Low-intensity Physical-cognitive Exercise and Cognitive Function

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: combined physical-cognitive exercise

• Registration Number: NCT06201533
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2023-12-30
• Study First Posted: 2024-01-11
• Study Start: 2024-04-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-25
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-03
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

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Exclusion Criteria

• presence of medical condition(s) unsafe to exercise or affect cognition and mobility
• presence of depressive symptoms
• exercise regularly

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-intensity, combined physical-cognitive exercise	combined physical-cognitive exercise	The exercise program will be prescribed at low intensity for 50 minutes/session, 3 times /week for 12 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
ADAS-Cog	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.
Memory	12 weeks	Logical memory test will be evaluated at baseline and 12 weeks.
Plasma BDNF	12 weekss	Level of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks.
Executive function	12 weeks	Trail making test (TMT) part B-A will be evaluated at baseline and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Attention	12 weeks	Digit span forward-backward will be evaluated at baseline and 12 weeks
Plasma IL-6	12 weeks	Level of plasma IL-6 will be assessed at baseline and 12 weeks.
FGF21	12 weeks	Level of plasma fibroblast growth factor 21 (FGF21) will be assessed at baseline and 12 weeks.

Trial Locations

Locations (1)

Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand