Age-related Functional DeclineNCT06660706
The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers
A study testing Multi-domain intervention in people with Age-related Functional Decline, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age-related Functional Decline
- What is being tested?
- Multi-domain intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
Taipei, 112
Li-Ning Peng, M.D., PhD, +886-28239014, lining.peng@gmail.com
About this study
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.
- Conditions
- Age-related Functional Decline
- Being tested
- Multi-domain intervention
- Keywords
- aging, muscle health, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Multidomain intervention group | Experimental | The multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week. Receives: Behavioral: Multi-domain intervention |
| Usual care group | No intervention | Provide conventional health educations in every three-month interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 month
Secondary outcomes (10)
Change in DHEA-S
Change in DHEA-S concentration from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in IGF-1
Change in IGF-1 concentration from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in hs-CRP
Change in hs-CRP concentration from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in Myostatin
Change in Myostatin concentration from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in Activing A
Change in Activing A concentration from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in Follistatin
Change in Follistatin concentration from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in Relative appendicular skeletal muscle index (RASM)
Change in RASM from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in body fat %
Change in body fat % from baseline to 6 months in all participants
Measured: baseline, 6 month
Change in Cognitive performance
Change in Montreal Cognitive Assessment (MoCA), or Mini-mental state examination (MMSE) from baseline to 6months in all participants
Measured: baseline, 6 month
Change from lipoproflie
Change in Total Cholesterol, Triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol from baseline to 6months in all participants
Measured: baseline, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Apr 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Functional DeclineStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Li-Ning Peng, National Yang Ming Chiao Tung University
- Investigators
- Li-Ning Peng, M.D., PhD, Principal investigator, Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660706
- Sponsor's protocol ID
- NYCU112162AF
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers
- ClinicalTrials.gov ID
- NCT06660706
- Acronym / sponsor ID
- NYCU112162AF
- Conditions
- Age-related Functional Decline
- Keywords
- aging, muscle health, body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidomain intervention group | Experimental | Behavioral: Multi-domain interventionThe multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week. |
| Usual care group | No intervention | –Provide conventional health educations in every three-month interval |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-domain interventionEach 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 | Behavioural | Multidomain intervention group |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-Ning Peng, M.D., PhD principal investigator
Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-domain intervention in people with Age-related Functional Decline, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Ning Peng, M.D., PhD (+886-28239014, lining.peng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical performance (time frame: baseline, 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.