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Aging, Inflammation and Exercise in Chronic Stroke

40 Years
75 Years
Open (Enrolling)
Stroke, Insulin Resistance, Sedentary Lifestyle

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Trial Information

Aging, Inflammation and Exercise in Chronic Stroke

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.

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

TNFalpha (tumor necrosis factor alpha), adiponectin in adipose tissue and skeletal muscle

Outcome Time Frame:

Baseline and 6 months

Safety Issue:


Principal Investigator

Alice S. Ryan, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland, VA Research Service


United States: Federal Government

Study ID:




Start Date:

May 2009

Completion Date:

April 2014

Related Keywords:

  • Stroke
  • Insulin Resistance
  • Sedentary Lifestyle
  • Exercise
  • Inflammation
  • Insulin Sensitivity
  • Inflammation
  • Insulin Resistance
  • Stroke
  • Cerebral Infarction



University of Maryland, VAMC Baltimore, Maryland  20705