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Frailty intervention trial (FIT)

Authors:
Nicola Fairhall at The University of Sydney
Nicola Fairhall
Christina Aggar at NNSW Local Health District and Southern Cross University
Christina Aggar
  • NNSW Local Health District and Southern Cross University
Susan Kurrle at The University of Sydney
Susan Kurrle
Catherine Sherrington at School of Public Health, University of Sydney
Catherine Sherrington
  • School of Public Health, University of Sydney
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Abstract and Figures

Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further functional decline and institutionalisation. The strategies to be examined are readily transferable to routine clinical practice and are applicable broadly in the setting of aged care health services. Australian New Zealand Clinical Trails Registry: ACTRN12608000250336.
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... Recent studies have examined rehabilitation strategies in prefrail individuals. 15 From frailty assessment to rehabilitation program development Due to the increasing use of the ICF scale in healthcare, the proposed approach to rehabilitation is to always identify initially the degree of frailty according to ICF scale categorizations. In addition, it is well known that older people may be unaware of self-existing health implications (functional, psychological, social), therefore it may be imperative to perform a comprehensive geriatric assessment (CGA), a process that identifies medical, psychosocial, functional, and environmental problems and creates a comprehensive treatment and monitoring program, aiming to improve patients' overall health status. ...
... 24 The FIT program used the ICF scale to classify the common patterns that exist as part or in combination with the frailty syndrome and identified their causes, which are described below. 8,15 The FIT intervention program includes exercise prescription, nutritional assessment, and counseling sessions by a Geriatrician or Physiatrist. The integrated geriatric intervention accommodates a coordinating role (general practitioner-service provider), supporting individual participation in life roles, and provides advice for appropriate equipment acquisition and drug interventions. ...
... Frailty data are identified (as defined by Fried and colleagues) in each participant, while additional interventions are performed based on the CGA, including chronic disease and pain management, and other recognized syndromes or conditions (i.e., urinary incontinence). 15 However, it is recommended that, the most common exercise interventions against frailty are a combination of endurance and strengthening exercises, of a 3-month duration with a 3x/week frequency, lasting one hour each session. However, it is recommended that long-term complex interventions should last approximately 30-45 minutes to avoid potential adverse outcomes. ...
Frailty: future prospectives in rehabilitation medicine
Article
Full-text available
  • Jun 2023
Modern rehabilitation is based on the International Classification of Functioning, Disability and Health (ICF). We will discuss this Classification process in frailty. Frailty is defined as a condition of reduced functional reserve, a state of vulnerability that involves poor recovery of homeostasis and increased susceptibility to stressor mechanisms, with consequent difficulty in returning to the previous condition of balance. Rehabilitation of frailty is reported in the ICF, although, its consensus is not sufficiently addressed due to its recent identification and the limited available information regarding how it should be formulated. Thus, the aim of the present article is to present the current evidence-based rehabilitation strategies applied in management of frailty.
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... However, other community-based alternatives to physiotherapy to prevent or reduce physical decline and frailty are not yet established. As part of the Australian Frailty Intervention Trial (FIT) project [7], a multifactorial, interdisciplinary intervention program was shown to be (cost-) effective in reducing frailty, mobility limitations, and the fall risk [8][9][10]. The main component of the FIT project is a home-based training program (WEBB = "Weight-bearing Exercise for Better Balance") supervised by a physiotherapist, which can be complemented by optional counseling services [11]. ...
... To accurately assess the costeffectiveness of recruitment strategies, whether they involve medical referrals or direct mailings, it is essential to standardize the analysis and reporting methods [45]. The overall participant characteristics of the study sample are comparable to the recent prevention trials in communitydwelling (pre-)frail older people, such as the Australian FIT trial [7] or the Finnish HIPFRA (Home physiotherapy for HIP fracture and FRAilty) trial [46]. The differences in participant characteristics with respect to the recruitment strategy, showing that participants recruited through GPs were more frail and less physically fit, participative, and mobile in their life space, may be due to an effect of extrinsic and intrinsic motivation. ...
