Aerobic Exercise Training in Mild Cognitive Impairment Study (AETMCI)
This study is being done to find out whether regulation of brain blood flow is altered in patents with mild cognitive impairment (those who have memory problems but otherwise healthy) when compared with healthy elderly individuals. In addition, this study will determine whether exercise training improves brain blood flow and brain function in patients with mild cognitive impairment(MCI).
This is a research study because at present the investigators know little about brain blood flow regulation in patients with mild cognitive impairment. The investigators also know little about whether exercise training improves brain blood flow and brain function in patients with mild cognitive impairment.
Mild Cognitive Impairment
Behavioral: Balance training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Mild Cognitive Impairment:Cerebrovascular Dysfunction and Exercise|
- Cognitive function [ Time Frame: One year ] [ Designated as safety issue: No ]A comprehensive battery of neuropsychological tests focused on memory and executive function will be used to assess effects of exercise on cognitive function.
- Cerebrovascular function [ Time Frame: One year ] [ Designated as safety issue: No ]Transcranial Doppler and perfusion magnetic resonance imaging (MRI) will be used to measure cerebrovascular function/brain perfusion before and after exercise training.
- Brain tissue volume and white matter integrity [ Time Frame: One year ] [ Designated as safety issue: No ]Magnetic resonance imaging (MRI) will be used to measure changes in brain volume and white matter integrity before and after exercise training.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Patients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year.
|Placebo Comparator: Control group||
Behavioral: Balance training
A group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group.
We plan to screen 144 patients with mild cognitive impairment and 60 control subjects in order to enroll 204 participants in this research at the University of Texas Southwestern(UTSW) Medical Center Dallas and Texas Health Presbyterian Hospital Dallas - Institute for Exercise an Environmental Medicine (IEEM).
To help decide if you qualify to be in this study, the researchers may ask you questions about your health, including medications you take and any surgical procedures you have had. You may also have to fill out certain forms or have the following exams, tests or procedures. The screening process usually takes 2-3 hours.
You will be required to come for 7-9 visits including the initial screening for eligibility to participate in this study. The experiments will measure your brain perfusion, vascular function and exercise capacity.
An overview of the Baseline study procedures is as follows:
- Visit 1--Informed consent, medical history and physical examination,24 hour blood pressure, physical activity, quality of life questionnaires and Cognitive Evaluation. Texas Health Presbyterian Hospital Dallas IEEM. 2-3 hours.
- Visit 2--Overview Day to discuss cognitive scoring, review ABPM and Actical results, Physical function, CHAMPS, Mold of cranial artery. Texas Health Presbyterian Hospital Dallas IEEM 2 hours.
- Visit 3--Vascular function Texas Health Presbyterian Hospital Dallas IEEM. 3-4 hours.
- Visit 4--Physical and exercise testing. Texas Health Presbyterian Hospital Dallas IEEM. 3-4 hours.
- Visit 5--Dynamic and static cerebral auto-regulation. Texas Health Presbyterian Hospital Dallas IEEM. 3-4 hours.
- Visit 6--Brain function tests. UTSW Clinical Neuro-psychology Laboratory. 2-3 hours
- Visit 7--Dynamic and static cerebral auto-regulation with medication. Texas Health Presbyterian Hospital Dallas IEEM. 4 hours.
---------The last 2 visits are only for the Memory Impairment Group---------
- Visit 8--Positron-Emission Tomography (PET) Scans. UTSW PET imaging Center. 1-2 hours
- Visit 9--Exercise Training Day. Texas Health Presbyterian Hospital Dallas IEEM.1-2 hours.
For the healthy controls, the expected length of this study will be about 2-3 months including all the test visits. Your participation in this study will end following completion of your testing.
For those with Mild Cognitive Impairment, the expected length of this study will be about 18 months including all the test visits and exercise training. Your participation in this study will end following completion of your repeat testing after one-year exercise training or control intervention. On occasion, training may be delayed due to injury, illness or personal matters. If this is the case, your enrollment in the study may last longer than one year as we attempt to complete the training and testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146717
|Contact: Candace Hill, BSN||214.345.4665||CandaceHill@TexasHealth.org|
|United States, Texas|
|UT Southwestern ADC/Institute for Exercise and Environmental Medicine||Recruiting|
|Dallas, Texas, United States, 75231|
|Contact: Candace Hill, BSN 214-345-4665 CandaceHill@texashealth.org|
|Principal Investigator: Rong Zhang, PhD|
|Principal Investigator:||Rong Zhang, PhD||UTSW|