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Effects of Combined Physical-cognitive Training on Cognitive Function in MCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03805620
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Somporn Sungkarat, Chiang Mai University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: Combined physical-cognitive training Other: Physical training Other: Cognitive training Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
Actual Study Start Date : March 18, 2019
Actual Primary Completion Date : January 15, 2021
Actual Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Phys Group
physical training group
 Other: Physical training
Multi-component physical exercise
Active Comparator: Cog Group
cognitive training group
 Other: Cognitive training
cognitive training
Experimental: Phys-Cog Group
combined physical-cognitive training group
 Other: Combined physical-cognitive training
combined physical-cognitive training
No Intervention: Con Group
educational control group


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. change from baseline Digit Span score at 3 months [ Time Frame: 3 months ]
    Attention will be assessed using Digit Span forward-backward test.

  2. change from baseline stepping response time at 3 months [ Time Frame: 3 months ]
    Processing speed will be measured using stepping response time.

  3. change from baseline time to complete Timed Up and Go at 3 months [ Time Frame: 3 months ]
    Functional ability will be assessed using time to complete Timed Up and Go (TUG).

  4. change from baseline physiological profile assessment score at 3 months [ Time Frame: 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.

  5. change from baseline mitochondrial oxygen consumption rate at 3 months [ Time Frame: 3 months ]
    Mitochondrial function will be determined from oxygen consumption rate (OCR)

  6. change from baseline mitochondrial reactive oxygen species (ROS) level at 3 months [ Time Frame: 3 months ]
    Mitochondrial function will be determined from reactive oxygen species (ROS) level


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805620


Locations
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Thailand
Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Somporn Sungkarat, PhD Chiang Mai University
More Information
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Responsible Party: Somporn Sungkarat, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03805620    
Other Study ID Numbers: AMS-CMU
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Somporn Sungkarat, Chiang Mai University:
mild cognitive impairment
combined physical-cognitive training
BDNF
mitochondrial function
cognitive function
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders