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

NCT02074215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-02-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Aerobic exercises

Aerobic exercises + dual task

OTHER

Stretch exercise

Stretch exercise

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ming-Jang Chiu, PhD · National Taiwan University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02074215 on ClinicalTrials.gov