Prevention at home in older persons with (pre-)frailty: analysis of participants’ recruitment and characteristics of the randomized controlled PromeTheus trial
Article
Full-text available
  • May 2024
  • AGING CLIN EXP RES
Background The “PromeTheus” trial is evaluating a home-based, multifactorial, interdisciplinary prevention program for community-dwelling (pre-)frail older adults. These individuals often suffer from reduced participation, which can complicate the recruitment and enrollment in a clinical trial. Aims The aim of this study was to evaluate different recruitment strategies and differences in participant characteristics in relation to these strategies. Methods This cross-sectional study used baseline data from the randomized-controlled PromeTheus trial, in which community-dwelling (pre-)frail older persons (Clinical Frailty Scale [CFS] 4–6 pt., ≥ 70 years) were recruited via general practitioners (“GP recruitment”) or flyers, newspaper articles, and personalized letters (“direct recruitment”). Differences in the sociodemographic, clinical, physical, functional, mobility-related, psychological and social characteristics were analyzed in relation to the recruitment strategy. Results A total of 385 participants (mean age = 81.2, SD 5.9 years; women: n = 283, 73.5%) were enrolled, of which 60 (16%) were recruited by GPs and 325 (84%) through direct recruitment. Participants recruited via GPs had significantly higher subjective frailty levels (CFS), were more often physically frail (Fried Frailty Phenotype), and showed lower physical capacity (Short Physical Performance Battery), participation (disability component of the short version of the Late-Life Function and Disability Instrument), and life-space mobility (Life-Space Assessment) compared to those recruited via the direct approach (p = 0.002–0.026). Costs per randomized participant were 94€ for the GP recruitment strategy and €213 for the direct recruitment strategy. Conclusion Different strategies may be required to successfully recruit (pre-)frail home-living older adults into preventive programs. Direct recruitment strategies, in which potential participants are directly informed about the prevention program, seem to be more promising than GP recruitment but may result in enrolment of persons with less functional impairment and higher recruitment costs. Trial registration German Clinical Trials Register, DRKS00024638. Registered on March 11, 2021.
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... There have been several studies examining frailty and potentially associated factors among patients during hospitalization and outpatient clinic visits, while there have been only few studies making extensive assessments of older people living in the community 6,8,[18][19][20][21][22] . There have also been studies conducted in our country evaluating the older inpatients and outpatients admitted to family health centers. ...
... The association between these two factors is two-sided and embedded 5,8,21,24 . Similar to other national studies, the results of our study showed an association between falls and frailty in community-dwelling older adults 18,[20][21][22][23][24] . Again, it was conducted in our society. ...
Frailty and its associates in community-dwelling older adults
Article
Full-text available
  • Nov 2023
OBJECTIVE: While the literature contains several studies on the frailty assessed during hospitalization and/or outpatient settings and nursing homes, few studies have assessed frailty in community-dwelling older adults. We investigated the prevalence of frailty and associated factors among older adults in a sample of community-dwelling older adults. METHODS: We included community-dwelling older adults >60 years living in the Fatih District of the Istanbul Province. We conducted the study between November 2014 and May 2015. We collected the data such as age, sex, number of diseases and drugs, functional status, frailty, the presence of geriatric syndromes, common diseases, and quality-of-life assessment. Frailty was evaluated by the FRAIL scale. RESULTS: A total of 204 adults (mean age: 75.4±7.3 years) were included, of whom 30.4% were robust, 42.6% were pre-frail, and 27% were frail. In multivariate analyses, associated factors of frailty were the number of drugs [odds ratio (OR)=1.240, p=0.036], the presence of cognitive impairment (OR=0.300, p=0.016), and falls (OR=1.984, p=0.048). CONCLUSION: The present study established the prevalence of frailty in a large district in the largest metropolis in the country through a valid screening method. Our results suggest that clinicians should consider frailty evaluation in patients with multiple drug usage, cognitive impairment, and falls.
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... Frailty is characterized as a prominent geriatric syndrome arising from the progressive decline in physiological reserves within the neuromuscular, metabolic, and immune systems with advancing age (4). Predominant symptoms encompass weight loss, weakness, fatigue, and reduced mobility, whereas notable observations entail sarcopenia, osteopenia, malnutrition, compromised balance, and coordination, as well as deceleration in walking speed (5). Challenges in assessing frailty within the clinical routine of breast cancer patients are well recognized (6). ...
