Exercise For Sub-acute Stroke Patients in Jamaica

Status unconfirmed · Phase 2

Conditions studied: Stroke

In brief

Chronic hemiparetic stroke is associated changes in body composition, skeletal muscle and cardiometabolic health; specific changes include paretic limb muscular atrophy, increased intramuscular fat deposition, elevated prevalence of impaired glucose tolerance and type 2 diabetes. This randomized intervention study compares a 6 month task oriented exercise programs versus control with both groups receiving best medical stroke care according to American Stroke Association "Get with the Guidelines". The hypothesis is that is 6 months of task-oriented exercise initiated early across the sub-acute period of stroke can prevent or ameliorate the natural course of these body composition, skeletal muscle and cardiometabolic health changes.

Key facts

Study ID

NCT01392391

Run by

Baltimore VA Medical Center

People needed

150

Starts

2011-07-01

Expected to finish

2018-04-01

Last updated by the study team

2016-11-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ischemic stroke within 8 weeks
• BMI of 18-40 kg/m2
• Able to walk 3 minutes with handrails, assistive device, or standby aid

You may not qualify if…

• Actively exercising for >30 minutes per day for 5 days per week
• Increased alcohol consumption (> 2 oz. liquor, 8 oz. wine, 24 oz. beer per day)
• Active abuse of other illegal and illicit drugs
• Cardiac History of: a) unstable angina, b) recent (<3 months) myocardial infarction, congestive heart failure (NYHA category II-IV), c) hemodynamically significant valvular dysfunction
• Medical History: a) peripheral arterial disease with vascular claudication making exercise challenging, b) orthopedic or chronic pain condition(s) restricting exercise, c) pulmonary or renal failure, d) active cancer, e) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100), f) HIV-AIDS or other known inflammatory responses, g) sickle cell anemia, h) medications: heparin, warfarin, lovenox, or oral steroids, j) currently pregnant
• Endocrine History: a) type 1 diabetes or insulin dependent type 2 diabetes, b) poorly controlled type 2 diabetes (HbA1C > 10)
• Neurological History: a) dementia (Mini-Mental Status score < 23 or < 17 if education level at or below 8th grade) and clinical confirmation by clinical evaluation, b) severe receptive or global aphasia that confounds testing and/or training, operationally defined as unable to follow 2 point commands, c) hemiparetic gait from a prior stroke preceding the index stroke defining eligibility (more than one stroke), d) neurologic disorder restricting exercise such as Parkinsons or myopathy, e) untreated major depression (CESD > 16 or clinical confirmation), f) muscular disorder (s) restricting exercise
• Muscle biopsy exclusion criteria: a) anti-coagulation therapy with heparin, warfarin, or lovenox (anit-platelet therapy is permitted), b)bleeding disorder

Where it is running

• University of West Indies — Kingston, Mona 7, Jamaica (enrolling)
• University of Maryland — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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