Clinical trial NCT06201533: Low-intensity Physical-cognitive Exercise and Cognitive Function
Official title: Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
low intensity exercise
cognitive function
fibroblast growth factor 21
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: ADAS-Cog
timeFrame: 12 weeks
measure: Memory
timeFrame: 12 weeks
measure: Executive function
timeFrame: 12 weeks
measure: Plasma BDNF
timeFrame: 12 weekss
Secondary outcomes:
measure: Attention
timeFrame: 12 weeks
measure: Plasma IL-6
timeFrame: 12 weeks
measure: FGF21
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: S Sungkarat, PhD
role: PRINCIPAL_INVESTIGATOR
References: