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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805620
• Other study ID #: AMS-CMU
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: June 28, 2021

Study information

• Verified date: July 2021
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 28, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Combined physical-cognitive training
combined physical-cognitive training
• Physical training
Multi-component physical exercise
• Cognitive training
cognitive training

Locations

Country	Name	City	State
Thailand	Faculty of Associated Medical Sciences, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change from baseline Rey auditory verbal learning score at 3 months	Memory will be assessed using Rey auditory verbal learning test.	3 months
Primary	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
Primary	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	change from baseline Digit Span score at 3 months	Attention will be assessed using Digit Span forward-backward test.	3 months
Secondary	change from baseline stepping response time at 3 months	Processing speed will be measured using stepping response time.	3 months
Secondary	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
Secondary	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
Secondary	change from baseline mitochondrial oxygen consumption rate at 3 months	Mitochondrial function will be determined from oxygen consumption rate (OCR)	3 months
Secondary	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