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Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

Primary Purpose

Mild CognitIve Impairment, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic exercise
Stretch exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild CognitIve Impairment focused on measuring Mild CognitIve impairment, Alzheimer's disease, Cognitive function, Exercise training

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 45~85 years old and had independent walking ability
  • The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal activity of daily living /instrumental activities of daily living, and not demented
  • Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable Alzheimer disease (McKhann, et al., 1984)

Exclusion Criteria:

  • The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise intervention

Stretch exercise

Arm Description

Aerobic exercise and dual-task training

Stretch exercise & sitting balance

Outcomes

Primary Outcome Measures

Change from baseline in Color Trails Test at week12 and Week24
To investigate the cognitive executive function

Secondary Outcome Measures

Change from baseline in walking speed at week12 and Week24
To investigate walking ability

Full Information

First Posted
November 19, 2012
Last Updated
April 18, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02119546
Brief Title
Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
Official Title
Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purposes of this study are: To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow; To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease; To investigate the influence of different apolipoprotein E (APOE) genotypes on the above-mentioned exercise effects. The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.
Detailed Description
Recent studies have shown that exercise training could decrease the risk of dementia in the elderly population. Exercise training could also slow down the speed of deterioration of memory and other cognitive functions in patients who already have mild cognitive impairment or early Alzheimer's disease. However, the mechanisms of such effects are still unknown. Whether exercise training could improve neural fiber integrity, blood flow, or motor performance of these patients also remain unexplored. Therefore, the purposes of this study are: To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow; To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease; To investigate the influence of different APOE genotypes on the above-mentioned exercise effects. We will conduct a single-blinded, randomized controlled clinical trial. We will recruit 60 patients with mild cognitive impairment or early Alzheimer's disease. The participants will be randomly classified into the exercise training group or control group. The exercise training group will receive health education and exercise training of moderate intensity, 3 times a week, for 12 weeks. The control group will receive health education only. Both groups will receive pre- (week 0), post- (week 12), and follow-up (week 24 after the end of the program) examinations for cognitive function, motor performance, diffusion tensor or diffusion spectrum magnetic resonance imaging, and transcranial duplex. We will compare the group differences on the aforementioned outcome measures brought by 12-week exercise training. We will also perform analysis of the correlations between the changes in these outcome measures to explore the possible neural or physiological mechanisms mediating the training effects. The effects of different APOE genotypes on these outcome measures will also be compared. The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild CognitIve Impairment, Alzheimer's Disease
Keywords
Mild CognitIve impairment, Alzheimer's disease, Cognitive function, Exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
Aerobic exercise and dual-task training
Arm Title
Stretch exercise
Arm Type
Active Comparator
Arm Description
Stretch exercise & sitting balance
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Aerobic exercise and dual-task training
Intervention Type
Other
Intervention Name(s)
Stretch exercise
Intervention Description
Stretch exercise & sitting balance
Primary Outcome Measure Information:
Title
Change from baseline in Color Trails Test at week12 and Week24
Description
To investigate the cognitive executive function
Time Frame
Baseline, Week12, Week24
Secondary Outcome Measure Information:
Title
Change from baseline in walking speed at week12 and Week24
Description
To investigate walking ability
Time Frame
baseline, week12 and Week24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 45~85 years old and had independent walking ability The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal activity of daily living /instrumental activities of daily living, and not demented Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable Alzheimer disease (McKhann, et al., 1984) Exclusion Criteria: The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Jang Chiu, PhD
Organizational Affiliation
Neurology department, National Taiwan University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yu-Hsiu Chu, PhD
Organizational Affiliation
Department of Physical Therapy, China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

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