Effect of Exercises Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

February 26, 2014 updated by: National Taiwan University Hospital

Effects and Mechanisms of Aerobic Exercises Combined With Dual-task Training in Cognitive Function in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

Recent studies have shown that aerobic exercises and dual-task training are effective in improving overall cognitive function in patients with cognitive impairment or dementia. However, the biological mechanisms are unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three main purposes of this study are: (1) to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD); (2) to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and (3) to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and cerebral blood flow.

We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group. Both groups will receive three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined.

Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent studies have shown that moderate-to-high intensity aerobic exercises are effective in improving overall cognitive function in patients with cognitive impairment or dementia. Dual-task training programs also show positive effects on enhancing executive function in patients with cognitive impairment. However, the biological mechanisms through which these training effects are mediated remain largely unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects of aerobic exercises and dual-task training on cognitive function of these patients. Therefore, the three main purposes of this study are:

  1. to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD);
  2. to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and
  3. to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine (TNF-α, Interleukin(IL) -Iβ, IL-6, CRP),integrity of brain fiber tracts, and cerebral blood flow.

We will conduct a single-blind (assessor blinded) randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group using stratified randomization by matching patient's diagnosis. Both groups will receive one health education session and three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises and activities in sitting of mild intensity. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine (TNF-α, IL-Iβ, IL-6, CRP),integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups using two-way (group x time) repeated measures of ANOVA. Intercorrelations among the changes in these outcomes will be analyzed to explore the possible biological mechanisms mediating the training effects. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined.

Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild cognitive impairment or mild AD.

Exclusion Criteria:

  • neurological disorders or psychiatric disorders, or any other systematic diseases that would affect their walking ability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercises
90-minute exercise sessions per week for 12 weeks
Other: Aerobic exercises
Aerobic exercises + dual task
Active Comparator: Stretch exercise
90-minute exercise sessions per week for 12 weeks
Other: Stretch exercise
Stretch exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of Memory and executive function related neuropsychological test
Time Frame: Changes from baseline in neuropsychological test at 3 months and 6 months
Changes from baseline in neuropsychological test at 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of muscle strength of upper and lower extremity and walking speed
Time Frame: Changes from baseline in muscle strength of upper and lower extremity and walking speed at 3 months and 6 months
Changes from baseline in muscle strength of upper and lower extremity and walking speed at 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Ming-Jang Chiu, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201012136RB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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