Exercise For Sub-acute Stroke Patients in Jamaica (JAMMS)
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|ClinicalTrials.gov Identifier: NCT01392391|
Recruitment Status : Recruiting
First Posted : July 12, 2011
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Procedure: Task Oriented Exercise Training Procedure: Stroke Care "Get with the Guidelines"||Phase 2|
Stroke leads to profound cardiovascular deconditioning and secondary abnormalities in paretic skeletal muscle that worsen cardiovascular health. Conventional rehabilitation focuses on restoration of daily function, without an adequate exercise stimulus to address deconditioning or the muscle abnormalities that may propagate insulin resistance (IR) to worsen risk for type 2 diabetes mellitus (T2DM) and recurrent stroke. By the time individuals reach chronic stroke (>6 months), we report hemiparetic body composition abnormalities including paretic leg muscular atrophy, increased intramuscular area fat, and a major shift to fast myosin heavy chain (MHC). All of these factors promote IR, which has been linked to reduced muscle protein synthesis in aging that may be reversible with exercise. We also find elevated tumor necrosis factor alpha (TNFα) in paretic leg muscle, suggesting that inflammation may affect protein synthesis and breakdown, similar to sarcopenia in aging. Yet, no prior studies have considered stroke as a catabolic syndrome modifiable by early exercise to improve muscle and cardiometabolic health.
Aim #1. Paretic (P) and non-paretic (NP) leg mixed muscle protein synthesis and breakdown in the fed and fasted state, TNFα expression, thigh muscle volume and strength.
Hypothesis 1: Paretic leg has reduced muscle protein synthesis and increased breakdown compared to non-paretic leg; TEXT will increase mixed muscle protein synthesis and reduce breakdown to increase muscle volume and strength by the mechanism(s) of reducing inflammation in the paretic leg, compared to controls.
Aim # 2. Glucose tolerance, fitness, and muscle phenotype. Hypothesis 2: TEXT will improve fitness levels, insulin and glucose response to oral glucose challenge, and increase paretic leg slow twitch (slow MHC) muscle molecular phenotype.
This randomized study investigates the hypothesis that in African-Jamaican adults with recent hemiparetic stroke, 6 months of TEXT across the sub-acute and into the chronic phase of stroke will improve paretic leg muscle and cardiometabolic health, compared to controls receiving best medical care.
Phase 1 consists of recruitment and screening of individuals with mild to moderate hemiparetic stroke from UWI Accident and Emergency Room and Neurology Stroke Clinics. Phase 2: Subjects with hemiparetic gait ≤ 8 weeks post-stroke who are not wheelchair bound or bed are approached for informed consent, medical, neurologic, blood tests, and treadmill (TM) exercise tests to determine study eligibility. Phase 3 baseline testing includes measures of fitness, oral glucose tolerance test (OGTT), body composition, bilateral vastus lateralis muscle biopsies, stable isotope measures of protein synthesis and breakdown. Phase 4: Eligible subjects are randomized to 6 months 3x/week TEXT or control group with best medical care alone that includes American Stroke Association (ASA) physical activity guideline recommendations for walking 4x/week. Randomization is stratified based on glucose tolerance (normal vs. abnormal) and gait deficit severity. Subjects have limited 3 month testing of fitness levels (VO2 peak), body composition, fasting glucose and insulin levels to document the natural history (controls) and temporal profile of exercise-mediated adaptations (TEXT) as they transition from the sub-acute into chronic phase of stroke. Phase 5 is 6-month post-intervention testing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Jamaica and Maryland Mobility in Stroke|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Task-oriented exercise training (aerobic, strength, and balance exercises)
Procedure: Task Oriented Exercise Training
Treadmill training with safety harnesses begin at 6 to 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 30 minutes for 6 months.
Group dynamic balance exercise immediately follow the treadmill training 3 times a week. Participants also receive Best Stroke Care according to "Get with the Guidelines"
Active Comparator: Stroke Care
Best Medical Care in Jamaica adapted from the American Stroke Association "Get with the Guidelines".
Procedure: Stroke Care "Get with the Guidelines"
Post-stroke care is applied according to the recommendations of the American Stroke Association "Get with the Guidelines" adapted for Jamaica
- Thigh and Abdominal muscle and fat [ Time Frame: Baseline and 6 months ]CT scans to determine 1) mid-thigh cross sectional area for muscle area, intramuscular and subcutaneous fat area, and quality of lean tissue mass, 2) abdominal fat area.
- Whole body protein and skeletal muscle synthesis and breakdown [ Time Frame: Baseline and 6 months ]Serial blood sampling and pre-/post-muscle biopsies in the fasted and fed state
- Muscle myosin heavy chain isoform (MHC) proportions [ Time Frame: Baseline and 6 months ]Analysis of muscle biopsies for MHC fiber type proportions
- Leg Strength [ Time Frame: Baseline and 6 months ]1 repetitive maximum strength for leg extension, quadriceps and hamstring muscles
- Fitness [ Time Frame: Baseline and 6 months ]VO2 peak testing with open circuit spirometry
- Glucose tolerance [ Time Frame: Baseline and 6 months ]2 hour oral glucose tolerance test with serial blood sampling every 30 minutes for glucose and insulin
- Muscle TNF alpha [ Time Frame: Baseline and 6 months ]Analysis of muscle biopsy samples for TNF levels
- Mobility and balance [ Time Frame: Baseline and 6 months ]Stroke deficit profile will be indexed by NIH Stroke Scale, modified Ashworth, timed walks, Short Physical Performance Battery, Berg Balance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392391
|Contact: Richard F Macko, MDfirstname.lastname@example.org|
|Contact: Terrence Forrester, MDemail@example.com|
|United States, Maryland|
|University of Maryland||Active, not recruiting|
|Baltimore, Maryland, United States, 21201|
|University of West Indies||Recruiting|
|Kingston, Mona 7, Jamaica|
|Contact: Terrence Forrester, MD 876-7024687 firstname.lastname@example.org|
|Contact: Sandra Boynes 876-927-1884 email@example.com|
|Principal Investigator: Terrence Forrester, MD|
|Sub-Investigator: Sandra Boynes|
|Principal Investigator:||Richard F Macko, MD||University of Maryland|
|Principal Investigator:||Terrence Forrester, MD||University of West Indies|