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

Age-related Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05828043
• Other study ID #: YM109161F
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Taiwan	Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain structures on MRI	Change in brain structures from baseline to 12 months in all participants	baseline, 12 month
Primary	Change in Physical performance	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	baseline, 6, 12 month
Secondary	Life quality SF12	measured by the 12-Item Short Form Health Survey (SF-12).	baseline, 6, 12 month
Secondary	Change in Complete blood count	Change in Complete blood count from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Nutrition intake	measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition	baseline, 6, 12 month
Secondary	Change in depression	measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition	baseline, 6, 12 month
Secondary	Change in cognitive ability	Change in cognitive function measure by MoCA ranged 0-30, higher values represent a better condition	baseline, 6, 12 month
Secondary	Change in International Physical Activity Questionnaire (IPAQ)	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.	baseline, 6, 12 month
Secondary	Change in Vitamin D3 25-OH	Change in Vitamin D3 25-OH concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in DHEA-S	Change in DHEA-S concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in IGF-1	Change in IGF-1 concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Homocysteine	Change in Homocysteine concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in hs-CRP	Change in hs-CRP concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Zinc	Change in Zinc concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in TSH	Change in TSH concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Myostatin	Change in Myostatin concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Activing A	Change in Activing A concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Follistatin	Change in Follistatin concentration from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in Relative appendicular skeletal muscle index (RASM)	Change in RASM from baseline to 12 months in all participants	baseline, 6, 12 month
Secondary	Change in body fat %	Change in body fat % from baseline to 12 months in all participants	baseline, 6, 12 month