Status:
COMPLETED
Trial of Aerobic Exercise Training in Stroke Survivors
Lead Sponsor:
Baltimore VA Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Stroke
Insulin Resistance
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effects of treadmill training on inflammation in the skeletal muscle and adipose tissue, insulin action in the skeletal muscle, and whole body glucose metab...
Detailed Description
Many stroke survivors are sedentary and are at risk for the development of diabetes. We will study the interactions of adipose tissue and the paretic and non-paretic muscle inflammation, insulin signa...
Eligibility Criteria
Inclusion
- Ischemic or hemorrhagic stroke greater than or equal to 6 months prior with stable residual hemiparetic gait deficits
- Already completed all conventional inpatient and outpatient physical therapy
- Adequate language and neurocognitive function to safely participate in exercise testing and training
- Men or women ages 40-75 years
- Body mass index between 20 to 50 kg/m2
- Non-smoker, or history of no smoking for more than 5 years
- Under the care of a primary care medical provider
Exclusion
- Already performing aerobic exercise 3 times a week
- Increased alcohol consumption defined as greater than 2 oz. liquor or 8 oz. of wine or 24 oz. of beer per day
- Cardiac history of:
- unstable angina
- recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure
- hemodynamically significant valvular dysfunction
- Medical History:
- recent hospitalization (less than 3 months prior to study entry) for severe medical disease
- peripheral arterial disease with vascular 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 than 160/100)
- type I diabetes mellitus, insulin therapy, untreated and/or poorly controlled diabetes with fasting blood glucose of greater than 160
- smoking within the last 5 years
- allergy to lidocaine
- medications: heparin, warfarin, lovenox, beta-blockers, oral steroids
- 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 (more than one stroke)
- neurologic disorder restricting exercise, such as Parkinsons Syndrome or myopathy
- untreated major depression
- Adipose tissue and muscle biopsy exclusion criteria:
- anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
- bleeding disorder
- allergy to lidocaine
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00891514
Start Date
September 1 2009
End Date
July 31 2018
Last Update
October 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland, VAMC
Baltimore, Maryland, United States, 20705