Clinical trial NCT04788251: Falls Prevention Evaluation and Development for Older Adults in the Community
Official title: Falls Prevention Evaluation and Development for Older Adults in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Fear of Falling
Keywords: Accidental fall
Older adult
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Singapore
name: Tan Tock Seng Hospital
name: Khoo Teck Puat Hospital
name: Singapore Institute of Technology
name: Duke-NUS Graduate Medical School
name: Monash University
First posted: 2021-03-09
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference in Mobility Between Intervention and Control Blocks
timeFrame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Secondary outcomes:
measure: Difference in Physical Performance Between Intervention and Control Blocks
timeFrame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
measure: Difference in Fear of Falling Between Intervention and Control Blocks
timeFrame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Other outcomes:
measure: Falls and Injurious Falls
timeFrame: Data will be collected at baseline and immediately after each step
measure: Subjective Health
timeFrame: Data will be collected at baseline and immediately after each step
measure: Health-Related Quality of Life
timeFrame: Data will be collected at baseline and immediately after each step
measure: Fall-Related Protective Behaviours
timeFrame: Data will be collected immediately pre- and post-intervention
measure: Loneliness
timeFrame: Data will be collected at baseline and immediately after each step
measure: Falls-Related Healthcare Utilization Cost
timeFrame: Data will be collected at baseline and immediately after each step
measure: Productivity Loss
timeFrame: Data will be collected at baseline and immediately after each step
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
Study officials:
affiliation: Geriatric Education and Research Institute
name: Chek Hooi Wong, MBBS, FRCP, MPH
role: PRINCIPAL_INVESTIGATOR
References: