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

Sponsor

National Yang Ming University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05828043

Collaborator

National Science and Technology Council (U.S. Fed)

102

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goal is to develop an enhanced intervention program that can persistently maintain intervention effects with measurement of clinical characteristics, phenotypic features, together with biochemical profiles, myokines, proteomics, metabolomics brain imaging, and our previous findings of exosomal miRNA and to correlate changes of the biomarkers to neuroimaging. The linkage between both positive (irisin) and negative regulators (myostatin, miR-29b-3p) with structural brain imaging by a randomized controlled trial is the key novelty with strongest evidence strength in human study.

Condition or Disease	Intervention/Treatment	Phase
Age-related Cognitive Decline Age-related Physiology Decline	Behavioral: Multi-domain intervention	N/A

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), (3) subjective cognitive declines; subjects with the following conditions will be excluded: (1) established diagnosis of dementia, Parkinsonism or other mobility-limiting conditions, (2) active diseases receiving treatment, such as cancer, heart failure, COPD and so on, (3) estimated life expectancy <12 months, (4) current nursing home residents.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care group Provide conventional health educations in every three-month interval
Experimental: Multidomain intervention group The multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week.	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

Arm

Intervention/Treatment

No Intervention: Usual care group

Provide conventional health educations in every three-month interval

Experimental: Multidomain intervention group

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

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

Outcome Measures

Primary Outcome Measures

Change in MRI study [baseline, 12 month]
Change in MRI study from baseline to 12 months in all participants
Change in cognitive ability [baseline, 6, 12 month]
Change in cognitive function measure by MoCA , MMSE rom baseline to 12 months in all participants
Change in Physical performance [baseline, 6, 12 month]
Change in hand-grip strength (kg), six-meter walking speed (m/s) 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 thin 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.
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 Zinc [baseline, 6, 12 month]
Change in Zinc concentration from baseline to 12 months in all participants
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 Activing A [baseline, 6, 12 month]
Change in Activing A concentration from baseline to 12 months in all participants
Change in body composition analysis [baseline, 6, 12 month]
Change in RASM and body fat % from baseline to 12 months in all participants

Secondary Outcome Measures

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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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)
subjective cognitive declines

Exclusion Criteria:

established diagnosis of dementia, Parkinsonism or other mobility-limiting conditions
active diseases receiving treatment, such as cancer, heart failure, COPD and so on
estimated life expectancy <12 months
current nursing home residents