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Completed

NCT Number: 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Geriatrics and Gerontology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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