Falls Prevention Evaluation and Development for Older Adults in the Community

NCT04788251 | Completed DMC

• 1 other identifier: 2020/01193
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Physical Performance; Fear of Falling

Keywords

Accidental fall; Older adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in Physical Performance Between Intervention and Control Blocks

  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

  Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.

Other Outcomes (7)

• Falls and Injurious Falls

  Data will be collected at baseline and immediately after each step

• Subjective Health

  Data will be collected at baseline and immediately after each step

• Health-Related Quality of Life

  Data will be collected at baseline and immediately after each step

Study Arms (2)

Exercise-based fall prevention intervention

EXPERIMENTAL

To receive 7 weeks of exercise-based programme

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

Wait-list controls

OTHER

To receive fall prevention resources while waiting for programme

Other: Wait-list control

Interventions

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

Exercise-based fall prevention intervention

Wait-list control OTHER

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

Wait-list controls

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Geriatric Education and Research Institute: lead
• Ministry of Health, Singapore: collaborator
• Tan Tock Seng Hospital: collaborator
• Khoo Teck Puat Hospital: collaborator
• Singapore Institute of Technology: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Monash University: collaborator

Study Sites (2)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (1)

• 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.

  PMID: 37263684 DERIVED

Study Officials

• Chek Hooi Wong, MBBS, FRCP, MPH

  Geriatric Education and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: March 9, 2021
• Study Start: September 21, 2021
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)