Falls Prevention Evaluation and Development for Older Adults in the Community

Physical Performance Clinical Trial

— FREDA  

Official title:

Falls Prevention Evaluation and Development for Older Adults in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788251
• Other study ID #: 2020/01193
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Fear of Falling
• Physical Performance

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.