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Age-related Cognitive DeclineNCT05828043

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

A study testing Multi-domain intervention in people with Age-related Cognitive Decline and Age-related Physiology Decline, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Multi-domain intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTaiwan
Study dates
1 Nov 2021to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

    Taipei, 112

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Multi-domain intervention
Keywords
frailty, cognitive impairment, physio-cognitive decline syndrome, dementia, biomarkers, skeletal muscle, aging, neuroimaging, multidomain intervention
Medical subject headings
Frailty, Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-domain interventionBehavioural

    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

Study groups in NCT05828043
Study groupRoleWhat they receive
Usual care groupNo interventionProvide conventional health educations in every three-month interval
Multidomain intervention groupExperimentalThe multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week.
Receives: Behavioral: Multi-domain intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in brain structures on MRI

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

    Measured: baseline, 12 month

  2. 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

    Measured: baseline, 6, 12 month

Secondary outcomes (18)

  1. Life quality SF12

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

    Measured: baseline, 6, 12 month

  2. Change in Complete blood count

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

    Measured: baseline, 6, 12 month

  3. Change in Nutrition intake

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

    Measured: baseline, 6, 12 month

  4. Change in depression

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

    Measured: baseline, 6, 12 month

  5. Change in cognitive ability

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

    Measured: baseline, 6, 12 month

  6. 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.

    Measured: baseline, 6, 12 month

  7. Change in Vitamin D3 25-OH

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

    Measured: baseline, 6, 12 month

  8. Change in DHEA-S

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

    Measured: baseline, 6, 12 month

  9. Change in IGF-1

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

    Measured: baseline, 6, 12 month

  10. Change in Homocysteine

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

    Measured: baseline, 6, 12 month

  11. Change in hs-CRP

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

    Measured: baseline, 6, 12 month

  12. Change in Zinc

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

    Measured: baseline, 6, 12 month

  13. Change in TSH

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

    Measured: baseline, 6, 12 month

  14. Change in Myostatin

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

    Measured: baseline, 6, 12 month

  15. Change in Activing A

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

    Measured: baseline, 6, 12 month

  16. Change in Follistatin

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

    Measured: baseline, 6, 12 month

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

    Change in RASM from baseline to 12 months in all participants

    Measured: baseline, 6, 12 month

  18. Change in body fat %

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

    Measured: baseline, 6, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start1 Nov 2021
  3. Primary completion30 Jul 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828043
Sponsor's protocol ID
YM109161F
Status last verified
Dec 2023
First submitted
13 Apr 2023
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi-domain intervention in people with Age-related Cognitive Decline and Age-related Physiology Decline, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in brain structures on MRI (time frame: baseline, 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05828043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.

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