Mild Cognitive Impairment Clinical Trial
Official title:
Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia
NCT number | NCT06201533 |
Other study ID # | RSA660640 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 7, 2024 |
Est. completion date | October 2026 |
Verified date | May 2024 |
Source | Chiang Mai University |
Contact | S Kumfu |
Phone | 6653949249 |
sirintip.ku[@]up.ac.th | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | October 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University | Chiang Mai |
Lead Sponsor | Collaborator |
---|---|
Chiang Mai University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Memory | Logical memory test will be evaluated at baseline and 12 weeks. | 12 weeks | |
Primary | Executive function | Trail making test (TMT) part B-A will be evaluated at baseline and 12 weeks. | 12 weeks | |
Primary | Plasma BDNF | Level of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks. | 12 weekss | |
Secondary | Attention | Digit span forward-backward will be evaluated at baseline and 12 weeks | 12 weeks | |
Secondary | Plasma IL-6 | Level of plasma IL-6 will be assessed at baseline and 12 weeks. | 12 weeks | |
Secondary | FGF21 | Level of plasma fibroblast growth factor 21 (FGF21) will be assessed at baseline and 12 weeks. | 12 weeks |
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