Status:
COMPLETED
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke.
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Stroke
Eligibility:
All Genders
40-85 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 S...
Eligibility Criteria
Inclusion
- Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- 85 yrs. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-85 years.
- Residual hemiparetic gait deficits.
- Already completed all conventional inpatient and outpatient physical therapy.
- Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)
Exclusion
- Already performing aerobic exercise 3 X / week.
- Increased alcohol consumption.
- Cardiac history of:
- unstable angina,
- recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II-IV);
- hemodynamically significant valvular dysfunction.
- Medical History:
- recent hospitalization (less than 3 months) for severe medical disease,
- PAOD with claudication,
- orthopedic or chronic pain condition restricting exercise, pulmonary or renal failure,
- active cancer,
- untreated poorly controlled hypertension measured on at least 2 occasions ( greater than160/100) or diabetes mellitus (fasting glucose greater than 180 mg/dl, HgA1C greater than 10%) unable to be controlled medically within 3 months; g) Anemia defined by hematocrit less than 30 . (5) Neurological history of
- dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist,
- severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands,
- hemiparetic gait from a prior stroke preceding the index stroke defining eligibility,
- non-stroke neuromuscular disorder restricting exercise (e.g. Parkinson's Syndrome),
- untreated major depression. (6) BMI \> 40.
- Special fMRI
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00430456
Start Date
August 1 2006
End Date
June 1 2012
Last Update
June 12 2012
Active Locations (1)
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1
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201