Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT)
Status and phase
Conditions
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Study type
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Identifiers
Details and patient eligibility
About
The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- age 55-75 years (inclusive)
- English-speaking
- sufficient visual and auditory perception to complete testing
- available informant (someone who knows the individual well)
- Clinical Dementia Rating of 0 (non-demented per the screening assessment).
Exclusion criteria
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participation in a regular exercise program in last 6 months
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participation in a cognitive training program in last 6 months
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inability to walk on a treadmill or ride an exercise bike
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less than a 10th grade education
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mild cognitive impairment or dementia
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cigarette smoking within the previous year
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history of alcohol or substance abuse
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BMI greater than 35
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insulin-dependent diabetes
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major and/or unstable medical, neurological, or psychiatric disorder, including:
- active congestive heart failure
- unstable angina
- effort angina
- nocturnal angina
- MI within previous 6 months
- ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected by ST-segment depression of 0.3 mm
- resting blood pressure above 170 systolic or 100 diastolic
- chronic infections
- advanced arthritis
- contractures or weakness due to CVA that would prevent adequate performance of the exercises.
- disabling stroke
- late stage renal or liver disease
- major affective disorder with active symptoms
Trial design
Primary purpose
Allocation
Interventional model
Masking
96 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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