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Trial registered on ANZCTR

Registration number

ACTRN12610000862044

Ethics application status

Approved

Date submitted

8/10/2010

Date registered

14/10/2010

Date last updated

14/10/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of participation restriction in trials of exercise interventions to prevent falls in older people: A systematic review and meta-analysis.

Scientific title

Evaluation of participation restriction in trials of exercise interventions to prevent falls in older people: A systematic review and meta-analysis.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Participation restriction in older people.

Falls prevention in older people

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

No intervention.

The systematic review aims to evaluate the extent to which measurement of participation has been reported in randomised controlled trials of fall prevention interventions that contain exercise.

The meta-analysis consists of trials that measured participation at baseline and follow-up. The meta-analysis aims to determine whether exercise interventions targeting falls increase International Classification of Functioning, Disability and Health (ICF) participation in older people.

The systematic review and meta-analysis will include randomised controlled trials which include an exercise intervention of any duration. Exercise is defined as an intervention meeting the Prevention of Falls Network Europe (ProFaNE) category of exercise (supervised or unsupervised). (ProFaNE subcategories are gait, balance, co-ordination, functional tasks, strength/resistance, flexibility, 3D (tai chi, qui Gong, dance, yoga), general physical activity, endurance, other kinds of exercises. Exercise may be delivered either in isolation or as a component of a multifactorial intervention or a multiple intervention.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Intervention code [3]

Behaviour

Comparator / control treatment

The effects of the intervention will be compared with placebo, alternate therapy (e.g. falls eduction program, acupuncture) or usual care.

Control group

Active

Outcomes

Primary outcome [1]

To evaluate the proportion of falls prevention trials, with an exercise intervention, that have measured participation outcomes.

*Participation is defined in the International Classification of Functioning, Disability and Health (ICF) as "involvement in life roles".

Method for identifying measures of participation:
For each included study, all reported outcome measures will be collected on a data extraction form. Measurement instruments potentially measuring the ICF category of participation will be identified if they were designed to measure the societal consequences of health conditions, health related quality of life or generic health. Copies of all measurement instruments potentially measuring participation will be acquired. The instruments items will be linked to the ICF using established linking rules.(1) In order to determine if the ICF concept of participation is measured, the instruments will be assessed against the following instrument selection criteria.(2,3): 1) inclusion of at least three domains from chapters 3-9 of the activities and participation sections of the ICF; 2) designed for community use. Instruments meeting these criteria for participation will be included if they were self or interview administered, generic and constructed for adults. The use of ICF terminology is not essential. In addition to instruments developed to address the concept of participation, instruments developed using related conceptual models (eg. handicap, community integration) will be included if they meet the inclusion criteria. Instruments will be classified as health-status instruments if they contained multiple ICF concepts, such as the EuroQol (EQ-5D), SF-12 and World Health Organization Disability Assessment Schedule II (WHODAS II).

(1) Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustun B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005 Jul;37(4):212-8.
(2) Noonan VK, Kopec JA, Noreau L, Singer J, Dvorak MF. A review of participation instruments based on the International Classification of Functioning, Disability and Health. Disabil Rehabil. 2009;31(23):1883-901.
(3) Noonan VK, Kopec JA, Noreau L, Singer J, Chan A, Masse LC, et al. Comparing the content of participation instruments using the international classification of functioning, disability and health. Health Qual Life Outcomes. 2009;7:93.

Timepoint [1]

Data collected at baseline in the individual trials. Data will be analysed at the conclusion of this systematic review.

Primary outcome [2]

Use meta-analysis to evaluate whether exercise interventions targeting falls increase participation in older people.

Timepoint [2]

Data collected at baseline and the first time point after the conclusion of the intervention in the individual trials.

If a trial reports results of more than one participation outcome, only one outcome will be included in the meta-analysis, with measures incorporating the individual's perception of their participation prioritised over measures assessing frequency of activities.

We will record either the pre and post mean and standard deviation scores, the mean and standard deviation change from baseline scores or the raw scores. The standardised mean difference with 95% confidence interval will be calculated.

Secondary outcome [1]

To determine which measurement instruments are used to measure participation in falls prevention trials that include an exercise intervention.

Timepoint [1]

Data collected at baseline in the individual trials. Data will be analysed at the conclusion of this systematic review.

Secondary outcome [2]

To assess the association between type of intervention (exercise only or multi-faceted / multifactorial with an exercise component) and estimates of the effect of intervention on participation.

Timepoint [2]

Data collected at baseline and the first time point after the conclusion of the intervention in the individual trials. Data will be analysed using meta-regression analysis at the conclusion of this systematic review.

