 3% increase in the O2 saturation level from 94-95% room air to 98%, an increase of single breath counting test (SBCT) from 20 to 38 counts, improvement of peak cough flow from 100-110-100 to 420-435-425 L/minute, and peak flow meter from 140-150-145 to 380-400-400 L/minute. Before PR the patient could not perform the sit-to-stand test (STS) and a 6-minute walking test (6MWT), but after 8 weeks of PR, STS was 5 times in 30 seconds, and 6MWT maximum distance was 248 meters. COPD assessment test (CAT) score improved from 23 to 9, and the Modified Medical Research Council (mMRC) dyspnea scale improved from 3 to 2.Conclusion: Eight weeks of pulmonary rehabilitation showed benefits for the patient in reducing dyspnea and improving exercise tolerance and quality of life, especially in hospital-based settings.
... The emergence of newer models of pulmonary rehabilitation, such as home-based pulmonary rehabilitation (HBPR) [25][26][27][28], have offered complementary person-centred options (and patient choice) for services to improve access, uptake and completion [21]. The range of pulmonary rehabilitation models now available have led to innovations and adjuncts in pulmonary rehabilitation components including health behaviour change [21]. ...
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Background The variety of innovations to traditional centre-based pulmonary rehabilitation (CBPR), including different modes of delivery and adjuncts, are likely to lead to differential responses in physical activity, sedentary behaviour and sleep. Objectives To examine the relative effectiveness of different pulmonary rehabilitation-based interventions on physical activity, sedentary behaviour and sleep. Methods Randomised trials in chronic respiratory disease involving pulmonary rehabilitation-based interventions were systematically searched for. Network meta-analyses compared interventions for changes in physical activity, sedentary behaviour and sleep in COPD. Results 46 studies were included, and analyses were performed on most common outcomes: steps per day (k=24), time spent in moderate-to-vigorous physical activity (MVPA; k=12) and sedentary time (k=8). There were insufficient data on sleep outcomes (k=3). CBPR resulted in greater steps per day and MVPA and reduced sedentary time compared to usual care. CBPR+physical activity promotion resulted in greater increases in steps per day compared to both usual care and CBPR, with greater increases in MVPA and reductions in sedentary time compared to usual care, but not CBPR. Home-based pulmonary rehabilitation resulted in greater increases in steps per day and decreases in sedentary time compared to usual care. Compared to usual care, CBPR+physical activity promotion was the only intervention where the lower 95% confidence interval for steps per day surpassed the minimal important difference. No pulmonary rehabilitation-related intervention resulted in greater increases in MVPA or reductions in sedentary time compared to CBPR. Conclusion The addition of physical activity promotion to pulmonary rehabilitation improves volume of physical activity, but not intensity, compared to CBPR. High risk of bias and low certainty of evidence suggests that these results should be viewed with caution.
... One such app, myCOPD, was explored several times. The study by Bourne et al. confirmed that the app can improve inhaler use and exercise capacity in severe COPD through an online pulmonary rehabilitation program [13]. Crooks et al. evaluated the effect of the app in patients with mild-to-moderate or recently diagnosed COPD through an RCT study [14]. ...
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(1) Background: Digital medicine is developing in the management of chronic diseases in older people, but there is still a lack of information on the use of disease management apps in older patients with COPD. This study aims to explore the views and experience of older patients with COPD on disease management apps to provide a basis for the development and promotion of apps for geriatric diseases. (2) Methods: A descriptive qualitative research method was used. Older patients with COPD (N = 32) with experience using disease management apps participated in semi-structured interviews. Thematic analysis was used to analyze the data. (3) Results: Seven themes were defined: (a) feeling curious and worried when facing disease management apps for the first time; (b) actively overcoming barriers to use; (c) gradually becoming independent by continuous online learning; (d) feeling safe in the virtual environment; (e) gradually feeling new value in online interactions; (f) relying on disease management apps under long-term use; (g) expecting disease management apps to meet personalized needs. (4) Conclusions: The adoption and use of disease management apps by older people is a gradual process of acceptance, and they can obtain a wide range of benefits in health and life.
