Falls Prevention Evaluation and Development for Older Adults in the Community

NCT ID: NCT04788251

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2022-10-29

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.

Conditions

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Physical Performance Fear of Falling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise-based fall prevention intervention

To receive 7 weeks of exercise-based programme

Group Type EXPERIMENTAL

Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)

Intervention Type OTHER

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).

Wait-list controls

To receive fall prevention resources while waiting for programme

Group Type OTHER

Wait-list control

Intervention Type OTHER

To receive fall prevention resources while waiting for their programme to start

Interventions

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Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)

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).

Intervention Type OTHER

Wait-list control

To receive fall prevention resources while waiting for their programme to start

Intervention Type OTHER

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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Singapore

OTHER_GOV

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

Khoo Teck Puat Hospital

OTHER

Sponsor Role collaborator

Singapore Institute of Technology

OTHER

Sponsor Role collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

Geriatric Education and Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chek Hooi Wong, MBBS, FRCP, MPH

Role: PRINCIPAL_INVESTIGATOR

Geriatric Education and Research Institute

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Khoo Teck Puat Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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Tan PJ, Ginting ML, Lim ZZB, Balachandar N, Sultana R, Kadir MM, Xu T, Ismail NH, Yap JKY, Wong SF, Yoong J, Matchar DB, Hill K, Wong CH. Pragmatic multicentre stepped-wedge cluster randomised trial to investigate the effectiveness of community-based falls prevention programme for older adults with falls risk in Singapore: a protocol paper. BMJ Open. 2023 Jun 1;13(6):e072029. doi: 10.1136/bmjopen-2023-072029.

Reference Type DERIVED
PMID: 37263684 (View on PubMed)

Other Identifiers

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2020/01193

Identifier Type: -

Identifier Source: org_study_id

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