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NCT Number: NCT06201533

Low-intensity Physical-cognitive Exercise and Cognitive Function

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chiang Mai, 50200, Thailand

Location status: Recruiting

Location contact

Somporn Sungkarat, PhD

CONTACT

[email protected]

+6653-94-9249

Somporn Sungkarat, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined physical-cognitive exercise

Behavioral

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 outcomes

  1. ADAS-Cog

    Time frame: 12 weeks

    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.

  2. Memory

    Time frame: 12 weeks

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

  3. Executive function

    Time frame: 12 weeks

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

  4. Plasma BDNF

    Time frame: 12 weekss

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

Secondary outcomes

  1. Attention

    Time frame: 12 weeks

    Digit span forward-backward will be evaluated at baseline and 12 weeks

  2. Plasma IL-6

    Time frame: 12 weeks

    Level of plasma IL-6 will be assessed at baseline and 12 weeks.

  3. FGF21

    Time frame: 12 weeks

    Level of plasma fibroblast growth factor 21 (FGF21) will be assessed at baseline and 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

S Kumfu

CONTACT

[email protected]

6653949249

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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