Clinical trial NCT06660706: The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers
Official title: The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Functional Decline
Keywords: aging
muscle health
body composition
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2024-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change in Physical performance
timeFrame: baseline, 6 month
Secondary outcomes:
measure: Change in DHEA-S
timeFrame: baseline, 6 month
measure: Change in IGF-1
timeFrame: baseline, 6 month
measure: Change in hs-CRP
timeFrame: baseline, 6 month
measure: Change in Myostatin
timeFrame: baseline, 6 month
measure: Change in Activing A
timeFrame: baseline, 6 month
measure: Change in Follistatin
timeFrame: baseline, 6 month
measure: Change in Relative appendicular skeletal muscle index (RASM)
timeFrame: baseline, 6 month
measure: Change in body fat %
timeFrame: baseline, 6 month
measure: Change in Cognitive performance
timeFrame: baseline, 6 month
measure: Change from lipoproflie
timeFrame: baseline, 6 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
Study officials:
affiliation: Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
name: Li-Ning Peng, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: