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Trial of Aerobic Exercise Training in Stroke Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00891514
Recruitment Status : Recruiting
First Posted : May 1, 2009
Last Update Posted : July 17, 2017
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Alice S. Ryan, PhD, Baltimore VA Medical Center

Brief Summary:
The purpose of this study is to examine the effects of treadmill training on inflammation in the skeletal muscle and adipose tissue, insulin action in the skeletal muscle, and whole body glucose metabolism in stroke survivors. The fundamental hypothesis of this study is that key inflammatory markers in adipose tissue and skeletal muscle are abnormal, skeletal muscle insulin signaling is impaired, and systemic insulin sensitivity is reduced in hemiparetic stroke patients and that these factors are modifiable and improved by exercise training in stroke patients.

Condition or disease Intervention/treatment
Stroke Insulin Resistance Sedentary Lifestyle Behavioral: Aerobic Exercise Behavioral: Stretching

Detailed Description:

Many stroke survivors are sedentary and are at risk for the development of diabetes. We will study the interactions of adipose tissue and the paretic and non-paretic muscle inflammation, insulin signaling and action in hemiparetic stroke patients and the ability to employ exercise training to reverse these abnormalities in this ethnically diverse population. Participants aged 40-75 years with chronic stroke will be randomized to treadmill training versus stretch control group using a one-two-one blocked randomization on race (black vs. white), sex (male vs. female), and glucose tolerance status (normal vs. impaired and type 2 diabetes).

Stroke occurs in over 780,000 persons each year in the U.S., the vast majority reported in persons older than 55 years of age. Following stroke, patients remain at continued high risk for recurrent stroke. Inflammatory processes lead to cardiovascular events/stroke and contribute to disease risk progression by impacting insulin resistance and the development of type 2 diabetes. Interventions that reduce inflammation and improve insulin sensitivity have important clinical implications, especially in the stroke population.

Task-oriented treadmill training is utilized to improve cardiovascular fitness and functional mobility in hemiparetic stroke patients. Additionally, preliminary data indicates that progressive treadmill training in this population improves glucose tolerance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aging, Inflammation and Exercise in Chronic Stroke
Actual Study Start Date : September 2009
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aerobic Exercise
Treadmill training
Behavioral: Aerobic Exercise
Treadmill training- begins at 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 45-60 minutes for 6 months
Active Comparator: Stretch Control
Stretching exercises
Behavioral: Stretching
Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months

Primary Outcome Measures :
  1. VO2peak [ Time Frame: Baseline and 6 months ]
    maximal oxygen consumption during a treadmill test

Secondary Outcome Measures :
  1. Whole body insulin sensitivity [ Time Frame: Baseline and 6 months ]
    glucose utilization during a glucose clamp

  2. Cytokines [ Time Frame: Baseline and 6 months ]
    circulating TNF alpha levels

  3. Body fat [ Time Frame: Baseline and 6 months ]
    whole body percent fat

  4. Muscle mass [ Time Frame: Baseline and 6 months ]
    whole body lean mass

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke greater than or equal to 6 months prior with stable residual hemiparetic gait deficits
  • Already completed all conventional inpatient and outpatient physical therapy
  • Adequate language and neurocognitive function to safely participate in exercise testing and training
  • Men or women ages 40-75 years
  • Body mass index between 20 to 50 kg/m2
  • Non-smoker, or history of no smoking for more than 5 years
  • Under the care of a primary care medical provider

Exclusion Criteria:

  • Already performing aerobic exercise 3 times a week
  • Increased alcohol consumption defined as greater than 2 oz. liquor or 8 oz. of wine or 24 oz. of beer per day
  • Cardiac history of:

    1. unstable angina
    2. recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure
    3. hemodynamically significant valvular dysfunction
  • Medical History:

    1. recent hospitalization (less than 3 months prior to study entry) for severe medical disease
    2. peripheral arterial disease with vascular claudication
    3. orthopedic or chronic pain condition restricting exercise
    4. pulmonary or renal failure
    5. active cancer
    6. untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100)
    7. type I diabetes mellitus, insulin therapy, untreated and/or poorly controlled diabetes with fasting blood glucose of greater than 160
    8. smoking within the last 5 years
    9. allergy to lidocaine
    10. medications: heparin, warfarin, lovenox, beta-blockers, oral steroids
  • Neurological history of:

    1. dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist
    2. severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands
    3. hemiparetic gait from a prior stroke preceding the index stroke defining eligibility (more than one stroke)
    4. neurologic disorder restricting exercise, such as Parkinsons Syndrome or myopathy
    5. untreated major depression
  • Adipose tissue and muscle biopsy exclusion criteria:

    1. anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
    2. bleeding disorder
    3. allergy to lidocaine

Information from the National Library of Medicine

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 identifier (NCT number): NCT00891514

Contact: Lynda Robey, MS 410-605-7000 ext 5446

United States, Maryland
University of Maryland, VAMC Recruiting
Baltimore, Maryland, United States, 20705
Contact: Alice S. Ryan, PhD    410-605-7851   
Contact: Jessica Hammers    410-605-7000 ext 4842   
Principal Investigator: Alice S. Ryan, PhD         
Sub-Investigator: Charlene Hafer-Macko, MD         
Sponsors and Collaborators
Baltimore VA Medical Center
National Institute on Aging (NIA)
Principal Investigator: Alice S. Ryan, PhD University of Maryland, VA Research Service
Principal Investigator: Charlene Hafer-Macko, MD University of Maryland, VA Research Service, Department of Neurology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alice S. Ryan, PhD, Professor, Baltimore VA Medical Center Identifier: NCT00891514     History of Changes
Other Study ID Numbers: AG0118
R01AG030075 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Alice S. Ryan, PhD, Baltimore VA Medical Center:
Insulin Sensitivity

Additional relevant MeSH terms:
Insulin Resistance
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases