Aerobic Exercise Training in Mild Cognitive Impairment
Aerobic Exercise Training in Mild Cognitive Impairment
Overall Status:
Recruiting
Brief Description:
The purpose of this study is to find out whether brain blood flow is altered in patients with mild cognitive impairment (MCI), a condition characterized by memory problems greater than normal for one's age but otherwise good health. In addition, this study will determine whether exercise training improves brain blood flow and brain function in patients with MCI.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 80 Years | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Absence of cognitive complaints and normal performance in Uniform Data Set (UDS) neuropsychological tests
- Diagnosis of amnestic MCI
- Stable medical condition for more than 6 months
- Stable medications for more than 2 months (use of cholinesterase inhibitors or prior use of multivitamins is allowed)
- Caregiver/informant available to accompany patient for scheduled visits
- Fluency in English of patient and caregiver
- Ten years or more of education or enough work history to exclude mental retardation
- Adequate visual and auditory acuity to allow neuropsychological testing
- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study
- Physical ability to undergo endurance exercise training
Exclusion Criteria:
- Diagnosis of Alzheimer's disease or other type of dementia
- Participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
- Modified Hachinski Score of 4 or greater
- History in past 2 years of epileptic seizures or any major psychiatric disorder
- Past history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder
- Carotid stent or sever stenosis
- Significant history of alcoholism or drug abuse
- History of myocardial infarction within previous year
- Unstable cardiac, renal, lung, liver, or other severe chronic disease
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg) or hypotension (systolic blood pressure <100 mmHg)
- Currently being treated for diabetes mellitus
- Obesity with body mass index of 35 or more
- History of familial early-onset dementia (less than 55 years old)
- Pacemaker or other medical metal device that precludes performing MRI
- Engagement in moderate-intensity aerobic exercise training for more than 30 minutes, 3 times per week, during past 2 years
- History of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
- Chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatica
Detailed Description:
Investigators plan to screen 144 patients with MCI and 60 control subjects in order to enroll 204 participants in this clinical trial. Participants will be required to make seven to nine visits, including an initial screening for eligibility to participate in the study. The experiments will measure brain blood flow, vascular function, and exercise capacity.
For those with MCI, the expected length of the study will be about 18 months, including all test visits and exercise training. Participation will end following completion of repeat testing after 1 year of moderate-intensity exercise training or control intervention of flexibility and balance training. For healthy controls, participation will last about 2-3 months, including all test visits.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 32.8798071, -96.7547522 | UT Southwestern ADC/Institute for Exercise and Environmental Medicine | Dallas | Texas | 75231 | Recruiting |
Lead Sponsor:
| Agency |
|---|
University of Texas Southwestern Medical Center |
Collaborator Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Rong Zhang, PhD | Principal Investigator | UTSW |
Study Contact:
| Name | Phone | |
|---|---|---|
Candace Hill | 214-345-4665 |
Locations
ClinicalTrials.gov ID
NCT01146717 (follow link to view full record on ct.gov in new window)
Official Title:
Mild Cognitive Impairment: Cerebrovascular Dysfunction and Exercise
Study Start Date:
March 2010
Study End Date:
October 2015
Enrollment:
204