Conference Paper
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Background: Telehealth interventions in chronic obstructive pulmonary disease (COPD) management have garnered attention for their potential to enhance access to care and improve patient outcomes. Various studies have explored the effectiveness of telerehabilitation programs, innovative telemedicine platforms, and home-based PR initiatives in addressing the needs of COPD patients. Methods and materials: A selection criterion was determined after a thorough literature review across search engines and databases. SANRA guidelines were followed to draft the manuscript. Objectives: Exploring the impact of telehealth interventions on the effectiveness and the outcomes of pulmonary rehabilitation programs for patients with COPD. Discussions: The discussions revolve around the positive impact of telehealth interventions on exercise capacity, self-efficacy, and quality of life for COPD patients. Studies highlight the convenience and accessibility offered by telemedicine platforms as well as the effectiveness of in-home telerehabilitation programs. However, challenges such as technical issues, data security concerns, and disparities in access to technology need to be addressed for successful implementation.
Article
Currently, a major pulmonary rehabilitation focus is on expanding access. At-home rehabilitation is being explored as an in-center pulmonary rehabilitation alternative. It has been asserted that in-home pulmonary rehabilitation confers similar benefits to in-center pulmonary rehabilitation. An extensive database documents that in-center pulmonary rehabilitation confers a range of patient-relevant benefits. Recently, evidence has been presented that in-center pulmonary rehabilitation improves survival, perhaps the most important benefit of all. It can be argued that improvements in physical fitness, assessed as exercise capacity, are mechanistically related to survival improvements. Therefore, in-home rehabilitation must demonstrate exercise capacity improvements similar to those regularly seen in-center to be considered equivalent. A literature search identified 11 studies that compared in-home with in-center pulmonary rehabilitation for COPD that recorded exercise tolerance outcomes. Despite being described as in-home programs, almost all featured prefatory in-center evaluation; some featured in-home visits by rehabilitation professionals. In 6 of the 11 studies, only walking exercise was prescribed. Only 3 included 2-way audio/visual patient-therapist contact. With regard to exercise outcomes; in 3, there was greater in-center group improvement; in 4, outcomes were similar; and, in 4, the in-center group failed to demonstrate clinically important exercise outcome increases; decidedly mixed results. Importantly, in 8 of 11 studies, the 6-min walk test was an exercise outcome. It is argued that the 6-min walk test does not generally elicit physiologically maximum responses and cannot be used to assess exercise capacity improvements. Of the 4 studies that used other exercise outcomes, in 2, exercise endurance increase was similar between in-home and in-center groups; in the other 2, the in-center group had superior improvements. Mixed results indeed! In conclusion, there is insufficient evidence to conclude that in-home pulmonary rehabilitation yields improvements equivalent to center-based programs in physical function, the outcome likely driving long-term prognosis. Moreover, it needs to be established which of the wide variety of in-home program designs now being offered should be promoted.
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Background: Chronic obstructive pulmonary disease (COPD) is a common cause of morbidity and mortality affecting a large number of individuals in both developed and developing countries and it represents a significant financial burden for patients, families and society. Pulmonary rehabilitation (PR) is a multidisciplinary program that integrates components of exercise training, education, nutritional support, psychologi- cal support and self-care, resulting in an improvement in dyspnea, fatigue and quality of life. Despite its proven effectiveness and the strong scientific recommendations for its rou- tine use in the care of COPD, PR is generally underutilized and strategies for increasing access to PR are needed. Home- based self-monitored pulmonary rehabilitation is an alternative to outpatient rehabilitation. In the present study, patients with mild, moderate and severe COPD submitted to either an outpatient or at-home PR program for 12 weeks were analyzed. Methods: Patients who fulfilled the inclusion criteria were randomized into three distinct groups: an outpatient group who performed all activities at the clinic, a home-based group who performed the activities at home and a control group. PR consisted of a combination of aerobic exercises and strength- ening of upper and lower limbs 3 times a week for 12 weeks. Results: There was a significant difference in the distance cov- ered on the six-minute walk test (p < 0.05) and BODE index (p < 0.001) in the outpatient and at-home groups after partici- pating in the rehabilitation program compared to baseline. Conclusion: A home-based self-monitoring pulmonary reha- bilitation program is as effective as outpatient pulmonary rehabilitation and is a valid alternative for the management of patients with COPD.
