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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04788251
Other study ID # 2020/01193
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2021
Est. completion date October 29, 2022

Study information

Verified date May 2023
Source Geriatric Education and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 29, 2022
Est. primary completion date October 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 99 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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).
Wait-list control
To receive fall prevention resources while waiting for their programme to start

Locations

Country Name City State
Singapore Khoo Teck Puat Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore

Sponsors (7)

Lead Sponsor Collaborator
Geriatric Education and Research Institute Duke-NUS Graduate Medical School, Khoo Teck Puat Hospital, Ministry of Health, Singapore, Monash University, Singapore Institute of Technology, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Other Falls and Injurious Falls Number of falls, rate of falls and number of fall-related injuries will be measured as secondary outcomes. Fall-related health utilization in terms of hospitalization or institutionalization will also be measured. Data will be collected at baseline and immediately after each step
Other Subjective Health Measured by asking "In general, how would you say your health is?" Data will be collected at baseline and immediately after each step
Other Health-Related Quality of Life Measured using the 5-level EuroQol 5-dimension (EQ-5D-5L) scales. It will be used to assess health-related quality of life in 5 dimensions, whereby each dimensions will be scored on a 5-point rating scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. Scores will be combined and converted to a single index value. Data will be collected at baseline and immediately after each step
Other Fall-Related Protective Behaviours Measured using the revised Falls Behavioural Scale (FaB) that includes 24 statements that describe day-to-day behaviours and actions, both habitual and intentional, that if not done safely, can place an individual at undue risk of falling. Participants will respond with a four-point Likert scale. Higher score indicates safer behaviours. Data will be collected immediately pre- and post-intervention
Other Loneliness Measured using the revised UCLA 3-item Loneliness Scale. The score ranges from 3 to 9, with people from 3-5 as 'not lonely' and people score 6-9 as 'lonely'. Data will be collected at baseline and immediately after each step
Other Falls-Related Healthcare Utilization Cost Measured using the Client Service Receipt Inventory (CSRI) Data will be collected at baseline and immediately after each step
Other Productivity Loss Measured using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) Data will be collected at baseline and immediately after each step
Primary 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 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.
Secondary 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.
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