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Brain Aging: Muscle-to-brain Axis Modulates Physio-cognitive Decline

NCT ID: NCT05828043

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-07-30

Brief Summary

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The primary goal is to develop a multidomain intervention program focused on preserving global or regional brain volume and functions while simultaneously improving physical mobility and cognitive functions in older individuals with mobility frailty. This initiative seeks to unravel the brain-muscle axis mechanisms contributing to the accelerated functional declines observed in older populations. Moreover, our objective includes examining the relationships between the intervention and a broad spectrum of clinical characteristics, phenotypic traits, biochemical profiles, myokines, proteomics, metabolomics, brain imaging, and our previously identified discoveries involving exosomal miRNA.

Detailed Description

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This study is a randomized controlled trial of 12-month multidomain intervention program among community-living older adults with early physical or cognitive 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: mobility-limiting 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

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Age-related Cognitive Decline Age-related Physiology Decline

Keywords

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frailty cognitive impairment physio-cognitive decline syndrome dementia biomarkers skeletal muscle aging neuroimaging multidomain intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care group

Provide conventional health educations in every three-month interval

Group Type NO_INTERVENTION

No interventions assigned to this group

Multidomain intervention group

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

Group Type EXPERIMENTAL

Multi-domain intervention

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council

FED

Sponsor Role collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Liang-Kung Chen,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liang-Kung Chen, M.D., PhD

Role: STUDY_DIRECTOR

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

Locations

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

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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YM109161F

Identifier Type: -

Identifier Source: org_study_id