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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Combined physical-cognitive training
Physical training
Cognitive training
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, combined physical-cognitive training, BDNF, mitochondrial function, cognitive function

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of Associated Medical Sciences, Chiang Mai University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

No Intervention

Arm Label

Phys Group

Cog Group

Phys-Cog Group

Con Group

Arm Description

physical training group

cognitive training group

combined physical-cognitive training group

educational control group

Outcomes

Primary Outcome Measures

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.
change from baseline Rey auditory verbal learning score at 3 months
Memory will be assessed using Rey auditory verbal learning test.
change from baseline Trail Making B-A score at 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
Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.

Secondary Outcome Measures

change from baseline Digit Span score at 3 months
Attention will be assessed using Digit Span forward-backward test.
change from baseline stepping response time at 3 months
Processing speed will be measured using stepping response time.
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).
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.
change from baseline mitochondrial oxygen consumption rate at 3 months
Mitochondrial function will be determined from oxygen consumption rate (OCR)
change from baseline mitochondrial reactive oxygen species (ROS) level at 3 months
Mitochondrial function will be determined from reactive oxygen species (ROS) level

Full Information

First Posted
January 7, 2019
Last Updated
July 22, 2021
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT03805620
Brief Title
Effects of Combined Physical-cognitive Training on Cognitive Function in MCI
Official Title
Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, combined physical-cognitive training, BDNF, mitochondrial function, cognitive function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phys Group
Arm Type
Active Comparator
Arm Description
physical training group
Arm Title
Cog Group
Arm Type
Active Comparator
Arm Description
cognitive training group
Arm Title
Phys-Cog Group
Arm Type
Experimental
Arm Description
combined physical-cognitive training group
Arm Title
Con Group
Arm Type
No Intervention
Arm Description
educational control group
Intervention Type
Other
Intervention Name(s)
Combined physical-cognitive training
Intervention Description
combined physical-cognitive training
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Description
Multi-component physical exercise
Intervention Type
Other
Intervention Name(s)
Cognitive training
Intervention Description
cognitive training
Primary Outcome Measure Information:
Title
change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
Description
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.
Time Frame
3 months
Title
change from baseline Rey auditory verbal learning score at 3 months
Description
Memory will be assessed using Rey auditory verbal learning test.
Time Frame
3 months
Title
change from baseline Trail Making B-A score at 3 months
Description
Executive function will be assessed using Trail Making Test part B-A.
Time Frame
3 months
Title
change from baseline brain-derived neurotrophic factor level at 3 months
Description
Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change from baseline Digit Span score at 3 months
Description
Attention will be assessed using Digit Span forward-backward test.
Time Frame
3 months
Title
change from baseline stepping response time at 3 months
Description
Processing speed will be measured using stepping response time.
Time Frame
3 months
Title
change from baseline time to complete Timed Up and Go at 3 months
Description
Functional ability will be assessed using time to complete Timed Up and Go (TUG).
Time Frame
3 months
Title
change from baseline physiological profile assessment score at 3 months
Description
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.
Time Frame
3 months
Title
change from baseline mitochondrial oxygen consumption rate at 3 months
Description
Mitochondrial function will be determined from oxygen consumption rate (OCR)
Time Frame
3 months
Title
change from baseline mitochondrial reactive oxygen species (ROS) level at 3 months
Description
Mitochondrial function will be determined from reactive oxygen species (ROS) level
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somporn Sungkarat, PhD
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Associated Medical Sciences, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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