NCT05828043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

April 13, 2023

Last Update Submit

December 19, 2023

Conditions

Age-related Cognitive DeclineAge-related Physiology Decline

Keywords

frailtycognitive impairmentphysio-cognitive decline syndromedementiabiomarkersskeletal muscleagingneuroimagingmultidomain intervention

Outcome Measures

Primary Outcomes (2)

  • Change in brain structures on MRI

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

    baseline, 12 month

  • 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 Outcomes (18)

  • Life quality SF12

    baseline, 6, 12 month

  • Change in Complete blood count

    baseline, 6, 12 month

  • Change in Nutrition intake

    baseline, 6, 12 month

  • Change in depression

    baseline, 6, 12 month

  • Change in cognitive ability

    baseline, 6, 12 month

  • +13 more secondary outcomes

Study Arms (2)

Usual care group

NO INTERVENTION

Provide conventional health educations in every three-month interval

Multidomain intervention group

EXPERIMENTAL

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

Behavioral: Multi-domain intervention

Interventions

Multi-domain interventionBEHAVIORAL

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

Multidomain intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

FrailtyCognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Liang-Kung Chen, M.D., PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 25, 2023

Study Start

November 1, 2021

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

December 26, 2023

Record last verified: 2023-12

Locations

TW(1)