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NCT Number: NCT06660706

The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers

This project aims to investigate the intricate interplay between skeletal muscle and adipose tissue during the aging process by integrating human studies. Utilizing interventional research and randomized trials combined with examining blood samples from elderly individuals engaged in exercise, we aim to investigate the effects of exercise on muscle health and explore the underlying mechanisms of muscle aging and related biomarkers. Interdisciplinary research allowed us to investigate the systemic impact of exercise on muscles. This approach allowed us to gain a better understanding of the interconnectedness of skeletal muscle and adipose tissue in the aging process and devise efficient strategies to reverse age-related changes. These findings hold promise for promoting a future society where long and healthy life is achievable for all.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Li-Ning Peng, M.D., PhD

CONTACT

[email protected]

+886-28239014

About this study

This study is a randomized controlled trial of 6-month multidomain intervention program among community-living older adults with early physical impairments.

Inclusion criteria

are: (1) community-dwelling adults aged ≥ 65 years, (2) slow gait speed (<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength <28 kg in men, <18 kg in women); subjects with the following conditions will be excluded: (1) established diagnosis of dementia, Parkinsonism or other neurodegenerative disease (2) disable status: mobilitylimiting conditions, (3) active, acute diseases receiving treatment, such as cancer, heart failure, COPD and so on, (4) estimated life expectancy <12 months, (5) current nursing home residents.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged ≥ 65 years
  • slow gait speed (<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength <28 kg in men, <18 kg in women)

Exclusion criteria

  • established diagnosis of dementia, Parkinsonism or other mobility-limiting, disable conditions
  • active, acute diseases receiving treatment, such as cancer, heart failure, COPD and so on
  • estimated life expectancy <12 months
  • current nursing home residents

Treatment and study plan

Multi-domain intervention

Behavioral

Each session comprises of 45 minutes physical fitness activities targeting on muscle strength, balance, and flexibility; 1-hour cognitive training primarily on reasoning and memory exercises; and 15-minute for nutritional advices based on national diet guidelines for older adults

Primary outcomes

  1. Change in Physical performance

    Time frame: baseline, 6 month

    Change in hand-grip strength (kg), or six-meter walking speed (m/s), or 5 times sit to stand test from baseline to 6 months in all participants

Secondary outcomes

  1. Change in DHEA-S

    Time frame: baseline, 6 month

    Change in DHEA-S concentration from baseline to 6 months in all participants

  2. Change in IGF-1

    Time frame: baseline, 6 month

    Change in IGF-1 concentration from baseline to 6 months in all participants

  3. Change in hs-CRP

    Time frame: baseline, 6 month

    Change in hs-CRP concentration from baseline to 6 months in all participants

  4. Change in Myostatin

    Time frame: baseline, 6 month

    Change in Myostatin concentration from baseline to 6 months in all participants

  5. Change in Activing A

    Time frame: baseline, 6 month

    Change in Activing A concentration from baseline to 6 months in all participants

  6. Change in Follistatin

    Time frame: baseline, 6 month

    Change in Follistatin concentration from baseline to 6 months in all participants

  7. Change in Relative appendicular skeletal muscle index (RASM)

    Time frame: baseline, 6 month

    Change in RASM from baseline to 6 months in all participants

  8. Change in body fat %

    Time frame: baseline, 6 month

    Change in body fat % from baseline to 6 months in all participants

  9. Change in Cognitive performance

    Time frame: baseline, 6 month

    Change in Montreal Cognitive Assessment (MoCA), or Mini-mental state examination (MMSE) from baseline to 6months in all participants

  10. Change from lipoproflie

    Time frame: baseline, 6 month

    Change in Total Cholesterol, Triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol from baseline to 6months in all participants

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Ning Peng, M.D., PhD

CONTACT

[email protected]

+886-28239014

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • National Health Research Institutes, Taiwan

Registry information

Important dates

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

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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