Clinical trial NCT05828043: Brain Aging: Muscle-to-brain Axis Modulates Physio-cognitive Decline
Official title: Brain Aging: Muscle-to-brain Axis Modulates Physio-cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Age-related Physiology Decline
Keywords: frailty
cognitive impairment
physio-cognitive decline syndrome
dementia
biomarkers
skeletal muscle
aging
neuroimaging
multidomain intervention
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-04-25
Enrollment: 102
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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 brain structures on MRI
timeFrame: baseline, 12 month
measure: Change in Physical performance
timeFrame: baseline, 6, 12 month
Secondary outcomes:
measure: Life quality SF12
timeFrame: baseline, 6, 12 month
measure: Change in Complete blood count
timeFrame: baseline, 6, 12 month
measure: Change in Nutrition intake
timeFrame: baseline, 6, 12 month
measure: Change in depression
timeFrame: baseline, 6, 12 month
measure: Change in cognitive ability
timeFrame: baseline, 6, 12 month
measure: Change in International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline, 6, 12 month
measure: Change in Vitamin D3 25-OH
timeFrame: baseline, 6, 12 month
measure: Change in DHEA-S
timeFrame: baseline, 6, 12 month
measure: Change in IGF-1
timeFrame: baseline, 6, 12 month
measure: Change in Homocysteine
timeFrame: baseline, 6, 12 month
measure: Change in hs-CRP
timeFrame: baseline, 6, 12 month
measure: Change in Zinc
timeFrame: baseline, 6, 12 month
measure: Change in TSH
timeFrame: baseline, 6, 12 month
measure: Change in Myostatin
timeFrame: baseline, 6, 12 month
measure: Change in Activing A
timeFrame: baseline, 6, 12 month
measure: Change in Follistatin
timeFrame: baseline, 6, 12 month
measure: Change in Relative appendicular skeletal muscle index (RASM)
timeFrame: baseline, 6, 12 month
measure: Change in body fat %
timeFrame: baseline, 6, 12 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: Liang-Kung Chen, M.D., PhD
role: STUDY_DIRECTOR
References: