Ignite Creation Date:
2024-05-05 @ 11:42 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01392391
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2011-07-11
Brief Title:
Exercise For Sub-acute Stroke Patients in Jamaica
Sponsor:
Baltimore VA Medical Center
Organization:
Baltimore VA Medical Center
Study Overview
Official Title:
Jamaica and Maryland Mobility in Stroke
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JAMMS
Brief Summary:
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
Detailed Description:
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 mechanisms 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 3xweek TEXT or control group with best medical care alone that includes American Stroke Association ASA physical activity guideline recommendations for walking 4xweek 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
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 mechanisms 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 3xweek TEXT or control group with best medical care alone that includes American Stroke Association ASA physical activity guideline recommendations for walking 4xweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD068712 | NIH | None | httpsreporternihgovquickSearchR01HD068712 |