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RecruitingNCT06660706Updated Oct 28, 2024

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

An interventional study of Multi-domain intervention in Age-related Functional Decline, sponsored by National Yang Ming Chiao Tung University. Recruiting at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Apr 2024, registered Oct 2024).
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Age-related Functional Decline

Keywords

  • aging
  • muscle health
  • body composition
03

In context

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Multidomain intervention group

    The multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week.

    Behavioral: Multi-domain intervention

  • No intervention
    Usual care group

    Provide conventional health educations in every three-month interval

Interventions

  • BehavioralMulti-domain intervention

    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

06

What researchers measure

Primary outcomes

  1. Change in Physical performance

    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

    Time frame: baseline, 6 month

Secondary outcomes

  1. Change in DHEA-S

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

    Time frame: baseline, 6 month

  2. Change in IGF-1

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

    Time frame: baseline, 6 month

  3. Change in hs-CRP

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

    Time frame: baseline, 6 month

  4. Change in Myostatin

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

    Time frame: baseline, 6 month

  5. Change in Activing A

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

    Time frame: baseline, 6 month

  6. Change in Follistatin

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

    Time frame: baseline, 6 month

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

    Change in RASM from baseline to 6 months in all participants

    Time frame: baseline, 6 month

  8. Change in body fat %

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

    Time frame: baseline, 6 month

  9. Change in Cognitive performance

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

    Time frame: baseline, 6 month

  10. Change from lipoproflie

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

    Time frame: baseline, 6 month

07

Study locations

1 of 1 sites recruiting
  • Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
    Taipei, 112, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06660706
Lead sponsor
National Yang Ming Chiao Tung University
Collaborators
National Health Research Institutes, Taiwan
Responsible party
Li-Ning Peng (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Oct 28, 2024
Start date
Apr 1, 2024
Primary completion
Jun 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 28, 2024

Study contacts

Li-Ning Peng, M.D., PhD
Contact
lining.peng@gmail.com
+886-28239014
Li-Ning Peng, M.D., PhD
principal investigator · Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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