NCT06201533

Brief Summary

This study aims to examine the effects of low-intensity, combined physical-cognitive exercise on cognitive function of older people with mild cognitive impairment (MCI) and identify the mechanisms by which this exercise protocol exerts cognitive function. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. It is hypothesized that at the end of the trial, participants in the exercise group will demonstrate significant improvement in cognitive performance and circulating biomarkers compared to baseline and the control group.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 7, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

December 30, 2023

Last Update Submit

February 18, 2026

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairmentlow intensity exercisecognitive functionfibroblast growth factor 21

Outcome Measures

Primary Outcomes (4)

  • ADAS-Cog

    Alzheimer's Disease Assessment-cognitive subscale (ADAS-Cog) will be assessed at baseline and 12 weeks. The total scores range from 0-70 with higher scores indicating greater cognitive impairment.

    12 weeks

  • Memory

    Logical memory test will be evaluated at baseline and 12 weeks.

    12 weeks

  • Executive function

    Trail making test (TMT) part B-A will be evaluated at baseline and 12 weeks.

    12 weeks

  • Plasma BDNF

    Level of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks.

    12 weekss

Secondary Outcomes (3)

  • Attention

    12 weeks

  • Plasma IL-6

    12 weeks

  • FGF21

    12 weeks

Study Arms (2)

Low-intensity, combined physical-cognitive exercise

EXPERIMENTAL

The exercise program will be prescribed at low intensity for 50 minutes/session, 3 times /week for 12 consecutive weeks.

Behavioral: combined physical-cognitive exercise

Control

NO INTERVENTION

Participants will be asked to maintain their routine lifestyle throughout the study period.

Interventions

combined physical-cognitive exerciseBEHAVIORAL

A combined physical-cognitive exercise will be delivered in the form of exergame, where the participants move their body to interact with the game.

Low-intensity, combined physical-cognitive exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meeting the criteria for MCI (or mNCD) based on the recent DSM-V criteria
  • comprehend instructions and able to comply with the study procedures
  • not taking any medications for their cognition and not planning to start medications during the study trial

You may not qualify if:

  • presence of medical condition(s) unsafe to exercise or affect cognition and mobility
  • presence of depressive symptoms
  • exercise regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (1)

  • Kumfu S, Sungkarat S, Boripantakul S, Sa-Nguanmoo P, Chattipakorn SC. Effects of home-based, low-intensity exergaming on cognitive function of individuals with mild cognitive impairment: a study protocol for a randomized controlled trial. BMC Geriatr. 2025 Jun 4;25(1):408. doi: 10.1186/s12877-025-06054-w.

    PMID: 40468210DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • S Sungkarat, PhD

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

S Kumfu

CONTACT

6653949249sirintip.ku@up.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 11, 2024

Study Start

April 7, 2024

Primary Completion

January 25, 2026

Study Completion

March 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)