Brain Aging: Muscle-to-brain Axis Modulates Physio-cognitive Decline
- Conditions
- Age-related Cognitive DeclineAge-related Physiology Decline
- Interventions
- Behavioral: Multi-domain intervention
- Registration Number
- NCT05828043
- Lead Sponsor
- National Yang Ming Chiao Tung University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multidomain intervention group Multi-domain intervention The multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week.
- Primary Outcome Measures
Name Time Method Change in Physical performance baseline, 6, 12 month Change in hand-grip strength (kg), six-meter walking speed (m/s), and 5 times sit to stand test from baseline to 12 months in all participants
Change in brain structures on MRI baseline, 12 month Change in brain structures from baseline to 12 months in all participants
- Secondary Outcome Measures
Name Time Method Change in Nutrition intake baseline, 6, 12 month measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Change in depression baseline, 6, 12 month measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
Change in cognitive ability baseline, 6, 12 month Change in cognitive function measure by MoCA ranged 0-30, higher values represent a better condition
Change in TSH baseline, 6, 12 month Change in TSH concentration from baseline to 12 months in all participants
Change in Myostatin baseline, 6, 12 month Change in Myostatin concentration from baseline to 12 months in all participants
Change in Follistatin baseline, 6, 12 month Change in Follistatin concentration from baseline to 12 months in all participants
Change in body fat % baseline, 6, 12 month Change in body fat % from baseline to 12 months in all participants
Life quality SF12 baseline, 6, 12 month measured by the 12-Item Short Form Health Survey (SF-12).
Change in Complete blood count baseline, 6, 12 month Change in Complete blood count from baseline to 12 months in all participants
Change in International Physical Activity Questionnaire (IPAQ) baseline, 6, 12 month Change in physical activity measured by IPAQ, indicates that spent being physically active than the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations from baseline to 12 months in all participants. The higher values represent a better activity.
Change in Zinc baseline, 6, 12 month Change in Zinc concentration from baseline to 12 months in all participants
Change in Vitamin D3 25-OH baseline, 6, 12 month Change in Vitamin D3 25-OH concentration from baseline to 12 months in all participants
Change in DHEA-S baseline, 6, 12 month Change in DHEA-S concentration from baseline to 12 months in all participants
Change in IGF-1 baseline, 6, 12 month Change in IGF-1 concentration from baseline to 12 months in all participants
Change in Homocysteine baseline, 6, 12 month Change in Homocysteine concentration from baseline to 12 months in all participants
Change in hs-CRP baseline, 6, 12 month Change in hs-CRP concentration from baseline to 12 months in all participants
Change in Activing A baseline, 6, 12 month Change in Activing A concentration from baseline to 12 months in all participants
Change in Relative appendicular skeletal muscle index (RASM) baseline, 6, 12 month Change in RASM from baseline to 12 months in all participants
Trial Locations
- Locations (1)
Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
🇨🇳Taipei, Taiwan