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

NCT03805620 | Completed

• 1 other identifier: AMS-CMU
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment; combined physical-cognitive training; BDNF; mitochondrial function; cognitive function

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• change from baseline Digit Span score at 3 months

  3 months

• 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 cellular oxidative stress level at 3 months

  3 months

Study Arms (4)

Phys Group

ACTIVE COMPARATOR

physical training group

Other: Physical training

Cog Group

ACTIVE COMPARATOR

cognitive training group

Other: Cognitive training

Phys-Cog Group

EXPERIMENTAL

combined physical-cognitive training group

Other: Combined physical-cognitive training

Con Group

NO INTERVENTION

educational control group

Interventions

Combined physical-cognitive training OTHER

combined physical-cognitive training

Phys-Cog Group

Physical training OTHER

Multi-component physical exercise

Phys Group

Cognitive training OTHER

cognitive training

Cog Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Faculty of Associated Medical Sciences, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Physical Conditioning, Human; Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Somporn Sungkarat, PhD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 15, 2019
• Study Start: March 18, 2019
• Primary Completion: January 15, 2021
• Study Completion: June 28, 2021
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)