- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438876
The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore
February 8, 2021 updated by: Geriatric Education and Research Institute
The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore: A Randomised Controlled Trial
To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail and frail community-dwelling older adults in Singapore for the management of physical frailty.
The proposed study will provide information on the benefits of FPT on physical performances of older adults and help to shape future exercise recommendations to slow or reverse the onset and severity of physical frailty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Singapore, Singapore
- Geriatric Education & Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 55 years and above
- low muscle strength - handgrip strength less than 26kg for men and 18kg for women
- ambulate without human assistance
- able to understand basic instructions
Exclusion Criteria:
- currently enrolled in another study
- acute musculoskeletal injury
- unable to participate in the full duration of the study
- unwilling to participate if not assigned to the intervention group
- deemed not suitable to participate in exercise by a medical doctor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Function power training
12-week structured FPT program, conducted by a certified trainer from a community service provider.
Sessions were held twice weekly at the respective community senior activity centers, each lasting 60 minutes in duration.
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The exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance.
Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises.
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Active Comparator: Usual care
Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
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Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Frail status at 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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Cardiovascular Health Study (CHS) Frailty status which characterizes frailty based on five components: unintentional weight loss, weakness, slowness, exhaustion and low physical activity.
1 point for each category.
Robust: 0 point, Pre-Frail: 1-2 points , Frail: 3-5 points.
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baseline, 12 weeks, 24 weeks
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Change of hand grip strength at 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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Hand grip strength (kg)
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baseline, 12 weeks, 24 weeks
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Change of knee extensor strength at 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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Knee extensor strength (kg)
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baseline, 12 weeks, 24 weeks
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Change of Timed up and go (TUG) at 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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Timed up and go (TUG) (seconds)
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baseline, 12 weeks, 24 weeks
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Change of SPPB at 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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Short Physical Performance Battery (SPPB) consist of:
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baseline, 12 weeks, 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise adherence
Time Frame: baseline, 12 weeks, 24 weeks
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Exercise journals
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baseline, 12 weeks, 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shiou-Liang Wee, PhD, Geriatric Education & Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2019
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 15, 2020
First Submitted That Met QC Criteria
June 17, 2020
First Posted (Actual)
June 19, 2020
Study Record Updates
Last Update Posted (Actual)
February 9, 2021
Last Update Submitted That Met QC Criteria
February 8, 2021
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GERI1618
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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