- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04851262
Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
March 27, 2025 updated by: Dr. Pui-Hing Chau, The University of Hong Kong
The overall aim of the proposed project is to improve muscle strength in older adults with possible sarcopenia by promoting home-based progressive resistance exercise.
The target population for health talks is community-dwelling older adults.
A Three monthly home-visits and weekly phone calls will be made.
A waitlist randomised controlled trial will be conducted to evaluate effectiveness, and qualitative feedback will be collected from participants.
A pilot study will be conducted first.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
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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Hong Kong, Hong Kong
- Community
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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
65 years to 89 years (Older Adult)
Accepts Healthy Volunteers
Yes
Description
The inclusion criteria are:
- Aged 65-89;
- Possible sarcopenia (defined by AWGS 2019);
- No cognitive impairment (Abbreviated Mental Test score ≥8); and
- No communication problems.
The exclusion criteria are:
- having engaged in a structured exercise programme in the past 6 months or planning to do so within the intervention period;
- mobility-limiting injury of the hands or lower limbs, surgery or hospitalisation within the intervention period;
- contraindications such as musculoskeletal/cardiorespiratory disorders, or any advanced diseases that inhibit them from exercising.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
The intervention is a 12-week home-based resistance training programme with phased progression.
The intervention will have three phases: (i) an initial phase focused on training the target muscle(s)/movements with minimal or no external weight; (ii) an intermediate phase targeting muscle strength with increased practice resistance; and (iii) an advanced phase targeting the further enhancement of muscle strength by challenging multiple muscle groups.
Each phase will involve exercises targeting the trunk, back, hip, upper-limb and lower-limb muscles.
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The intervention is to be taught by fitness trainer at the participants' home at the start of each phase.
The exercise progression model for older adults recommended by the American College of Sports Medicine, which emphasise gradual increments in training load and systematically alter one or more programme components, will be adopted.
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Other: Waitlist control
The waitlist control participants will start the intervention 12 weeks after the baseline assessment.
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The intervention is to be taught by fitness trainer at the participants' home at the start of each phase.
The exercise progression model for older adults recommended by the American College of Sports Medicine, which emphasise gradual increments in training load and systematically alter one or more programme components, will be adopted.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in lower-limb muscle strength at 12 weeks from baseline
Time Frame: 12 weeks after baseline
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Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
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12 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lower-limb muscle strength at 24 weeks from baseline
Time Frame: 24 weeks after baseline
|
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
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24 weeks after baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in handgrip strength at 12 weeks from baseline
Time Frame: 12 weeks after baseline
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Measured by a spring-type dynamometer, higher value indicates better performance
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12 weeks after baseline
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Change in handgrip strength at 24 weeks from baseline
Time Frame: 24 weeks after baseline
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Measured by a spring-type dynamometer, higher value indicates better performance
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24 weeks after baseline
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Status of possible sarcopenia at 12 weeks from baseline
Time Frame: 12 weeks after baseline
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Indicated by 5-time chair stand test ≥12 second, or men and women with <28 kg and <18 kg strength
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12 weeks after baseline
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Status of possible sarcopenia at 24 weeks from baseline
Time Frame: 24 weeks after baseline
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Indicated by 5-time chair stand test ≥12 second, or men and women with <28 kg and <18 kg strength
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24 weeks after baseline
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Sarcopenia risk score at 12 weeks from baseline
Time Frame: 12 weeks after baseline
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Measured by SARC-CalF, which is a combination of SARC-F questionnaire and calf circumference, a cut of of >=11 indicates high risk
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12 weeks after baseline
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Sarcopenia risk score at 24weeks from baseline
Time Frame: 24 weeks after baseline
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Measured by SARC-CalF, which is a combination of SARC-F questionnaire and calf circumference, a cut of of >=11 indicates high risk
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24 weeks after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2021
Primary Completion (Actual)
November 7, 2024
Study Completion (Actual)
November 7, 2024
Study Registration Dates
First Submitted
April 12, 2021
First Submitted That Met QC Criteria
April 19, 2021
First Posted (Actual)
April 20, 2021
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 27, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW20-868
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
To protect confidentiality of participants.
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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