Mild Cognitive ImpairmentNCT06201533
Low-intensity Physical-cognitive Exercise and Cognitive Function
A study testing combined physical-cognitive exercise in people with Mild Cognitive Impairment, run by Chiang Mai University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- combined physical-cognitive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 7 Apr 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of medical condition(s) unsafe to exercise or affect cognition and mobility
- presence of depressive symptoms
- exercise regularly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, 50200
Somporn Sungkarat, PhD, +6653-94-9249, somporn.sungkarat@cmu.ac.th
Somporn Sungkarat, PhD
About this study
Official title: Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia
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.
Read the 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
- Being tested
- combined physical-cognitive exercise
- Keywords
- mild cognitive impairment, low intensity exercise, cognitive function, fibroblast growth factor 21
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined physical-cognitive exerciseBehavioural
A combined physical-cognitive exercise will be delivered in the form of exergame, where the participants move their body to interact with the game.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity, combined physical-cognitive exercise | Experimental | The exercise program will be prescribed at low intensity for 50 minutes/session, 3 times /week for 12 consecutive weeks. Receives: Behavioral: combined physical-cognitive exercise |
| Control | No intervention | Participants will be asked to maintain their routine lifestyle throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Memory
Logical memory test will be evaluated at baseline and 12 weeks.
Measured: 12 weeks
Executive function
Trail making test (TMT) part B-A will be evaluated at baseline and 12 weeks.
Measured: 12 weeks
Plasma BDNF
Level of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks.
Measured: 12 weekss
Secondary outcomes (3)
Attention
Digit span forward-backward will be evaluated at baseline and 12 weeks
Measured: 12 weeks
Plasma IL-6
Level of plasma IL-6 will be assessed at baseline and 12 weeks.
Measured: 12 weeks
FGF21
Level of plasma fibroblast growth factor 21 (FGF21) will be assessed at baseline and 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start7 Apr 2024
- Primary completion25 Jan 2026
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somporn Sungkarat, Chiang Mai University
- Investigators
- S Sungkarat, PhD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201533
- Sponsor's protocol ID
- RSA660640
- Status last verified
- Feb 2026
- First submitted
- 30 Dec 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40468210
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia
- ClinicalTrials.gov ID
- NCT06201533
- Acronym / sponsor ID
- RSA660640
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, low intensity exercise, cognitive function, fibroblast growth factor 21
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity, combined physical-cognitive exercise | Experimental | Behavioral: combined physical-cognitive exerciseThe exercise program will be prescribed at low intensity for 50 minutes/session, 3 times /week for 12 consecutive weeks. |
| Control | No intervention | –Participants will be asked to maintain their routine lifestyle throughout the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- presence of medical condition(s) unsafe to exercise or affect cognition and mobility
- presence of depressive symptoms
- exercise regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined physical-cognitive exerciseA combined physical-cognitive exercise will be delivered in the form of exergame, where the participants move their body to interact with the game. | Behavioural | Low-intensity, combined physical-cognitive exercise |
Primary outcome
ADAS-Cog
Time frame: 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
Time frame: 12 weeks
Logical memory test will be evaluated at baseline and 12 weeks.
Executive function
Time frame: 12 weeks
Trail making test (TMT) part B-A will be evaluated at baseline and 12 weeks.
Plasma BDNF
Time frame: 12 weekss
Level of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks.
3 secondary outcomes
Attention
Time frame: 12 weeks
Plasma IL-6
Time frame: 12 weeks
FGF21
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 40468210Kumfu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
S Sungkarat, PhD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined physical-cognitive exercise in people with Mild Cognitive Impairment, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact S Kumfu (6653949249, sirintip.ku@up.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.