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

The purposes of this study are:

1. To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
2. 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;
3. 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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease; Mild CognitIve Impairment
• Intervention / Treatment: Other: Aerobic exercise; Other: Stretch exercise

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:

1. To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
2. 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;
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise intervention; Aerobic exercise and dual-task training	Other: Aerobic exercise; Aerobic exercise and dual-task training
Active Comparator: Stretch exercise; Stretch exercise & sitting balance	Other: Stretch exercise; Stretch exercise & sitting balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Color Trails Test at week12 and Week24	To investigate the cognitive executive function	Baseline, Week12, Week24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in walking speed at week12 and Week24	To investigate walking ability	baseline, week12 and Week24

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Ming-Jang Chiu, PhD, Neurology department, National Taiwan University Hospital; Principal Investigator: Yu-Hsiu Chu, PhD, Department of Physical Therapy, China Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Cognitive function; Exercise training; Mild CognitIve impairment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 200912126R