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Trial of Aerobic Exercise Training in Stroke Survivors

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ClinicalTrials.gov Identifier: NCT00891514
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Alice S. Ryan, PhD, Baltimore VA Medical Center

April 30, 2009
May 1, 2009
October 11, 2018
September 1, 2009
July 31, 2018   (Final data collection date for primary outcome measure)
VO2peak [ Time Frame: Baseline and 6 months ]
maximal oxygen consumption during a treadmill test
  • TNFalpha (tumor necrosis factor alpha), adiponectin in adipose tissue and skeletal muscle [ Time Frame: Baseline and 6 months ]
  • Whole body insulin sensitivity [ Time Frame: Baseline and 6 months ]
  • VO2peak (maximal oxygen consumption) [ Time Frame: Baseline and 6 months ]
  • Muscle insulin signaling proteins [ Time Frame: Baseline and 6 months ]
Complete list of historical versions of study NCT00891514 on ClinicalTrials.gov Archive Site
  • Whole body insulin sensitivity [ Time Frame: Baseline and 6 months ]
    glucose utilization during a glucose clamp
  • Cytokines [ Time Frame: Baseline and 6 months ]
    circulating TNF alpha levels
  • Body fat [ Time Frame: Baseline and 6 months ]
    whole body percent fat
  • Muscle mass [ Time Frame: Baseline and 6 months ]
    whole body lean mass
  • Circulating cytokines [ Time Frame: Baseline and 6 months ]
  • Glucose [ Time Frame: Baseline and 6 months ]
  • Insulin areas under the curve by Oral Glucose Tolerance Test [ Time Frame: Baseline and 6 months ]
  • Body composition (total body fat, visceral fat, subcutaneous abdominal fat, mid-thigh low density lean tissue) [ Time Frame: Baseline and 6 months ]
  • Muscle triglyceride content [ Time Frame: Baseline and 6 months ]
  • Number of macrophages [ Time Frame: Baseline and 6 months ]
Not Provided
Not Provided
 
Trial of Aerobic Exercise Training in Stroke Survivors
Aging, Inflammation and Exercise in Chronic Stroke
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stroke
  • Insulin Resistance
  • Sedentary Lifestyle
  • 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
  • Behavioral: Stretching
    Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months
  • Experimental: Aerobic Exercise
    Treadmill training
    Intervention: Behavioral: Aerobic Exercise
  • Active Comparator: Stretch Control
    Stretching exercises
    Intervention: Behavioral: Stretching

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
150
July 31, 2018
July 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00891514
AG0118
R01AG030075 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Alice S. Ryan, PhD, Baltimore VA Medical Center
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
Baltimore VA Medical Center
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP