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Completed

NCT Number: NCT05828043

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

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.

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Key information

Conditions

Age-related Cognitive Decline Age-related Physiology Decline Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Frailty Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-domain intervention

Behavioral

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

Primary outcomes

  1. Change in brain structures on MRI

    Time frame: baseline, 12 month

    Change in brain structures from baseline to 12 months in all participants

  2. Change in Physical performance

    Time frame: 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

Secondary outcomes

  1. Life quality SF12

    Time frame: baseline, 6, 12 month

    measured by the 12-Item Short Form Health Survey (SF-12).

  2. Change in Complete blood count

    Time frame: baseline, 6, 12 month

    Change in Complete blood count from baseline to 12 months in all participants

  3. Change in Nutrition intake

    Time frame: baseline, 6, 12 month

    measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition

  4. Change in depression

    Time frame: baseline, 6, 12 month

    measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition

  5. Change in cognitive ability

    Time frame: baseline, 6, 12 month

    Change in cognitive function measure by MoCA ranged 0-30, higher values represent a better condition

  6. Change in International Physical Activity Questionnaire (IPAQ)

    Time frame: 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.

  7. Change in Vitamin D3 25-OH

    Time frame: baseline, 6, 12 month

    Change in Vitamin D3 25-OH concentration from baseline to 12 months in all participants

  8. Change in DHEA-S

    Time frame: baseline, 6, 12 month

    Change in DHEA-S concentration from baseline to 12 months in all participants

  9. Change in IGF-1

    Time frame: baseline, 6, 12 month

    Change in IGF-1 concentration from baseline to 12 months in all participants

  10. Change in Homocysteine

    Time frame: baseline, 6, 12 month

    Change in Homocysteine concentration from baseline to 12 months in all participants

  11. Change in hs-CRP

    Time frame: baseline, 6, 12 month

    Change in hs-CRP concentration from baseline to 12 months in all participants

  12. Change in Zinc

    Time frame: baseline, 6, 12 month

    Change in Zinc concentration from baseline to 12 months in all participants

  13. Change in TSH

    Time frame: baseline, 6, 12 month

    Change in TSH concentration from baseline to 12 months in all participants

  14. Change in Myostatin

    Time frame: baseline, 6, 12 month

    Change in Myostatin concentration from baseline to 12 months in all participants

  15. Change in Activing A

    Time frame: baseline, 6, 12 month

    Change in Activing A concentration from baseline to 12 months in all participants

  16. Change in Follistatin

    Time frame: baseline, 6, 12 month

    Change in Follistatin concentration from baseline to 12 months in all participants

  17. Change in Relative appendicular skeletal muscle index (RASM)

    Time frame: baseline, 6, 12 month

    Change in RASM from baseline to 12 months in all participants

  18. Change in body fat %

    Time frame: baseline, 6, 12 month

    Change in body fat % from baseline to 12 months in all participants

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • National Science and Technology Council

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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