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

October 25, 2024 updated by: Li-Ning Peng, National Yang Ming Chiao Tung University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care group
Provide conventional health educations in every three-month interval
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DHEA-S
Time Frame: baseline, 6 month
Change in DHEA-S concentration from baseline to 6 months in all participants
baseline, 6 month
Change in IGF-1
Time Frame: baseline, 6 month
Change in IGF-1 concentration from baseline to 6 months in all participants
baseline, 6 month
Change in hs-CRP
Time Frame: baseline, 6 month
Change in hs-CRP concentration from baseline to 6 months in all participants
baseline, 6 month
Change in Myostatin
Time Frame: baseline, 6 month
Change in Myostatin concentration from baseline to 6 months in all participants
baseline, 6 month
Change in Activing A
Time Frame: baseline, 6 month
Change in Activing A concentration from baseline to 6 months in all participants
baseline, 6 month
Change in Follistatin
Time Frame: baseline, 6 month
Change in Follistatin concentration from baseline to 6 months in all participants
baseline, 6 month
Change in Relative appendicular skeletal muscle index (RASM)
Time Frame: baseline, 6 month
Change in RASM from baseline to 6 months in all participants
baseline, 6 month
Change in body fat %
Time Frame: baseline, 6 month
Change in body fat % from baseline to 6 months in all participants
baseline, 6 month
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
baseline, 6 month
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
baseline, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming Chiao Tung University

Collaborators

National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Li-Ning Peng, M.D., PhD, Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NYCU112162AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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