Dose Response Study of Exercise for Age-related Cognitive Changes
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| City: |
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Kansas City |
| State: |
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Kansas |
| Zip Code: |
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66160 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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This is a randomized, 26-week study of supervised exercise assessing three doses of exercise
in sedentary individuals 65 years of age and over with age-related cognitive changes. A
total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic
control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic
exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%,
100%, or 150% of the recommended exercise dose. Participants will be directly supervised
during all exercise sessions for the first two months after which direct supervision will
occur during at least one session a week. This is intended to provide increased flexibility
while also maintaining direct contact with the participant to enhance adherence. Aerobic
fitness, physical function, and cognition will be assessed at baseline and 26 weeks to
examine the dose-response relationships. At 52 weeks, cognition will be reassessed to
examine durability of cognitive changes.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Informed consent
- Age 65 years or older
- Underactive or sedentary based on the Telephone Assessment of Physical Activity
- Community dwelling with a caregiver willing to accompany the participant to visits to
the screening evaluation. The caregiver must visit with the subject more than five
times a week.
- Nondemented: CDR 0
- Adequate visual and auditory abilities to perform all aspects of the cognitive and
functional assessments
- Stable doses of medications for at least 30 days prior to screening.
- Likely to participate in all scheduled evaluations and complete the exercise program
over 52 weeks
Exclusion Criteria:
- Dementia
- CDR > 0
- Current clinically significant major psychiatric disorder (e.g., Major Depressive
Disorder) according to DSM-IV criteria or Geriatric Depression score of 5 or greater.
- Significant psychiatric symptoms (e.g., hallucinations) that could impair the
completion of the study
- Current clinically-significant systemic illness likely to result in deterioration of
the patient's condition or affect the patient's safety during the study
- History of clinically-evident stroke
- Clinically-significant infection within the last 30 days
- Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the
last two-years.
- Uncontrolled hypertension within the last 6 months
- History of cancer within the last 5 years (except non-metastatic basal or squamous
cell carcinoma)
- History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2
years
- Insulin-dependent diabetes mellitus
- Significant pain or musculoskeletal disorder that would prohibit participation in an
exercise program
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| NCT ID: |
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NCT01129115 |
| Primary Contact: |
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Principal Investigator
Jeffrey Burns, MD
University of Kansas
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| Backup Contact: |
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N/A |
| Location Contact: |
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Kansas City, Kansas 66160
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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