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

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Age-related Cognitive Decline; Age-related Physiology Decline

Treatments: Behavioral: Multi-domain intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05828043

YM109161F

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Usual care group

No Intervention group

Description:

Provide conventional health educations in every three-month interval

Multidomain intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Multi-domain intervention