Macko 2013

Trial name or title	Exercise for sub‐acute stroke patients in Jamaica
Methods	Method: RCT, parallel assignment Method of randomisation: stratified based on glucose tolerance (normal versus abnormal) and gait deficit severity Blinding of outcome assessors: no ITT: unclear
Participants	Country: Jamaica 150 people with chronic stroke Ambulatory at study onset: unclear Inclusion criteria: ischaemic stroke within 2 months; BMI of 18 to 40 kg/m²; being able to walk 3 minutes with handrails, assistive device or stand‐by aid Exclusion criteria: actively exercising for > 30 minutes per day for 5 days per week; increased alcohol consumption; active abuse of other illegal and illicit drugs; history of severe cardiac conditions; history of (1) peripheral arterial disease with vascular claudication making exercise challenging, (2) orthopaedic or chronic pain condition(s) restricting exercise, (3) pulmonary or renal failure, (4) active cancer, (5) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100), (6) HIV‐AIDS or other known inflammatory responses, (7) sickle cell anaemia, (8) medications: heparin, warfarin, Lovenox or oral steroids, (9) currently pregnant, (10) history of type 1 diabetes or insulin dependent type 2 diabetes, (11) poorly controlled type 2 diabetes (HbA1C > 10), (12) dementia (MMSE score < 23 or < 17 if education level at or below 8th grade) and clinical confirmation by clinical evaluation, (13) severe receptive or global aphasia that confounds testing and/or training, operationally defined as unable to follow 2 point commands, (14) hemiparetic gait from a prior stroke preceding the index stroke defining eligibility (more than one stroke), (15) neurologic disorder restricting exercise such as Parkinson's or myopathy, (16) untreated major depression (CES‐D > 16 or clinical confirmation), (17) muscular disorder (s) restricting exercise; muscle biopsy exclusion criteria: (1) anticoagulation therapy with heparin, warfarin or Lovenox (antiplatelet therapy is permitted), (2) bleeding disorder
Interventions	2 arms: CTL group will receive best medical stroke care "Get with the guidelines" for Jamaica for 6 months EXP group, in addition to the control intervention, will receive treadmill training for 6 months, 3 times per week (18 to 90 minutes per week) and group dynamic balance exercise
Outcomes	Outcomes will be assessed at baseline and at the end of the intervention phase at 6 months: Primary outcomes: thigh and abdominal muscle and fat whole body protein and skeletal muscle synthesis and breakdown (serial blood sampling and pre‐/post‐muscle biopsies in the fasted and fed state) muscle myosin heavy chain isoform (MHC) proportions (muscle biopsy) leg strength (1 repetitive maximum strength for leg extension, quadriceps and hamstring muscles) fitness (VO2 peak testing with open circuit spirometry) glucose tolerance (2‐hour oral glucose tolerance test with serial blood sampling every 30 minutes for glucose and insulin) Secondary outcomes: muscle TNF alpha (muscle biopsy) mobility and balance (National Institutes of Health Stroke Scale, modified Ashworth, timed walks, Short Physical Performance Battery, Berg Balance Scale)
Starting date	July 2011
Contact information	Richard F Macko, MD Email: rmacko@grecc.umaryland.edu
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