NCT06660706

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2024Dec 2026

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

October 25, 2024

Last Update Submit

October 25, 2024

Conditions

Keywords

agingmuscle healthbody composition

Outcome Measures

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

    baseline, 6 month

Secondary Outcomes (10)

  • Change in DHEA-S

    baseline, 6 month

  • Change in IGF-1

    baseline, 6 month

  • Change in hs-CRP

    baseline, 6 month

  • Change in Myostatin

    baseline, 6 month

  • Change in Activing A

    baseline, 6 month

  • +5 more secondary outcomes

Study Arms (2)

Multidomain intervention group

EXPERIMENTAL

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

Behavioral: Multi-domain intervention

Usual care group

NO INTERVENTION

Provide conventional health educations in every three-month interval

Interventions

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

Multidomain intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 112, Taiwan

RECRUITING

Study Officials

  • Li-Ning Peng, M.D., PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Ning Peng, M.D., PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 28, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations