Exercise For Sub-acute Stroke Patients in Jamaica
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 09/30/2016 |
| Iliyowasilishwa Kwanza: | 07/10/2011 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 07/10/2011 |
| Iliyotumwa Kwanza: | 07/11/2011 |
| Sasisho la Mwisho Liliwasilishwa: | 10/27/2016 |
| Sasisho la Mwisho Lilichapishwa: | 10/31/2016 |
| Tarehe halisi ya kuanza kwa masomo: | 06/30/2011 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 03/31/2018 |
| Tarehe ya Kukamilisha Utafiti: | 03/31/2018 |
Hali au ugonjwa
Uingiliaji / matibabu
Procedure: Exercise
Procedure: Stroke Care
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Exercise Task-oriented exercise training (aerobic, strength, and balance exercises) | Procedure: Exercise 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 Post-stroke care is applied according to the recommendations of the American Stroke Association "Get with the Guidelines" adapted for Jamaica |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Ischemic stroke within 8 weeks - BMI of 18-40 kg/m2 - Able to walk 3 minutes with handrails, assistive device, or standby aid Exclusion Criteria: - 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Thigh and Abdominal muscle and fat [Baseline and 6 months]
2. Whole body protein and skeletal muscle synthesis and breakdown [Baseline and 6 months]
3. Muscle myosin heavy chain isoform (MHC) proportions [Baseline and 6 months]
4. Leg Strength [Baseline and 6 months]
5. Fitness [Baseline and 6 months]
6. Glucose tolerance [Baseline and 6 months]
Hatua za Matokeo ya Sekondari
1. Muscle TNF alpha [Baseline and 6 months]
2. Mobility and balance [Baseline and 6 months]
