Aerobic Exercise Training in Mild Cognitive Impairment Study (AETMCI)
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|ClinicalTrials.gov Identifier: NCT01146717|
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : October 26, 2016
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, brain structure, 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, brain structure, and brain function in patients with mild cognitive impairment.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Exercise Behavioral: Balance training||Phase 2|
We plan to study 70 patients with amnestic MCI and 30 healthy older adults with similar age, sex, and educational level 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mild Cognitive Impairment:Cerebrovascular Dysfunction and Exercise|
|Study Start Date :||March 2010|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
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.
- Cognitive function [ Time Frame: One year ]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 ]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 ]Magnetic resonance imaging (MRI) will be used to measure changes in brain volume and white matter integrity before and after exercise training.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146717
|United States, Texas|
|UT Southwestern ADC/Institute for Exercise and Environmental Medicine|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Rong Zhang, PhD||UTSW|