Exercise For Sub-acute Stroke Patients in Jamaica

NCT01392391 | Unknown Phase 2 DMC

• 2 other identifiers: HP-00048469R01HD068712
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stroke

Keywords

Stroke; Exercise; Protein synthesis; Protein breakdown; Muscle atrophy; Muscle phenotype; Inflammation; Insulin resistance; Fitness

Outcome Measures

Primary Outcomes (6)

• Thigh and Abdominal muscle and fat

  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.

  Baseline and 6 months

• Whole body protein and skeletal muscle synthesis and breakdown

  Serial blood sampling and pre-/post-muscle biopsies in the fasted and fed state

  Baseline and 6 months

• Muscle myosin heavy chain isoform (MHC) proportions

  Analysis of muscle biopsies for MHC fiber type proportions

  Baseline and 6 months

• Leg Strength

  1 repetitive maximum strength for leg extension, quadriceps and hamstring muscles

  Baseline and 6 months

• Fitness

  VO2 peak testing with open circuit spirometry

  Baseline and 6 months

• Glucose tolerance

  2 hour oral glucose tolerance test with serial blood sampling every 30 minutes for glucose and insulin

  Baseline and 6 months

Secondary Outcomes (2)

• Muscle TNF alpha

  Baseline and 6 months

• Mobility and balance

  Baseline and 6 months

Study Arms (2)

Exercise

EXPERIMENTAL

Task-oriented exercise training (aerobic, strength, and balance exercises)

Procedure: Task Oriented Exercise Training

Stroke Care

ACTIVE COMPARATOR

Best Medical Care in Jamaica adapted from the American Stroke Association "Get with the Guidelines".

Procedure: Stroke Care "Get with the Guidelines"

Interventions

Task Oriented Exercise Training PROCEDURE

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"

Exercise

Stroke Care "Get with the Guidelines" PROCEDURE

Post-stroke care is applied according to the recommendations of the American Stroke Association "Get with the Guidelines" adapted for Jamaica

Stroke Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

ACTIVE NOT RECRUITING

University of West Indies

Kingston, Mona 7, Jamaica

RECRUITING

Related Publications (3)

• Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133.

  PMID: 19581199 BACKGROUND

• Lam JM, Globas C, Cerny J, Hertler B, Uludag K, Forrester LW, Macko RF, Hanley DF, Becker C, Luft AR. Predictors of response to treadmill exercise in stroke survivors. Neurorehabil Neural Repair. 2010 Jul-Aug;24(6):567-74. doi: 10.1177/1545968310364059. Epub 2010 May 7.

  PMID: 20453154 BACKGROUND

• Luft AR, Macko RF, Forrester LW, Villagra F, Ivey F, Sorkin JD, Whitall J, McCombe-Waller S, Katzel L, Goldberg AP, Hanley DF. Treadmill exercise activates subcortical neural networks and improves walking after stroke: a randomized controlled trial. Stroke. 2008 Dec;39(12):3341-50. doi: 10.1161/STROKEAHA.108.527531. Epub 2008 Aug 28.

  PMID: 18757284 BACKGROUND

Related Links

• American Stroke Association
• University of West Indies Tropical Medicine Research Unit

MeSH Terms

Conditions

Stroke; Motor Activity; Muscular Atrophy; Inflammation; Insulin Resistance

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Richard F Macko, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Terrence Forrester, MD

  University of West Indies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard F Macko, MD

CONTACT

410-605-7063; rmacko@grecc.umaryland.edu

Terrence Forrester, MD

CONTACT

876-702-4687; terrence.forrester@uwimona.edu.jm

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

JA (1); US (1)