Physical Performance Clinical Trial
— FREDAOfficial title:
Falls Prevention Evaluation and Development for Older Adults in the Community
Verified date | May 2023 |
Source | Geriatric Education and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Singapore | Khoo Teck Puat Hospital | Singapore | |
Singapore | Tan Tock Seng Hospital | Singapore |
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 |
Singapore,
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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