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Background: Cardiac rehabilitation (CR) can slow or reverse the progression of cardiovascular disease (CVD). However, uptake of community-based CR is very low. E-cardiology, e-health and technology solutions for physical activity uptake and monitoring have evolved rapidly and have potential in CVD management. However, it is unclear what the current technology usage is of CVD patients, and their needs and interests for technology enabled CR. Methods: A technology usage questionnaire was developed and completed by patients from a supervised ambulatory CR program and an adult congenital heart disease clinic and from two community-based CR programs. Results were described and related with age, gender and educational level by Spearman correlations. Results: Of 310 patients, 298 patients (77 % male; mean age 61,7 ± 14,5 years) completed at least 25 questions of the survey and were included in the analysis (completion rate 96 %). Most (97 %) patients had a mobile phone and used the internet (91 %). Heart rate monitors were used by 35 % and 68 % reported to find heart rate monitoring important when exercising at home. Physical activity monitoring was reported by 12 % of the respondents. Respondents were interested in CR support through internet (77 %) and mobile phone (68 %). Many patients reported interest in game-based CR (67 %) and virtual rehabilitation (58 %). At least medium interest in technology enabled CR was reported by 75 % of the patients. Interest decreased with increasing age (r = -0.16; p = 0.005). Conclusions: CVD patients show interest for technology enabled home-based CR. Our results could guide the design of a technology-based, virtual CR intervention.
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Background Comprehensive multidisciplinary pulmonary rehabilitation is vital in the management of chronic obstructive pulmonary disease (COPD) and is considered for any stage of the disease. Rehabilitation programmes are often centre-based and organised in groups. However, the distance from the patient’s home to the centre and lack of transportation may hinder participation. Rehabilitation at home can improve access to care for patients regardless of disease severity. We had previously studied the technology usability and acceptability of a comprehensive home rehabilitation programme designed for patients with very severe COPD receiving long-term oxygen therapy. The acceptability of such comprehensive home programmes for those with less severe COPD, who may be less homebound, is not known. The aims of this feasibility study were to assess patient acceptability of the delivery mode and components of a comprehensive pulmonary rehabilitation programme for any stage of COPD, as well as the technology usability, patient outcomes and economic aspects. Methods Ten participants with COPD in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade I–IV were enrolled in a 9-week home programme and divided into two rehabilitation groups, with five patients in each group. The programme included exercise training and self-management education in online groups of patients, and individual online consultations. The patients also kept a digital health diary. To assess the acceptability of the programme, the patients were interviewed after the intervention using a semi-structured interview guide. In addition the number of sessions attended was observed. The usability of the technology was assessed using interviews and the System Usability Scale questionnaire. The St George’s Respiratory Questionnaire (SGRQ) was used to measure health-related quality of life. Results The mode of delivery and the components of the programme were well accepted by the patients. The programme provided an environment for learning from both healthcare professionals and peers, for asking questions and discussing disease-related issues and for group exercising. The patients considered that it facilitated health-enhancing behaviours and social interactions with a social group formed among the participants. Even participants who were potentially less homebound appreciated the home group and social aspects of the programme. The participants found the technology easy to learn and use. The acceptability and usability results were consistent with those in our previous study of patients with very severe COPD. Only the mean change in the SGRQ total score of −6.53 (CI 95 % −0.38 to −12.68, p = 0.04) indicates a probable clinically significant effect. Economic calculations indicated that the cost of the programme was feasible. Conclusions The results of this study indicate that comprehensive pulmonary rehabilitation delivered in home-based online groups may be feasible in COPD. The mode of delivery and components of the programme appeared to be acceptable across patients with different disease severity. The results in terms of patient outcomes are inconclusive, and further assessment is needed.
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Background: Self-management education for cardiopulmonary diseases is primarily provided through time-limited, face-to-face programs, with access limited to a small percentage of patients. Telecommunication tools will increasingly be an important component of future health care delivery. Objective: The purpose of this study was to describe the patterns of technology use in patients attending a cardiopulmonary clinic in an academic medical center. Methods: A prevalence survey was developed to collect data on participant demographics (age in years, sex, and socioeconomic status); access to computers, Internet, and mobile phones; and use of current online health support sites or programs. Surveys were offered by reception staff to all patients attending the outpatient clinic. Results: A total of 123 surveys were collected between March and April 2014. Technological devices were a pervasive part of everyday life with respondents engaged in regular computer (102/123, 82.9%), mobile telephone (115/117, 98.3%), and Internet (104/121, 86.0%) use. Emailing (101/121, 83.4%), researching and reading news articles (93/121, 76.9%), social media (71/121, 58.7%), and day-to-day activities (65/121, 53.7%) were the most common telecommunication activities. The majority of respondents reported that access to health support programs and assistance through the Internet (82/111, 73.9%) would be of use, with benefits reported as better understanding of health information (16/111, 22.5%), avoidance of difficult travel requirements and time-consuming face-to-face appointments (13/111, 18.3%), convenient and easily accessible help and information (12/111, 16.9%), and access to peer support and sharing (9/111, 12.7%). The majority of patients did not have concerns over participating in the online environment (87/111, 78.4%); the few concerns noted related to privacy and security (10/15), information accuracy (2/15), and computer literacy and access (2/15). Conclusions: Chronic disease burden and long-term self-management tasks provide a compelling argument for accessible and convenient avenues to obtaining ongoing treatment and peer support. Online access to health support programs and assistance was reported as useful and perceived as providing convenient, timely, and easily accessible health support and information. Distance from the health care facility and a lack of information provision through traditional health sources were both barriers and enablers to telehealth. This is particularly important in the context of a cardiopulmonary clinic that attracts patients from a large geographical area, and in patients who are most likely to have high health care utilization needs in the future. Telecommunication interfaces will be an increasingly important adjunct to traditional forms of health care delivery.
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Technology offers opportunities to improve healthcare, but little is known about Internet use by COPD patients. We tested two hypotheses: Internet access is associated with socio-demographic disparities and frequency of use is related to perceived needs. We analyzed data from a 2007-2008 national convenience sample survey of COPD patients to determine the relationship between Internet access and frequency of use with demographics, socio-economic status, COPD severity, and satisfaction with healthcare. Among survey respondents (response rate 7.2%; n = 914, 59.1% women, mean age 71.2 years), 34.2% reported lack of Internet access, and an additional 49% had access but used the Internet less than weekly. Multivariate models showed association between lack of access and older age (OR 1.10, 95% CI 1.07, 1.13), lower income (income below $30,000 OR 2.47, 95% CI 1.63, 3.73), less education (high school highest attainment OR 2.30, 95% CI 1.54, 3.45), comorbid arthritis or mobility-related disease (OR 1.56, 95% CI 1.05, 2.34). More frequent use (at least weekly) was associated with younger age (OR 0.95, 95% CI 0.93, 0.98), absence of cardiovascular disease (OR 0.48, 95% CI 0.29, 0.78), but with perception of needs insufficiently met by the healthcare system, including diagnostic delay (OR 1.72, 95% CI 1.06, 2.78), feeling treated poorly (OR 2.46, 95% CI 1.15, 5.24), insufficient physician time (OR 2.29, 95% CI 1.02, 5.13), and feeling their physician did not listen (OR 3.14, 95% CI 1.42, 6.95). An analysis of the characteristics associated with Internet access and use among COPD patients identified two different patient populations. Lack of Internet access was a marker of socioeconomic disparity and mobility-associated diseases, while frequent Internet use was associated with less somatic disease but dissatisfaction with care.
