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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Physical training; Other: Cognitive training; Other: Combined physical-cognitive training

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Faculty of Associated Medical Sciences, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
change from baseline Rey auditory verbal learning score at 3 months	Memory will be assessed using Rey auditory verbal learning test.	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.	3 months
change from baseline brain-derived neurotrophic factor level at 3 months	Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cognitive function; mild cognitive impairment; BDNF; mitochondrial function; combined physical-cognitive training
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AMS-CMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No