Effect of complex decongestive therapy on frailty and quality of life in women with breast cancer-related lymphedema: the before-and-after treatment study
Article
Full-text available
  • May 2024
Objective To investigate the impact of Complex Decongestive Therapy (CDT) on the severity of frailty and quality of life in individuals suffering from postmastectomy lymphedema syndrome. Methods Participants who met the inclusion criteria were informed about CDT and informed consent was obtained. Edmonton Frailty Scale (EFS), extremity volüme (EV), lymphedema stage(LS), EQ-5D General Quality of Life Scale (EQ-5D-5L), and Quick Disabilities of Arm, Shoulder, and Hand (DASH) scores were evaluated by the same physician before and after treatment. A total of 15 sessions of CDT were performed for 3 weeks, five days a week. During the treatment period, hospitalized patients received guidance from a nurse on protecting the affected arm in their daily routine. Results Eighty patients with breast cancer-related lymphedema who met the inclusion criteria were included in the study. Following a period of 3 weeks of practice and training, the specialist physician conducted the final evaluation and assessments. All patients showed a statistically significant reduction in EV, and regression in LS, EFS, and Quick DASH score (p<0.001). Statistically significant improvement was also observed in quality of life and general health status. (p<0.001). Conclusion The application of 15 sessions of CDT and educational interventions to women with postmastectomy lymphedema syndrome due to breast cancer yielded positive outcomes. This approach led to an enhancement in patients’ functional capacity, improving their quality of life and a subsequent reduction in the severity of frailty.
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... This poses burdens in the study of frailty since using a reference tool in which some dimensions may not be validated renders a study doubtful. This has already triggered researchers in the field to modify Fried criteria in order to make them usable in country level [32][33][34]. The fact that the Minnesota Leisure Time Activity questionnaire was used to estimate physical inactivity in the original Fried study [6], that is not translated or validated in Greek and that there are no other tools specifically designed to evaluate physical activity levels of older adults in order to classify them as active or inactive accordingly, renders it important to assess physical inactivity by using a cut-off value and then evaluate its accuracy. ...
Pilot Testing of Useful Tools Validity for Frailty Assessment in Greece: Translated PRISMA-7 Tool, Modified Fried Criteria and Clinical Frailty Scale
Preprint
Full-text available
  • Mar 2024
The importance of frailty in older people is getting constant recognition as an important aspect both in terms of public health, as well in personal level for the appropriate management of an older person health condition. This is reflected by the continuously increasing number of research studies carried out in several settings across different countries. Sometimes this is very solid, but in other cases there is a considerable gap in terms of accurate and well grounded documentation of frailty status. This is the case in Greece, where we are missing clinically validated tools to approach frailty. We are missing frailty screening tools, such as for instance PRISMA 7, the gold standard tool of Fried criteria is somehow problematic since the question referring to physical activity originates from a questionnaire that has not been translated and validated, while Clinical Frailty Scale has been validated for the translation but not for the capacity to detect frailty. Aim of this study is to validate these tools for their accuracy to detect frailty by using a measurable index of frailty, previously proposed for use in clinical studies: the Short Physical Performance Battery (SPPB). 74 male and female participants have been evaluated for their frailty status using different tools. We observed that PRISMA 7 translation detects frailty only when one question is removed at a cut-off of ≥ 2 and indicated a sensitivity of 88.1%, and specificity of 99.9% with a good correlation with SPPB measurements (r = 0.858; p < 0.001). When CFS was validated using SPPB it demonstrated a very good correlation (r = -0.838; p < 0.001 respectively) as it was the case for the modified Fried Criteria (r = -0.725; p < 0.001). All items demonstrated a good correlation between them. We can here propose that we can accurately assess frailty status in the community setting by using a modified version of Fried criteria, Clinical Frailty Scale translation in Greek and we can screen for frailty by using the Greek translation of PRISMA 7 only after removing the item 6 of the questionnaire.