Article
The goal of the New Policy Statement is to expand provision of pulmonary rehabilitation to suitable patients worldwide. In December 2015, the Official American Thoracic Society (ATS)/European Respiratory Society (ERS) Policy Statement on Enhancing Implementation, Use and Delivery of Pulmonary Rehabilitation was published [1] with the aim of providing policy recommendations to increase implementation and delivery of pulmonary rehabilitation worldwide. Major areas addressed included increasing healthcare professional, payer and patient awareness and knowledge of pulmonary rehabilitation, increasing patient access to pulmonary rehabilitation, improving quality of pulmonary rehabilitation programmes and future research directions to advance evidence-based policy in pulmonary rehabilitation. This ATS/ERS document was developed via an iterative consensus process by an ad hoc Task Force on Policy in pulmonary rehabilitation comprised of experts from the ATS Pulmonary Rehabilitation Assembly, the ERS Rehabilitation and Chronic Care Group, the ATS and ERS Documents Development and Implementation Committees, representatives from the European Lung Foundation (ELF) and primary care representatives from the USA and Europe between May 2013 and January 2015. Input was obtained via informal surveys from patients, patient advocacy groups, (including the ATS Public Advisory Roundtable and ELF), insurance payers, as well as primary and pulmonary specialty healthcare providers. The Policy Statement was approved by the Board of Directors of the ATS and the Science Council and Executive Committee of the ERS. This editorial provides European Respiratory Journal readers with a concise reflection on the key issues addressed and summarises the policy recommendations made in the ATS/ERS Policy Statement [1] to enhance implementation, use and delivery of pulmonary rehabilitation.
Article
Background: The Internet could provide a means of delivering secondary prevention programmes to people with coronary heart disease (CHD). Objectives: To determine the effectiveness of Internet-based interventions targeting lifestyle changes and medicines management for the secondary prevention of CHD. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, in December 2014. We also searched six other databases in October 2014, and three trials registers in January 2015 together with reference checking and handsearching to identify additional studies. Selection criteria: Randomised controlled trials (RCTs) evaluating Internet-delivered secondary prevention interventions aimed at people with CHD. Data collection and analysis: Two review authors independently assessed risk of bias and extracted data according to the Cochrane Handbook for Systematic Reviews of Interventions. We assessed evidence quality using the GRADE approach and presented this in a 'Summary of findings' table. Main results: Eighteen trials met our inclusion criteria. Eleven studies are complete (1392 participants), and seven are ongoing. Of the completed studies, seven interventions are broad, targeting the lifestyle management of CHD, and four focused on physical activity promotion. The comparison group in trials was usual care (n = 6), minimal intervention (n = 3), or traditional cardiac rehabilitation (n = 2).We found no effects of Internet-based interventions for all-cause mortality (odds ratio (OR) 0.27, 95% confidence interval (CI) 0.04 to 1.63; participants = 895; studies = 6; low-quality evidence). There was only one case of cardiovascular mortality in a control group (participants = 895; studies = 6). No incidences of non-fatal re-infarction were reported across any of the studies. We found no effects for revascularisation (OR 0.69, 95% CI 0.37 to 1.27; participants = 895; studies = 6; low-quality evidence).We found no effects for total cholesterol (mean difference (MD) 0.00, 95% CI -0.27 to 0.28; participants = 439; studies = 4; low-quality evidence), high-density lipoprotein (HDL) cholesterol (MD 0.01, 95% CI -0.06 to 0.07; participants = 437; studies = 4; low-quality evidence), or triglycerides (MD 0.01, 95% CI -0.17 to 0.19; participants = 439; studies = 4; low-quality evidence). We did not pool the data for low-density lipoprotein (LDL) cholesterol due to considerable heterogeneity. Two out of six trials measuring LDL cholesterol detected favourable intervention effects, and four trials reported no effects. Seven studies measured systolic and diastolic blood pressure; we did not pool the data due to substantial heterogeneity. For systolic blood pressure, two studies showed a reduction with the intervention, but the remaining studies showed no effect. For diastolic blood pressure, two studies showed a reduction with the intervention, one study showed an increase with the intervention, and the remaining four studies showed no effect.Five trials measured health-related quality of life (HRQOL). We could draw no conclusions from one study due to incomplete reporting; one trial reported no effect; two studies reported a short- and medium-term effect respectively; and one study reported both short- and medium-term effects.Five trials assessed dietary outcomes: two reported favourable effects, and three reported no effects. Eight studies assessed physical activity: five of these trials reported no physical activity effects, and three reported effectiveness. Trials are yet to measure the impact of these interventions on compliance with medication.Two studies measured healthcare utilisation: one reported no effects, and the other reported increased usage of healthcare services compared to a control group in the intervention group at nine months' follow-up. Two trials collected cost data: both reported that Internet-delivered interventions are likely to be cost-effective.In terms of the risk of bias, the majority of studies reported appropriate randomisation and appropriate concealment of randomisation processes. A lack of blinding resulted in a risk of performance bias in seven studies, and a risk of detection bias in five trials. Two trials were at risk of attrition bias, and five were at risk for reporting bias. Authors' conclusions: In general, evidence was of low quality due to lack of blinding, loss to follow-up, and uncertainty around the effect size. Few studies measured clinical events, and of those that did, a very small number of events were reported, and therefore no firm conclusions can be made. Similarly, there was no clear evidence of effect for cardiovascular risk factors, although again the number of studies reporting these was small. There was some evidence for beneficial effects on HRQOL, dietary outcomes, and physical activity, although firm conclusions cannot yet be made. The effects on healthcare utilisation and cost-effectiveness are also inconclusive, and trials are yet to measure the impact of Internet interventions on compliance with medication. The comparison groups differed across trials, and there were insufficient studies with usable data for subgroup analyses. We intend to study the intensity of comparison groups in future updates of this review when more evidence is available. The completion of the ongoing trials will add to the evidence base.
