Back to resultsHome-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
Primary Purpose
Sarcopenia
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia
Eligibility Criteria
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.
Sites / Locations
- Community
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Waitlist control
Arm Description
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.
The waitlist control participants will start the intervention 12 weeks after the baseline assessment.
Outcomes
Primary Outcome Measures
Change in lower-limb muscle strength at 12 weeks from baseline
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
Secondary Outcome Measures
Change in lower-limb muscle strength at 24 weeks from baseline
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
Full Information
NCT ID
NCT04851262
First Posted
April 12, 2021
Last Updated
October 31, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04851262
Brief Title
Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
Official Title
Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
The waitlist control participants will start the intervention 12 weeks after the baseline assessment.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in lower-limb muscle strength at 12 weeks from baseline
Description
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
Time Frame
12 weeks after baseline
Secondary Outcome Measure Information:
Title
Change in lower-limb muscle strength at 24 weeks from baseline
Description
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
Time Frame
24 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Change in handgrip strength at 12 weeks from baseline
Description
Measured by a spring-type dynamometer, higher value indicates better performance
Time Frame
12 weeks after baseline
Title
Change in handgrip strength at 24 weeks from baseline
Description
Measured by a spring-type dynamometer, higher value indicates better performance
Time Frame
24 weeks after baseline
Title
Status of possible sarcopenia at 12 weeks from baseline
Description
Indicated by 5-time chair stand test ≥12 second, or men and women with <28 kg and <18 kg strength
Time Frame
12 weeks after baseline
Title
Status of possible sarcopenia at 24 weeks from baseline
Description
Indicated by 5-time chair stand test ≥12 second, or men and women with <28 kg and <18 kg strength
Time Frame
24 weeks after baseline
Title
Sarcopenia risk score at 12 weeks from baseline
Description
Measured by SARC-CalF, which is a combination of SARC-F questionnaire and calf circumference, a cut of of >=11 indicates high risk
Time Frame
12 weeks after baseline
Title
Sarcopenia risk score at 24weeks from baseline
Description
Measured by SARC-CalF, which is a combination of SARC-F questionnaire and calf circumference, a cut of of >=11 indicates high risk
Time Frame
24 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Community
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To protect confidentiality of participants.
Learn more about this trial
Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
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