Brain Aging: Muscle-to-brain Axis Modulates Physio-cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Physical performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Usual care group
Provide conventional health educations in every three-month interval
Multidomain intervention group
The multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week.
干预措施: Multi-domain intervention (Behavioral)
结局指标
主要结局
Change in Physical performance
时间窗: 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
时间窗: baseline, 12 month
Change in brain structures from baseline to 12 months in all participants
次要结局
- Change in Nutrition intake(baseline, 6, 12 month)
- Change in depression(baseline, 6, 12 month)
- Change in cognitive ability(baseline, 6, 12 month)
- Change in TSH(baseline, 6, 12 month)
- Change in Myostatin(baseline, 6, 12 month)
- Change in Follistatin(baseline, 6, 12 month)
- Change in body fat %(baseline, 6, 12 month)
- Life quality SF12(baseline, 6, 12 month)
- Change in Complete blood count(baseline, 6, 12 month)
- Change in International Physical Activity Questionnaire (IPAQ)(baseline, 6, 12 month)
- Change in Zinc(baseline, 6, 12 month)
- Change in Vitamin D3 25-OH(baseline, 6, 12 month)
- Change in DHEA-S(baseline, 6, 12 month)
- Change in IGF-1(baseline, 6, 12 month)
- Change in Homocysteine(baseline, 6, 12 month)
- Change in hs-CRP(baseline, 6, 12 month)
- Change in Activing A(baseline, 6, 12 month)
- Change in Relative appendicular skeletal muscle index (RASM)(baseline, 6, 12 month)
研究者
Liang-Kung Chen,MD
Professor
National Yang Ming Chiao Tung University