Inflammation and Exercise in Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00891514
First received: April 30, 2009
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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 Intervention
Stroke
Insulin Resistance
Sedentary Lifestyle
Behavioral: Aerobic Exercise
Behavioral: Stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aging, Inflammation and Exercise in Chronic Stroke

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • TNFalpha (tumor necrosis factor alpha), adiponectin in adipose tissue and skeletal muscle [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Whole body insulin sensitivity [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • VO2peak (maximal oxygen consumption) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Muscle insulin signaling proteins [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circulating cytokines [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Insulin areas under the curve by Oral Glucose Tolerance Test [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Body composition (total body fat, visceral fat, subcutaneous abdominal fat, mid-thigh low density lean tissue) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Muscle triglyceride content [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Number of macrophages [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treadmill
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: 2
Stretch
Behavioral: Stretching
Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891514

Contacts
Contact: Jessica Hammers 410-605-7000 ext 4842 jhammers@grecc.umaryland.edu

Locations
United States, Maryland
University of Maryland, VAMC Recruiting
Baltimore, Maryland, United States, 20705
Contact: Alice S. Ryan, PhD    410-605-7851    aryan@grecc.umaryland.edu   
Contact: Jessica Hammers    410-605-7000 ext 4842    jhammers@grecc.umaryland.edu   
Principal Investigator: Alice S. Ryan, PhD         
Sub-Investigator: Charlene Hafer-Macko, MD         
Sponsors and Collaborators
Investigators
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
  More Information

Publications:
Responsible Party: Alice S. Ryan, PhD, University of Maryland, VA Research Service
ClinicalTrials.gov Identifier: NCT00891514     History of Changes
Other Study ID Numbers: AG0118, RO1 AG030075
Study First Received: April 30, 2009
Last Updated: September 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Exercise
Inflammation
Insulin Sensitivity

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Stroke
Cerebral Infarction
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014