Falls Prevention Evaluation and Development for Older Adults in the Community

Study Overview
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Brief Summary
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Exercise-based fall prevention programmes with strength and balance components have been shown to reduce the rate of falls, risk of falling, fractures and injuries. However, there is little evidence on the implementation of these programmes in real-world settings. This study aims to assess the effectiveness of exercise-based fall prevention interventions on fall risk (physical performance and fear of falling) among community-dwelling older adults who are at risk of falling in Singapore. A secondary aim is to assess the effectiveness of the programme on other health outcomes. The study will also evaluate the programme implementation from 3 perspectives of older adults, implementers and community partners.

Detailed Description
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Two exercise-based fall prevention programmes (Otago Exercise Programme, OEP and the Stepping On Programme, SOP) have been shown to be effective to prevent and reduce falls in primarily non-Asian settings. The Otago Exercise Programme is a single component intervention that has been shown to reduce fall rate among older adults by 35%. The OEP is a group-based exercise programme based on strength and balance components. The Stepping-On Programme is a multi-component intervention that has been shown to reduce fall rate by 30%. The SOP consists of group-based series of weekly sessions to teach fall prevention strategies to community-dwelling older adults. Sessions comprise of strength-balance exercises and classes based on adult learning principles. However, there is little evidence of the effectiveness, feasibility and acceptability of locally-adapted community fall prevention interventions. Furthermore, studies on the effectiveness of fall prevention interventions among Asian populations are less robust due to the lack of well-designed studies with adequately powered sample sizes. In this study, exercise-based fall prevention programmes will be implemented based on geographic region where participants living in the North region will receive the modified SOP and participants in the Central region will receive the modified OEP.

Official Title
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Falls Prevention Evaluation and Development for Older Adults in the Community

Conditions
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Physical Performance, Fear of Falling

Intervention / Treatment
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* Other: Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)
* Other: Wait-list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 years and above Lives in the community Living in the Central or North region of Singapore Singaporean or Singapore Permanent Resident Understand conversational English or Chinese Able to walk independently in the community with or without assistive devices (Defined as single-point walking aid, e.g. umbrella, cane, walking stick) Answered 'Yes' to any of 3 falls risk screening questions (i.e. 1. Did you have a fall in the past 12 months?, 2. Are you concerned about falling?, 3. Do you feel like you are going to fall when getting up or walking?) Exclusion Criteria: Currently participating in other falls prevention programme or trial or participated in a fall prevention programme or trial in the past 3 months Has chest pains when doing exercise Had a recent major surgery less than 3 months or is undergoing renal dialysis or active cancer treatment Has been told by a doctor to have the following medical conditions: Dementia, Severe neuromuscular or cardiovascular conditions i.e. stroke in the past 6 months, heart failure, acute myocardial infarction, Parkinson's disease Have been told by a doctor not to exercise due to health issues Score of less than 7 on the Abbreviated Mental Test (AMT)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This is a stepped-wedge cluster randomized trial in which there will be a sequential crossover of clusters from the waitlist control to the intervention period where the sequence of crossover is randomized. The clusters are defined as groups with at least 5 participants. Each of the North and Central regions will have 6 clusters. The intervention will be sequentially rolled out to 12 clusters that are randomized to 6 time periods (sequences). Each sequence has 6 steps where one step has a duration of 8 weeks. The intervention will be rolled out sequentially to 2 clusters (1 North, 1 Central) at every step until all 12 clusters have received the intervention by the end of the study. Each cluster will have 1-3 community sites and minimum 5 participants. Outcome assessors will be blinded to sequence allocation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise-based fall prevention intervention<br>To receive 7 weeks of exercise-based programme | Other: Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)<br>* The modified OEP is a group exercise programme that consists of progressive strength and balance exercises led by trained exercise leaders (fitness instructors or health coaches). The supervised sessions will be conducted twice a week (1 hour each) for 7 weeks. Participants will be given an exercise booklet and encouraged to exercise at home. The modified SOP is a group fall prevention programme that consists of exercise sessions and discussions on various falls prevention aspects facilitated by a trained programme leader and supported by programme facilitators and peer facilitators. The supervised sessions will be conducted once a week (2 hours each) for 7 weeks. Participants will be given homework and encouraged to exercise at home. In addition, there will be an optional home visit (Week 11), a 1-hour booster session (Week 19) and a telephone call (Week 31).<br>|
| Other: Wait-list controls<br>To receive fall prevention resources while waiting for programme | Other: Wait-list control<br>* To receive fall prevention resources while waiting for their programme to start<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Mobility Between Intervention and Control Blocks | Measured using the Timed Up and Go (TUG) | Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Physical Performance Between Intervention and Control Blocks | Measured using the Short Physical Performance Battery (SPPB). A summary score (range 0-12) will be calculated, with higher score indicating a better performance. | Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis. | 
| Difference in Fear of Falling Between Intervention and Control Blocks | Measured using the 16-item Falls Efficacy Scale International (FES-I). The score ranges from 16 to 64, with a higher score indicating a greater fear of falling. | Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accidental fall, Older adult