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

NCT ID: NCT03805620

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2021-06-28

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Phys Group

physical training group

Group Type ACTIVE_COMPARATOR

Physical training

Intervention Type OTHER

Multi-component physical exercise

Cog Group

cognitive training group

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type OTHER

cognitive training

Phys-Cog Group

combined physical-cognitive training group

Group Type EXPERIMENTAL

Combined physical-cognitive training

Intervention Type OTHER

combined physical-cognitive training

Con Group

educational control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Combined physical-cognitive training

combined physical-cognitive training

Intervention Type OTHER

Physical training

Multi-component physical exercise

Intervention Type OTHER

Cognitive training

cognitive training

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Somporn Sungkarat

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Somporn Sungkarat, PhD

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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Faculty of Associated Medical Sciences, Chiang Mai University

Chiang Mai, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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AMS-CMU

Identifier Type: -

Identifier Source: org_study_id

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