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Recruiting NCT06660706

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

No phase Interventional Age-related Functional Decline

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-domain intervention.
Who it may be relevant to
Registry conditions: Age-related Functional Decline. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Change in Physical performance [Time frame: baseline, 6 month]
Secondary outcome measures (10)
  • Change in DHEA-S [Time frame: baseline, 6 month]
  • Change in IGF-1 [Time frame: baseline, 6 month]
  • Change in hs-CRP [Time frame: baseline, 6 month]
  • Change in Myostatin [Time frame: baseline, 6 month]
  • Change in Activing A [Time frame: baseline, 6 month]
  • Change in Follistatin [Time frame: baseline, 6 month]
  • Change in Relative appendicular skeletal muscle index (RASM) [Time frame: baseline, 6 month]
  • Change in body fat % [Time frame: baseline, 6 month]
  • Change in Cognitive performance [Time frame: baseline, 6 month]
  • Change from lipoproflie [Time frame: baseline, 6 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University — Taipei

Identifiers

NCT: NCT06660706 · NYCU112162AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