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Recruiting NCT06201533

Low-intensity Physical-cognitive Exercise and Cognitive Function

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: combined physical-cognitive exercise.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral combined 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.

Primary outcome measures

  • ADAS-Cog [Time frame: 12 weeks]
  • Memory [Time frame: 12 weeks]
  • Executive function [Time frame: 12 weeks]
  • Plasma BDNF [Time frame: 12 weekss]
Secondary outcome measures (3)
  • Attention [Time frame: 12 weeks]
  • Plasma IL-6 [Time frame: 12 weeks]
  • FGF21 [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Thailand · 1 center
  • Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai Univers — Chiang Mai

Publications

  • 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 40468210

Identifiers

NCT: NCT06201533 · RSA660640

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