Eligibility

Key inclusion criteria

For the systematic review:
- Randomised controlled trials and quasi-randomised trials.
- Studies that specify participants were aged 60 years or over; studies that clearly recruited participants described as older people, elderly or senior; or in the case of trials including younger participants with a specific diagnosis (e.g. stroke), participants had a mean age minus one standard deviation of over 60 years.
- Studies with interventions that include exercise, delivered either in isolation or as a component of a multifactorial intervention or a multiple intervention.
- Studies that report outcome measures that evaluate number of falls, rate of falls or number of fallers.

For the meta-analysis:
- Trials that measured participation at baseline and at least one time point after conclusion of the intervention.

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Studies published only in abstract form
Studies referring people to an exercise program

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Nicola Fairhall

Address

The George Institute for Global Health, PO Box M201, Missenden Road Sydney NSW 2050

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr. Catherine Sherrington

Address [1]

The George Institute for Global Health, PO Box M201, Missenden Road Sydney NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Individual trial ethics committees

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Participation, as defined by the International Classification of Functioning, Disability and Health, reflects the societal consequences of health conditions. Despite being a key component of functioning and an important goal of rehabilitation, participation is not measured consistently in ageing research. 
Falls are a major public health problem. Fortunately, well-designed exercise interventions have been shown to reduce falls in older people. To date, evaluation of these interventions has focused on rate of falls, impairment of body function and performance of tasks. The consequence of falls prevention programs on functioning at a societal level have not been evaluated. Increased understanding of how falls prevention interventions affect participation may provide opportunities to enhance outcomes for people at risk of falling. 

The objectives of this study are to:
- Evaluate the extent to which measurement of participation has been reported in trials of fall prevention interventions with an exercise component.
- Determine whether exercise interventions targeting falls increase ICF participation in older people.

We will undertake a systematic review with meta-analysis of randomised controlled trials of interventions including exercise that aimed to reduce falls in older people in the community, aged care facilities or hospital. 

Studies will be extracted from the Cochrane Review of interventions for preventing falls in older people living in the community(1) and the Cochrane Review of interventions for preventing falls in older people in nursing care facilities and hospitals.(2) We will re-run the search strategies used in these Cochrane Reviews in Medline, EMBASE, AMED, PsychINFO, CINAHL and CENTRAL. The original Cochrane Reviews searched CINAHL via the Ovid platform. As this is no longer available, CINAHL will be accessed via EBESCO. The searches will run from the final date searched by Gillespie et al(1) and Cameron et al,(2) to May 2010. Language restrictions will not be applied.

Measurement instruments used in the trials will be linked to the ICF then assessed against instrument classification criteria, to determine whether they measure participation. Trials with published participation data at baseline and at least one follow-up time-point will be included in the meta-analysis.

In order to minimise bias, the following methods will be used:
- Study selection. One author will independently examine the titles, abstracts and keywords to identify potentially relevant trials from the search results. Full text reports will be obtained for all potentially eligible studies. Based on the full text reports, two authors will independently decide on study inclusion. Differences will be resolved by discussion or, if necessary, arbitrated by an independent third author. Details of discussions will be kept.
- Data extraction. Data regarding trial characteristics and estimates of effect of the intervention will be extracted from the included trials by one author and checked by a second author. Disagreement will be resolved by discussion or, if necessary, arbitration by third author.
- Duplicate publication bias will be avoided by comparing author names, sample sizes, interventions and outcomes. 
- Publication bias will be assessed using Egger’s test and observation of the funnel plot. 
- Assessment of bias of included studies. Two authors will independently assess risk of bias using the Cochrane risk of bias tool, outlined in the Cochrane Handbook for Systematic Reviews of Interventions. Bias will be considered from the study level (assessment of sequence generation and adequacy of allocation concealment) and also the outcome level (evaluation of the methods used to measure the participation outcome in each study: blinding of outcome assessors, completeness of participation data and selective reporting of participation data). Any disagreement will be resolved by consensus or third-party arbitration.

(1) Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, et al. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009(2):CD007146.
(2) Cameron ID, Murray GR, Gillespie LD, Robertson MC, Hill KD, Cumming RG, et al. Interventions for preventing falls in older people in nursing care facilities and hospitals. Cochrane Database Syst Rev. 2010(1):CD005465.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Nicola Fairhall

Address

The George Institute for Global Health, PO Box M201, Missenden Road Sydney NSW 2050

Country

Australia

Phone

+61 2 8238 2408

Fax

nfairhall@georgeinstitute.org.au

Contact person for scientific queries

Name

Nicola Fairhall

Address

The George Institute for Global Health, PO Box M201, Missenden Road Sydney NSW 2050

Country

Australia

Phone

+61 2 8238 2408

Fax

nfairhall@georgeinstitute.org.au

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

No additional documents have been identified.

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