Mild Cognitive ImpairmentNCT03805620
Effects of Combined Physical-cognitive Training on Cognitive Function in MCI
A study testing Combined physical-cognitive training, Physical training and Cognitive training in people with Mild Cognitive Impairment, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Combined physical-cognitive training, Physical training and Cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteThailand
- Study dates
- 18 Mar 2019to 28 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based on the recent DSM-V (Diagnostic Statistical Manual-V) criteria
- comprehend instructions and willing to participate
- able to comply with the study schedule and procedures
- not taking any medications for their cognition and not planning to start medications during the study trial
Who cannot join
- presence of medical conditions that would be unsafe to exercise
- diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis, AD) that affect cognition and mobility
- presence of depressive symptoms
- presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
- exercise regularly (at least 30 min/day, 3 days/week)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, 50200
About this study
Official title: Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will be superior to the physical and cognitive training program alone; and 2) the degree of cognitive improvement will be positively correlated with the improvement of plasma BDNF and mitochondrial function.
Read the detailed description
Recent research suggests that the benefits of combined physical-cognitive training may be greater than either physical or cognitive training alone. Nevertheless, this synergistic effect has been demonstrated mainly in cognitively intact older adults. Studies examining the effects of combined physical-cognitive training in older adults with MCI are scarce and show mixed results. Moreover, few studies have determined the effects of the combined training on peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. The present study will provide insight into the interplay among the training program, peripheral BDNF concentration, mitochondrial function, and cognitive function. Importantly, the findings will have clinical implication regarding the training program that is feasible and effective in improving cognitive function of older adults with MCI which ultimately will have great impact on public health as this population is at high risk of progression to AD.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Combined physical-cognitive training, Physical training, Cognitive training
- Keywords
- mild cognitive impairment, combined physical-cognitive training, BDNF, mitochondrial function, cognitive function
- 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 trainingOther
combined physical-cognitive training
Physical trainingOther
Multi-component physical exercise
Cognitive trainingOther
cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Phys Group | Active comparator | physical training group Receives: Other: Physical training |
| Cog Group | Active comparator | cognitive training group Receives: Other: Cognitive training |
| Phys-Cog Group | Experimental | combined physical-cognitive training group Receives: Other: Combined physical-cognitive training |
| Con Group | No intervention | educational control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
Alzheimer's Disease Assessment-cognitive subscale will be assessed at baseline and 3 months. The total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
Measured: 3 months
change from baseline Rey auditory verbal learning score at 3 months
Memory will be assessed using Rey auditory verbal learning test.
Measured: 3 months
change from baseline Trail Making B-A score at 3 months
Executive function will be assessed using Trail Making Test part B-A.
Measured: 3 months
change from baseline brain-derived neurotrophic factor level at 3 months
Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.
Measured: 3 months
Secondary outcomes (5)
change from baseline Digit Span score at 3 months
Attention will be assessed using Digit Span forward-backward test.
Measured: 3 months
change from baseline stepping response time at 3 months
Processing speed will be measured using stepping response time.
Measured: 3 months
change from baseline time to complete Timed Up and Go at 3 months
Functional ability will be assessed using time to complete Timed Up and Go (TUG).
Measured: 3 months
change from baseline physiological profile assessment score at 3 months
Fall risk will be assessed using the physiological profile assessment. The test consists of five sensorimotor and balance measures including visual contrast sensitivity, proprioception, quadriceps muscle strength, hand reaction time, and postural sway. The five PPA components are weighted to compute a composite z-score distribution with high scores indicating increased fall risk.
Measured: 3 months
change from baseline cellular oxidative stress level at 3 months
Mitochondrial function will be determined from cellular oxidative stress level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start18 Mar 2019
- Primary completion15 Jan 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somporn Sungkarat, Chiang Mai University
- Investigators
- Somporn Sungkarat, PhD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805620
- Sponsor's protocol ID
- AMS-CMU
- Status last verified
- May 2024
- First submitted
- 7 Jan 2019
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03805620
- Acronym / sponsor ID
- AMS-CMU
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, combined physical-cognitive training, BDNF, mitochondrial function, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 15 Jan 2019 (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.
The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will be superior to the physical and cognitive training program alone; and 2) the degree of cognitive improvement will be positively correlated with the improvement of plasma BDNF and mitochondrial function.
Detailed description
Recent research suggests that the benefits of combined physical-cognitive training may be greater than either physical or cognitive training alone. Nevertheless, this synergistic effect has been demonstrated mainly in cognitively intact older adults. Studies examining the effects of combined physical-cognitive training in older adults with MCI are scarce and show mixed results. Moreover, few studies have determined the effects of the combined training on peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. The present study will provide insight into the interplay among the training program, peripheral BDNF concentration, mitochondrial function, and cognitive function. Importantly, the findings will have clinical implication regarding the training program that is feasible and effective in improving cognitive function of older adults with MCI which ultimately will have great impact on public health as this population is at high risk of progression to AD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phys Group | Active comparator | Other: Physical trainingphysical training group |
| Cog Group | Active comparator | Other: Cognitive trainingcognitive training group |
| Phys-Cog Group | Experimental | Other: Combined physical-cognitive trainingcombined physical-cognitive training group |
| Con Group | No intervention | –educational control group |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based on the recent DSM-V (Diagnostic Statistical Manual-V) criteria
- comprehend instructions and willing to participate
- able to comply with the study schedule and procedures
- not taking any medications for their cognition and not planning to start medications during the study trial
Key exclusion criteria (5 listed)
- presence of medical conditions that would be unsafe to exercise
- diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis, AD) that affect cognition and mobility
- presence of depressive symptoms
- presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
- exercise regularly (at least 30 min/day, 3 days/week)
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 trainingcombined physical-cognitive training | Other | Phys-Cog Group |
| Physical trainingMulti-component physical exercise | Other | Phys Group |
| Cognitive trainingcognitive training | Other | Cog Group |
Primary outcome
change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
Time frame: 3 months
Alzheimer's Disease Assessment-cognitive subscale will be assessed at baseline and 3 months. The total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
change from baseline Rey auditory verbal learning score at 3 months
Time frame: 3 months
Memory will be assessed using Rey auditory verbal learning test.
change from baseline Trail Making B-A score at 3 months
Time frame: 3 months
Executive function will be assessed using Trail Making Test part B-A.
change from baseline brain-derived neurotrophic factor level at 3 months
Time frame: 3 months
Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.
5 secondary outcomes
change from baseline Digit Span score at 3 months
Time frame: 3 months
change from baseline stepping response time at 3 months
Time frame: 3 months
change from baseline time to complete Timed Up and Go at 3 months
Time frame: 3 months
change from baseline physiological profile assessment score at 3 months
Time frame: 3 months
change from baseline cellular oxidative stress level at 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- 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. This study is not recruiting at the moment.
Somporn 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 training, Physical training and Cognitive training 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months (time frame: 3 months). 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?
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 29 May 2024.