Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to disease. This worsens disability and can increase the risk of having another stroke or a heart attack. We would like to find out if and how different types of regular exercise (intense walking, long walking) can increase fitness, balance and improve walking function and activities of daily living in individuals who have suffered a stroke.
This randomized study compares effects of duration vs. velocity-based TM training regimens on fitness and ambulatory function in chronic stroke patients. Phase 1 - patients are screened (Mini Mental Status, CESD for depression, alcohol intake survey) and undergo routine medical and CV evaluations and blood labs in VA RRDC Assessment Clinic to establish medical eligibility. Standard neurological evaluations (NIH Stroke Scale, Modified Asworth Spasticity Scale, range of motion and manual motor testing) and review of imaging records assess neurological eligibility, deficit profiles and stroke subtypes. Physician supervised treadmill tolerance test and peak effort constant velocity exercise stress test with vital signs monitoring determine treadmill safety, functional eligibility to participate (must walk 3 minutes at 0.2 MPH with handrail support), and cardiopulmonary safety in response to strenuous exertion. Eligible candidates undergo baseline testing (phase 2) including measures of fitness (VO2 peak, gait economy), ambulatory function and BOLD fMRI of knee movement. Phase 3 - 6 months TM training with either velocity or duration based progression, followed by Phase 4 -repeat of fitness and ambulatory function tests after 3 months, and Phase 5 - repeat of all baseline tests after 6 months training
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Treadmill Training
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States
Peak Aerobic Fitness
Time frame: 3 and 6 months
Economy of Gait
Time frame: 3 and 6 months
6 minute walk
Time frame: 3 and 6 months
Fastest Comfortable 10-meter walk
Time frame: 3 and 6 months
Self-Selected 10-meter walk
Time frame: 3 and 6 months
48-hour Step Activity Monitoring
Time frame: 3 and 6 months
Scales of Mobility, Function, Fatigue and Self-Efficacy
Time frame: 6 months
Neuroplasticity (BOLD fMRI)
Time frame: 6 months
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