View
... This poses burdens in the study of frailty, since using a reference tool in which some dimensions may not be validated renders a study doubtful. This has already triggered researchers in the field to modify Fried criteria in order to make them usable at the country level [32][33][34]. Considering that the Minnesota Leisure Time Activity questionnaire used to estimate physical inactivity in the original Fried study [6] is not translated or validated in Greek and that there are no other tools specifically designed to evaluate physical activity levels of older adults in order to classify them as active or inactive accordingly, it becomes important to assess physical inactivity by using arbitrary cut-off values and then evaluating their accuracy. ...
Pilot Testing of Useful Tools’ Validity for Frailty Assessment in Greece: Translated PRISMA-7 Tool, Modified Fried Criteria and Clinical Frailty Scale
Article
Full-text available
  • Apr 2024
The importance of frailty in older people is getting constant recognition as an important aspect both in terms of public health, as well as at a personal level, for the appropriate management of an older person’s health condition. This is reflected by the continuously increasing number of research studies carried out in several settings across different countries. Sometimes, this is very solid, but in other cases, there is a considerable gap in terms of accurate and well-grounded documentation of frailty status. This is the case in Greece, where we are missing clinically validated tools to approach frailty. We are missing frailty screening tools, such as, for instance, Program of Research on Integration of Services for the Maintenance of Autonomy 7 (PRISMA 7), the gold standard tool of Fried criteria, is somehow problematic since the question referring to physical activity originates from a questionnaire that has not been translated and validated, while Clinical Frailty Scale (CFS) has been validated for translation but not for the capacity to detect frailty. The aim of this study is to validate these tools for their accuracy to detect frailty by using a measurable index of frailty, previously proposed for use in clinical studies: the Short Physical Performance Battery (SPPB). Seventy-four male and female participants (mean age 80.47 years SD = ±7.45 years, minimum–maximum age = 65–95) have been evaluated for their frailty status using different tools. We observed that the PRISMA 7 translation detects frailty only when one question is removed at a cut-off of ≥2 and indicates a sensitivity of 88.1% and specificity of 99.9% with a good correlation with SPPB measurements (r = −0.858; p < 0.001). When CFS was validated using SPPB, it demonstrated a very good correlation (r = −0.838; p < 0.001 respectively) as was the case for the modified Fried Criteria (r = −0.725; p < 0.001). All items demonstrated a good correlation between them. We here propose that we can accurately assess frailty status in the community setting by using a modified version of Fried criteria, Clinical Frailty Scale translation in Greek, and we can screen for frailty by using the Greek translation of PRISMA 7 only after removing item 6 of the questionnaire.
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... In anderen Ländern wurden bereits entsprechende Programme entwickelt, die gezielt auf die individuellen Defizite dieser vulnerablen Personengruppe eingehen. Im Rahmen des australischen "Frailty Intervention Trials" (FIT) [29] konnten durch ein multifaktorielles, interdisziplinäres Interventionsprogramm die Frailty, Einschränkungen in der Mobilität und das Sturzrisiko (kosten-)effektiv verringert werden. ...
Therapie der physischen Frailty
Article
  • Dec 2023
As an overarching geriatric syndrome, frailty describes a potentially reversible transitional stage between functional autonomy and irreversible disability. Thus, frailty addresses a “window of opportunity” in which functional limitations can be successfully treated. This article provides an overview of the therapeutic approaches and their scientific evidence.
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... Several landmark clinical trials have investigated the impact of exercise on cognitive function in individuals at risk of or diagnosed with AD. The Fitness Intervention Trial (FIT) is a notable example in this regard (42). This randomized controlled trial involved older adults with MCI and assessed the effects of a moderate-intensity aerobic exercise program on cognitive performance. ...
Sports and Alzheimer’s Disease: The Role of Physical Activity in Cognition Health
Article
Full-text available
  • Aug 2023
Alzheimer’s disease (AD) is an advancing neurodegenerative condition distinguished by a gradual deterioration of cognitive functions, including memory impairment and diminished functional capabilities. The issue presents a substantial global public health concern, as there is a growing prevalence of affected persons annually. In the pursuit of innovative strategies to delay or mitigate the beginning of AD, scholars have turned their attention to the exploration of physical activity as a potentially fruitful area of study. This review aims to investigate the correlation between engagement in sports activities and the development of AD. It will analyze the potential advantages of physical exercise on cognitive well-being and discuss the significance of these findings for strategies related to the prevention and treatment of the disease. We integrate data derived from epidemiological investigations, clinical trials, and neuroscientific inquiries, thereby emphasizing the existing body of knowledge in this pivotal domain.
