Low-intensity Physical-cognitive Exercise and Cognitive Function

NCT ID: NCT06201533

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-07
• Study Completion Date: 2026-10-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Low-intensity, combined physical-cognitive exercise

The exercise program will be prescribed at low intensity for 50 minutes/session, 3 times /week for 12 consecutive weeks.

Group Type: EXPERIMENTAL

combined physical-cognitive exercise

Intervention Type: 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.

Control

Participants will be asked to maintain their routine lifestyle throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Somporn Sungkarat

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

S Sungkarat, PhD

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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

Chiang Mai, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

S Kumfu

Role: CONTACT

sirintip.ku@up.ac.th

6653949249

Facility Contacts

Somporn Sungkarat, PhD

Role: primary

somporn.sungkarat@cmu.ac.th

+6653-94-9249

References

Kumfu S, Sungkarat S, Boripantakul S, Sa-Nguanmoo P, Chattipakorn SC. Effects of home-based, low-intensity exergaming on cognitive function of individuals with mild cognitive impairment: a study protocol for a randomized controlled trial. BMC Geriatr. 2025 Jun 4;25(1):408. doi: 10.1186/s12877-025-06054-w.

Reference Type: DERIVED

PMID: 40468210 (View on PubMed)

Other Identifiers

RSA660640

Identifier Type: -

Identifier Source: org_study_id