Low-intensity Physical-cognitive Exercise and Cognitive Function

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06201533
• Other study ID #: RSA660640
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2026

Study information

• Verified date: March 2024
• Source: Chiang Mai University
• Contact: S Kumfu
• Phone: 6653949249
• Email: sirintip.ku[@]up.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Thailand	Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

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