Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000507381
Ethics application status
Approved
Date submitted
7/09/2008
Date registered
30/09/2008
Date last updated
30/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increasing participation. A sub-study of the Frailty Intervention Trial (FIT).
Scientific title
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.
Secondary ID [1] 288032 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 3603 0
Disability 3604 0
Chronic health conditions associated with ageing 3605 0
Undernutrition 3606 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3764 3764 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3320 0
Rehabilitation
Comparator / control treatment
Usual care for the duration on one year. Usual care is a combination of aged care and health services that are routinely provided.
Control group
Active

Outcomes
Primary outcome [1] 4658 0
Reintegration into Normal Living Index
Timepoint [1] 4658 0
At baseline, three and 12 months after randomisation.
Primary outcome [2] 4659 0
Goal Attainment Scale
Timepoint [2] 4659 0
At baseline, three and 12 months after randomisation.
Primary outcome [3] 4660 0
Life Space Assessment. Measures mobility in terms of the spatial extent of a person's life.
Timepoint [3] 4660 0
At baseline, three and 12 months after randomisation.
Secondary outcome [1] 7873 0
Question: 'Do you get out as much as you would like?'
Timepoint [1] 7873 0
At baseline, three and 12 months after randomisation.
Secondary outcome [2] 7874 0
Maximal muscle strength of knee extensors, measured using a kilo force measuring guage attached to the subjects leg and the back of the chair in which they are seated.
Timepoint [2] 7874 0
At baseline, three and 12 months after randomisation.
Secondary outcome [3] 7875 0
Timed four-meter walk test
Timepoint [3] 7875 0
At baseline, three and 12 months after randomisation.
Secondary outcome [4] 7876 0
Activity Measure for Post Acute Care
Timepoint [4] 7876 0
At baseline, three and 12 months after randomisation.
Secondary outcome [5] 7877 0
Nottingham Extended Activities of Daily Living Index
Timepoint [5] 7877 0
At baseline, three and 12 months after randomisation.

Eligibility
Key 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).
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As per Frailty Intervention Trial (ACTRN12608000250336). The research consultant screens for inclusion criteria. If the person satisfies criteria the study nurse then telephones the research program manager for treatment allocation (until this point the study nurse is blinded to the treatment allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As per Frailty Intervention Trial (ACTRN12608000250336). Permuted block randomisation is used to achieve balanced treatment allocation. There are two strata (frail with 3 frailty criteria and very frail with 4 or 5 frailty criteria). A random number sequence was generated for the order of treatment allocation within the blocks using SPSS v15 RV.UNIFORM function. Varying block sizes were used. The blocks were randomly arranged within larger sized blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2008
Actual
15/01/2008
Date of last participant enrolment
Anticipated
Actual
15/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
241
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4796 0
Hornsby Ku-ring-gai Hospital - Hornsby

Funding & Sponsors
Funding source category [1] 3779 0
Government body
Name [1] 3779 0
National Health and Medical Research Council
Country [1] 3779 0
Australia
Primary sponsor type
Individual
Name
Nicola Fairhall
Address
The George Institute for International Health, PO Box M201, Missenden Road Sydney NSW 2050
Country
Australia
Secondary sponsor category [1] 3389 0
Individual
Name [1] 3389 0
Professor Ian Cameron
Address [1] 3389 0
Royal Rehabilitation Center Sydney, Rehabilitation Studies Unit, PO Box 6 Ryde NSW 1680
Country [1] 3389 0
Australia
Secondary sponsor category [2] 3390 0
Individual
Name [2] 3390 0
Dr Cathie Sherrington
Address [2] 3390 0
The George Institute for International Health, PO Box M201, Missenden Road Sydney NSW 2050
Country [2] 3390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5841 0
Harbour HREC Northern Sydney Central Coast Health
Ethics committee address [1] 5841 0
The Reserach Office, Level 4, Vindin House, Royal North Shore Hospital, St Leonards NSW 2065
Ethics committee country [1] 5841 0
Australia
Date submitted for ethics approval [1] 5841 0
Approval date [1] 5841 0
20/08/2008
Ethics approval number [1] 5841 0
0808-160M(SP)

Summary
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.
Trial website
This is a sub-study of the Frailty Intervention Trial (FIT), ACTRN12608000250336. The FIT website is http://www.rehab.med.usyd.edu.au/tie/fit
Trial related presentations / publications
Fairhall N, Sherrington C S, Lord SR, Kurrle SE, Lockwood K, Cameron ID. Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial. BMC Medicine. 2012, 10:120
Public notes

Contacts
Principal investigator
Name 28874 0
Dr Nicola Fairhall
Address 28874 0
The George Institute for International Health, PO Box M201, Missenden Road Sydney NSW 2050
Country 28874 0
Australia
Phone 28874 0
+61400303626
Fax 28874 0
Email 28874 0
[email protected]
Contact person for public queries
Name 12031 0
Nicola Fairhall
Address 12031 0
The George Institute for International Health, PO Box M201, Missenden Road Sydney NSW 2050
Country 12031 0
Australia
Phone 12031 0
+61 2 82382411
Fax 12031 0
Email 12031 0
[email protected]
Contact person for scientific queries
Name 2959 0
Nicola Fairhall
Address 2959 0
The George Institute for International Health, PO Box M201, Missenden Road Sydney NSW 2050
Country 2959 0
Australia
Phone 2959 0
+61 2 82382411
Fax 2959 0
Email 2959 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial.2012https://dx.doi.org/10.1186/1741-7015-10-120
N.B. These documents automatically identified may not have been verified by the study sponsor.