Article
BACKGROUND Pulmonary rehabilitation programmes have been shown to improve both exercise tolerance and health status in patients with chronic obstructive pulmonary disease (COPD). The optimal duration for a pulmonary rehabilitation programme is, however, unknown. To assess whether the current pulmonary rehabilitation programme could be shortened a randomised controlled trial was conducted in 44 patients with COPD who were allocated to either a seven week or a four week course. METHODS Patients were randomised to either our standard seven week twice weekly outpatient based programme or a comparable but shortened four week course. They were assessed at baseline and at completion by the Chronic Respiratory Questionnaire (CRQ), the Breathing Problems Questionnaire (BPQ), the incremental shuttle walking test (SWT), and the treadmill endurance test (TET). RESULTS Twenty one patients (61% men) of mean (SD) age 68 (9.2) years and forced expiratory volume in one second ( FEV1) 1.08 (0.4) l completed a conventional seven week course and 23 (67% men) of mean (SD) age 69 (8.8) years and FEV1 1.03 (0.3) l completed a shortened four week course. Patients who completed the seven week rehabilitation programme had greater improvements in all outcome measures than those undertaking the four week course. These differences reached clinical and statistical significance for the total CRQ score, which was the primary outcome variable (mean difference (95% confidence intervals (CI) of difference) –0.61(–0.15 to –1.08), p<0.05), and the CRQ domains of dyspnoea (–0.80 (95% CI –0.13 to –1.48), p<0.05), emotion (–0.89 (95% CI –0.33 to –1.45), p<0.005), and mastery (–0.84 (95% CI –0.10 to –1.58), p<0.05). There were also trends towards greater improvements in exercise assessments in the seven week group but the differences did not reach statistical significance (SWT: mean difference –16.9 (95% CI 24.8 to –58.6), p=0.41; TET: geometric mean difference –1.21 (95% CI –0.60 to –2.47), p=0.56). CONCLUSIONS A seven week course of pulmonary rehabilitation provides greater benefits to patients than a four week course in terms of improvements in health status. Larger prospective studies are required to determine the optimal duration of a pulmonary rehabilitation programme.
