Trial of Aerobic Exercise Training in Stroke Survivors

Baltimore VA Medical Center

Status

Completed

Conditions

Stroke

Insulin Resistance

Sedentary Lifestyle

Treatments

Behavioral: Aerobic Exercise

Behavioral: Stretching

Study type

Interventional

Funder types

Other U.S. Federal agency

NIH

Identifiers

NCT00891514

AG0118

R01AG030075 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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