- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07554274
Assessing the Efficacy of a Muscle Strength Training Intervention for Sarcopenia in Middle-aged and Elderly Individuals
Taiwan entered an aging society in 2018 and is projected to become a super-aged society by 2025. With the increasing elderly population, age-related diseases have become an urgent issue in modern society. According to 2018 statistics from the Ministry of Health and Welfare, the prevalence of sarcopenia among individuals aged 65 and above in Taiwan is 23.6% in men and 18.6% in women. Sarcopenia is a major contributor to disability in older adults. It is characterized by age-related loss of skeletal muscle mass, decreased muscle strength, and reduced physical performance, which may lead to disability, reduced quality of life, loss of independence, and increased risk of mortality.
Previous studies have shown that appropriate nutrition and exercise can delay the onset of sarcopenia and even increase muscle mass, potentially reversing the condition. This study is an extension of the project titled "Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals". It is an interventional clinical study that recruits middle-aged and older patients with sarcopenia or pre-sarcopenia, using resistance training as the intervention. The results will be compared with the two original groups from the previous study to evaluate whether there are differences in intervention outcomes between resistance training and nutritional supplementation.
Study Overview
Detailed Description
Project Rationale:
Taiwan entered an aging society in 2018 and is projected to become a super-aged society by 2025. With the increasing elderly population, age-related diseases have become an urgent issue in modern society. According to 2018 statistics from the Ministry of Health and Welfare, the prevalence of sarcopenia among individuals aged 65 and above in Taiwan is 23.6% in men and 18.6% in women. Sarcopenia is a major contributor to disability in older adults. It is characterized by age-related loss of skeletal muscle mass, decreased muscle strength, and reduced physical performance, which may lead to disability, reduced quality of life, loss of independence, and increased risk of mortality.
Previous studies have shown that appropriate nutrition and exercise can delay the onset of sarcopenia and even increase muscle mass, potentially reversing the condition. This study is an extension of the project titled "EAssessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals." It is an interventional clinical study that recruits middle-aged and older patients with sarcopenia or pre-sarcopenia, using resistance training as the intervention. The results will be compared with the two original groups from the previous study to evaluate whether there are differences in intervention outcomes between resistance training and nutritional supplementation.
Project Objectives:
To evaluate whether there are differences in the effectiveness of resistance training and nutritional supplementation in the intervention of sarcopenia among middle-aged and older adults.
Methods:
Participants in this cohort study will be recruited from National Taiwan University Hospital. A total of 40 individuals aged 50 and above with sarcopenia or pre-sarcopenia will be enrolled. Participants will be provided with educational materials and exercise videos for resistance training, and will be encouraged to follow instructions and exercise at least twice per week. Weekly phone follow-ups will be conducted to monitor adherence and home exercise performance.
Various physiological parameters and functional fitness measures will be assessed at baseline, and the same assessments will be repeated after 8 weeks to evaluate the effectiveness of resistance training and nutritional supplementation, as well as changes in related metabolites.
Expected Outcomes:
Since pharmacological development for sarcopenia has not met expectations to date, this study will evaluate the differences between resistance training and nutritional supplementation in reducing muscle loss and improving daily functional performance in middle-aged and older adults.
Through participation in this project, staff will gain a better understanding of the pathophysiology, diagnosis, and assessment methods of sarcopenia, as well as the application of metabolomics.
This study is not expected to generate patents or commercial benefits. Any research outcomes will be jointly owned by National Taiwan University Hospital and En Chu Kong Hospital, and are planned for future academic publication.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 100
- Department of Geriatrics and Gerontology, National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 50 years
- Diagnosis of sarcopenia or pre-sarcopenia
Exclusion Criteria:
- Lack of willingness to participate
- Complete dependence on activities of daily living
- Diagnosis of cancer
- Physician-determined life expectancy of less than two years
- Deemed incapable of undergoing assessment by a physician or clinical assessor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Exercise Comparator: will be provided exercise videos for resistance training
will be provided with educational materials and exercise videos for resistance training, and will be encouraged to follow instructions and exercise at least twice per week.
Weekly phone follow-ups will be conducted to monitor adherence and home exercise performance.
|
Participants will be provided with educational materials and exercise videos for resistance training, and will be encouraged to follow instructions and exercise at least twice per week.
Weekly phone follow-ups will be conducted to monitor adherence and home exercise performance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the scale of sarcopenia
Time Frame: Baseline, 8 weeks
|
muscle strength: Use a handgrip dynamometer to measure the dominant hand grip strength (kgw) of the participants.
Take the maximum value of three measurements, with a one-minute interval between each measurement.
|
Baseline, 8 weeks
|
|
the scale of sarcopenia
Time Frame: Baseline, 8 weeks
|
physical performance: During testing, participants are required to cross their arms across their chests and record the time (seconds) taken to perform five consecutive sit-to-stand movements and their walking speed (m/s) over a distance of 6 meters.
|
Baseline, 8 weeks
|
|
the scale of sarcopenia
Time Frame: Baseline, 8 weeks
|
muscle mass: this study utilizes BIA or DXA to measure the ASMI (measuring limb muscle mass divided by height squared, kg/m^2)
|
Baseline, 8 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Ding-cheng Chan, Department of Geriatrics and Gerontology, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sarcopenia
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 202403082RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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