Article
Background: Widespread application of pulmonary rehabilitation (also known as respiratory rehabilitation) in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function (health-related quality of life, functional and maximal exercise capacity) attributable to the programmes. This review updates the review reported in 2006. Objectives: To compare the effects of pulmonary rehabilitation versus usual care on health-related quality of life and functional and maximal exercise capacity in persons with COPD. Search methods: We identified additional randomised controlled trials (RCTs) from the Cochrane Airways Group Specialised Register. Searches were current as of March 2014. Selection criteria: We selected RCTs of pulmonary rehabilitation in patients with COPD in which health-related quality of life (HRQoL) and/or functional (FEC) or maximal (MEC) exercise capacity were measured. We defined 'pulmonary rehabilitation' as exercise training for at least four weeks with or without education and/or psychological support. We defined 'usual care' as conventional care in which the control group was not given education or any form of additional intervention. We considered participants in the following situations to be in receipt of usual care: only verbal advice was given without additional education; and medication was altered or optimised to what was considered best practice at the start of the trial for all participants. Data collection and analysis: We calculated mean differences (MDs) using a random-effects model. We requested missing data from the authors of the primary study. We used standard methods as recommended by The Cochrane Collaboration. Main results: Along with the 31 RCTs included in the previous version (2006), we included 34 additional RCTs in this update, resulting in a total of 65 RCTs involving 3822 participants for inclusion in the meta-analysis.We noted no significant demographic differences at baseline between members of the intervention group and those who received usual care. For the pulmonary rehabilitation group, the mean forced expiratory volume at one second (FEV1) was 39.2% predicted, and for the usual care group 36.4%; mean age was 62.4 years and 62.5 years, respectively. The gender mix in both groups was around two males for each female. A total of 41 of the pulmonary rehabilitation programmes were hospital based (inpatient or outpatient), 23 were community based (at community centres or in individual homes) and one study had both a hospital component and a community component. Most programmes were of 12 weeks' or eight weeks' duration with an overall range of four weeks to 52 weeks.The nature of the intervention made it impossible for investigators to blind participants or those delivering the programme. In addition, it was unclear from most early studies whether allocation concealment was undertaken; along with the high attrition rates reported by several studies, this impacted the overall risk of bias.We found statistically significant improvement for all included outcomes. In four important domains of quality of life (QoL) (Chronic Respiratory Questionnaire (CRQ) scores for dyspnoea, fatigue, emotional function and mastery), the effect was larger than the minimal clinically important difference (MCID) of 0.5 units (dyspnoea: MD 0.79, 95% confidence interval (CI) 0.56 to 1.03; N = 1283; studies = 19; moderate-quality evidence; fatigue: MD 0.68, 95% CI 0.45 to 0.92; N = 1291; studies = 19; low-quality evidence; emotional function: MD 0.56, 95% CI 0.34 to 0.78; N = 1291; studies = 19; mastery: MD 0.71, 95% CI 0.47 to 0.95; N = 1212; studies = 19; low-quality evidence). Statistically significant improvements were noted in all domains of the St. George's Respiratory Questionnaire (SGRQ), and improvement in total score was better than 4 units (MD -6.89, 95% CI -9.26 to -4.52; N = 1146; studies = 19; low-quality evidence). Sensitivity analysis using the trials at lower risk of bias yielded a similar estimate of the treatment effect (MD -5.15, 95% CI -7.95 to -2.36; N = 572; studies = 7).Both functional exercise and maximal exercise showed statistically significant improvement. Researchers reported an increase in maximal exercise capacity (mean Wmax (W)) in participants allocated to pulmonary rehabilitation compared with usual care (MD 6.77, 95% CI 1.89 to 11.65; N = 779; studies = 16). The common effect size exceeded the MCID (4 watts) proposed by Puhan 2011(b). In relation to functional exercise capacity, the six-minute walk distance mean treatment effect was greater than the threshold of clinical significance (MD 43.93, 95% CI 32.64 to 55.21; participants = 1879; studies = 38).The subgroup analysis, which compared hospital-based programmes versus community-based programmes, provided evidence of a significant difference in treatment effect between subgroups for all domains of the CRQ, with higher mean values, on average, in the hospital-based pulmonary rehabilitation group than in the community-based group. The SGRQ did not reveal this difference. Subgroup analysis performed to look at the complexity of the pulmonary rehabilitation programme provided no evidence of a significant difference in treatment effect between subgroups that received exercise only and those that received exercise combined with more complex interventions. However, both subgroup analyses could be confounded and should be interpreted with caution. Authors' conclusions: Pulmonary rehabilitation relieves dyspnoea and fatigue, improves emotional function and enhances the sense of control that individuals have over their condition. These improvements are moderately large and clinically significant. Rehabilitation serves as an important component of the management of COPD and is beneficial in improving health-related quality of life and exercise capacity. It is our opinion that additional RCTs comparing pulmonary rehabilitation and conventional care in COPD are not warranted. Future research studies should focus on identifying which components of pulmonary rehabilitation are essential, its ideal length and location, the degree of supervision and intensity of training required and how long treatment effects persist. This endeavour is important in the light of the new subgroup analysis, which showed a difference in treatment effect on the CRQ between hospital-based and community-based programmes but no difference between exercise only and more complex pulmonary rehabilitation programmes.