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Completed

NCT Number: NCT03805620

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Associated Medical Sciences, Chiang Mai University

Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Combined physical-cognitive training

Other

combined physical-cognitive training

Physical training

Other

Multi-component physical exercise

Cognitive Training

Other

cognitive training

Primary outcomes

  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 outcomes

  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 cellular oxidative stress level at 3 months

    Time frame: 3 months

    Mitochondrial function will be determined from cellular oxidative stress level

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2019
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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