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Clinical Trials/NCT03805620
NCT03805620
Completed
Not Applicable

Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial

Chiang Mai University1 site in 1 country128 target enrollmentMarch 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Chiang Mai University
Enrollment
128
Locations
1
Primary Endpoint
change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
June 28, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Somporn Sungkarat

Associate Professor

Chiang Mai University

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)

Outcomes

Primary Outcomes

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 brain-derived neurotrophic factor level at 3 months

Time Frame: 3 months

Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.

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.

Secondary Outcomes

  • change from baseline stepping response time at 3 months(3 months)
  • change from baseline time to complete Timed Up and Go at 3 months(3 months)
  • change from baseline physiological profile assessment score at 3 months(3 months)
  • change from baseline Digit Span score at 3 months(3 months)
  • change from baseline cellular oxidative stress level at 3 months(3 months)

Study Sites (1)

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