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Low-intensity Physical-cognitive Exercise and Cognitive Function

Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06201533
Enrollment
64
Registered
2024-01-11
Start date
2024-04-07
Completion date
2026-03-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment, low intensity exercise, cognitive function, fibroblast growth factor 21

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.

Detailed description

Accumulating evidence suggests that dementia may be preventable, especially at an early stage. Mild cognitive impairment (MCI), a preclinical phase of dementia, is a potentially reversible condition as several individuals with MCI could revert to normal level of cognition. Exercise has shown promising evidence of neurocognitive protection, however, not all studies reported such benefits. Type and intensity of exercise are two main factors that have often been accounted for discrepancies in previous findings. Based on previous evidence, low-intensity and combined physical-cognitive exercise might give the best result for cognitive enhancement. Thus, this study aims to examine the effects of low-intensity, combined physical-cognitive training on cognitive function of older people with MCI and identify the mechanisms by which this exercise protocol exerts cognitive function in individuals with MCI. A single-blinded, randomized controlled trial will be conducted. 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. Outcome measures will be assessed at baseline and after a 3-month exercise. The primary outcome measures will be cognitive performance (specific and global cognitive function) and plasma brain-derived neurotrophic factor (BDNF). The secondary outcomes will include physical performance (functional mobility and strength), interleukin 6 (IL-6), fibroblast growth factor 21 (FGF21), and metabolomic profiles. Intention-to-treat method will be applied for data analyses.

Interventions

BEHAVIORALcombined physical-cognitive exercise

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

Sponsors

Chiang Mai University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Memory12 weeksLogical memory test will be evaluated at baseline and 12 weeks.
ADAS-Cog12 weeksAlzheimer'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.
Executive function12 weeksTrail making test (TMT) part B-A will be evaluated at baseline and 12 weeks.
Plasma BDNF12 weekssLevel of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks.

Secondary

MeasureTime frameDescription
FGF2112 weeksLevel of plasma fibroblast growth factor 21 (FGF21) will be assessed at baseline and 12 weeks.
Attention12 weeksDigit span forward-backward will be evaluated at baseline and 12 weeks
Plasma IL-612 weeksLevel of plasma IL-6 will be assessed at baseline and 12 weeks.

Countries

Thailand

Contacts

CONTACTS Kumfu
sirintip.ku@up.ac.th6653949249
PRINCIPAL_INVESTIGATORS Sungkarat, PhD

Chiang Mai University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026