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Effectiveness of lower limb rehabilitation protocol using mobile health on quality of life, functional strength, and functional capacity among knee osteoarthritis patients who are overweight and obese: A randomized-controlled trial
Article
Full-text available
  • Oct 2023
Objectives: This study aims to investigate the effectiveness of the lower limb rehabilitation protocol (LLRP) using mobile health (mHealth) on quality of life (QoL), functional strength, and functional capacity among knee OA patients who were overweight and obese. Patients and methods: Between August 2019 and November 2020, a total of 96 patients (42 males, 54 females; mean age; 52.9±4.8 years; range, 40 to 60 years) were randomized into either the rehabilitation group with mobile health (RGw-mHealth) receiving reminders by using mHealth to carry on the strengthening exercises of LLRP and instructions of daily care (IDC), the rehabilitation group without mobile health (RGwo-mHealth) following the strengthening exercises of LLRP and instructions of daily care (IDC) and control group (CG) only following the IDC for duration of 12 weeks. The reminders for using mHealth were provided two times a day for three days a week. Primary outcome measures were QoL assessed by the Western Ontario and McMaster Universities Osteoarthritis Index summary score, and functional strength by five-repetition sit-to-stand test. Secondary outcome measure was functional capacity assessed by the Gait Speed Test. The assessments of QoL, functional strength, and functional capacity were taken at baseline and post-test after 12 weeks of intervention. Results: After 12 weeks of intervention, the patients in all three groups had a statistically significant improvement in QoL within groups (p<0.05). Patients in the RGw-mHealth and RGwo-mHealth had a statistically significant improvement in functional strength and walking gait speed within groups (p<0.05). The pairwise between-group comparisons (Bonferroni post-hoc test) of the mean changes in QoL, functional strength, and functional capacity at post-test assessments revealed that patients in the RGw-mHealth had a statistically significant greater mean change in QoL, functional strength and functional capacity relative to both the RGwo-mHealth and CG (p<0.001). Conclusion: The improvement in QoL, functional strength, and functional capacity was greater among patients in the RGw-mHealth compared to the RGwo-mHealth or CG.
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The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Article
  • Apr 2001
Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site (http://www.consort -statement.org) should be helpful resources to improve reporting of randomized trials.
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Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial
Article
  • Mar 2001
Objectives: To assess the effectiveness of a trained district nurse individually prescribing a home based exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme. Design: Randomised controlled trial with one year's follow up. Setting: Community health service at a New Zealand hospital. Participants: 240 women and men aged 75 years and older. Intervention: 121 participants received the exercise programme (exercise group) and 119 received usual care (control group); 90% (211 of 233) completed the trial. Main outcome measures: Number of falls, number of injuries resulting from falls, costs of implementing the programme, and hospital costs as a result of falls. Results: Falls were reduced by 46% (incidence rate ratio 0.54, 95% confidence interval 0.32 to 0.90). Five hospital admissions were due to injuries caused by falls in the control group and none in the exercise group. The programme cost $NZ1803 (£523) (at 1998 prices) per fall prevented for delivering the programme and $NZ155 per fall prevented when hospital costs averted were considered. Conclusion: A home exercise programme, previously shown to be successful when delivered by a physiotherapist, was also effective in reducing falls when delivered by a trained nurse from within a home health service. Serious injuries and hospital admissions due to falls were also reduced. The programme was cost effective in participants aged 80 years and older compared with younger participants.
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The CES-D Scale: A Self-Report Depression Scale for Research in the General Population
Article
  • Jun 1977
  • APPL PSYCH MEAS
The CES-D scale is a short self-report scale designed to measure depressive symptomatology in the general population. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. The new scale was tested in household interview surveys and in psychiatric settings. It was found to have very high internal consistency and adequate test- retest repeatability. Validity was established by pat terns of correlations with other self-report measures, by correlations with clinical ratings of depression, and by relationships with other variables which support its construct validity. Reliability, validity, and factor structure were similar across a wide variety of demographic characteristics in the general population samples tested. The scale should be a useful tool for epidemiologic studies of de pression.
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