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Increasing participation. A sub-study of the Frailty Intervention Trial (FIT).

The effect of a goal-focussed exercise program on participation outcomes in frail older people, when compared with usual care. This project is a sub-study of the Frailty Intervention Trial (FIT), ACTRN12608000250336.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000507381
Enrollment
241
Registered
2008-09-30
Start date
2008-01-15
Completion date
2011-06-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a sub-study of the Frailty Intervention Trial (FIT), ACTRN12608000250336. Please refer to ACTRN12608000250336 for a brief summary of the FIT. This sub-study will examine the effect of a goal-focused exercise program on participation in frail, community-dwelling older persons. Participation is defined within the International Classification of Functioning, Disability and Health (ICF) as ‘the individual’s role in a life situation’. The term ‘participation’ evolved from the concept of ‘handicap’, when the ICF reconceptualised disability with the inclusion of the social model. Despite being a key goal of rehabilitation, participation has not been adequately investigated in the frail population. Due to its polyfactorial aetiology, participation can be influenced by intervention, despite the presence of irreversible health conditions and activity limitations in frail people. The interventions proven to modify the remediable clinical, personal and environmental determinants of participation have been combined to form a treatment protocol. The current trial will investigate the effect of an exercise program and goal-focussed barrier modification on participation restriction. Participants recruited for the Frailty Intervention Trial will be invited to take part in the sub-study. In addition to the exercise program provided to the intervention group in the Frailty Intervention Trial, the intervention group will receive two additional physiotherapy sessions. The additional intervention is an individually prescribed program that targets the goals of the individual, with respect to their participation in the home or community environment. The intervention will target potentially remediable barriers to reaching the individual's participation goal eg. walking capacity, social support and community environment. The primary outcome sought is a reduction in the rate of restricted participation. The primary outcome measurements are the Reintegration into Normal Living Index, Goal Attainment Scale and the Life Space Assessment. Secondary outcomes measured are participation, using the question: 'Do you get out of the house as much as you would like?', and the ability to perform activity, measured using the Activity Measure for Post Acute Care and Nottingham Extended Activities of Daily Living Index. A secondary analysis will be conducted to see whether there was an interaction between group allocation and cognition. i.e. Did the effect of the intervention vary according to cognitive status? This sub-study will boost the scant evidence-base for increasing participation in the older person. Combined with outcomes from the Frailty Intervention Trial, this sub-study will provide a more comprehensive understanding of the level of function and disability in the frail population and will enhance understanding of intervention to increase function in the frail population.

Interventions

This is a sub-study of the Frailty Intervention Trial (ACTRN12608000250336). The intervention group will participate in ten home-based physiotherapy sessions and a daily home exercise program, over the course of one year. The home-based physiotherapy sessions begin with an initial assessment of approximately two hours duration, with the information obtained allowing the therapist to tailor intervention to the individual participant's needs. The remaining nine home-based physiotherapy session

This is a sub-study of the Frailty Intervention Trial (ACTRN12608000250336). The intervention group will participate in ten home-based physiotherapy sessions and a daily home exercise program, over the course of one year. The home-based physiotherapy sessions begin with an initial assessment of approximately two hours duration, with the information obtained allowing the therapist to tailor intervention to the individual participant's needs. The remaining nine home-based physiotherapy sessions are of one hour duration. They involve two components: the Weight-bearing Exercise for Better Balance (WEBB) program and training to meet the individual’s participation goals. The WEBB program was developed by Sherrington and colleagues after completion of a systematic review on exercise for falls prevention (2008). The WEBB program contains strength, balance and gait exercises, tailored to the individual based on assessment. The WEBB program is prescribed at the initial home-based intervention session, with subsequent sessions used to review and progress the exercises. Participation is defined as 'the individual's involvement in a life situation'. The individual’s participation goals are determined at baseline assessment. The goals may involve participation in the home environment (eg. able to weed the garden with spouse) or the community (eg. able to do volunteer work once per week). The environment in which the goal is set is based upon the individual's response to the Reintegration into Normal Living Index. The physiotherapist facilitates meeting of the individual’s participation goals by targeting potentially remediable barriers to the restricted participation, e.g. walking capacity, social support and community environment. In addition, the participants will be asked to complete the WEBB program daily in their own home, for one year.

Sponsors

Nicola Fairhall
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Aged>=70 years, with 3 or more Fried Frailty Criteria, not usually living in a residential aged care facility, resident in the Hornsby Ku-ring-gai local government areas, without severe cognitive impairment (defined as a Mini Mental State Examination (MMSE) score of 18 or less), absence of illnesses likely to be associated with a life expectancy of less than 12 months. Inclusion criteria is that used in the Frailty Intervention Trial (ACTRN12608000250336).

Exclusion criteria

People who did not meet all of the inclusion criteria or who did not consent. Exclusion criteria is that used in the Frailty Intervention Trial (ACTRN12608000250336).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026