Trial of Aerobic Exercise Training in Stroke Survivors

Recruiting

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Aerobic Exercise Other
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: 1
    Description: Treadmill
    ARM 2: Kind: Experimental
    Label: Aerobic Exercise
    Description: Treadmill training
  • Stretching Behavioral
    Intervention Desc: Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months
    ARM 1: Kind: Experimental
    Label: 2
    Description: Stretch
    ARM 2: Kind: Experimental
    Label: Stretch Control
    Description: Stretching exercises

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary TNFalpha (tumor necrosis factor alpha), adiponectin in adipose tissue and skeletal muscle Baseline and 6 months No
Primary Whole body insulin sensitivity Baseline and 6 months No
Primary VO2peak (maximal oxygen consumption) Baseline and 6 months No
Primary Muscle insulin signaling proteins Baseline and 6 months No
Secondary Circulating cytokines Baseline and 6 months No
Secondary Glucose Baseline and 6 months No
Secondary Insulin areas under the curve by Oral Glucose Tolerance Test Baseline and 6 months No
Secondary Body composition (total body fat, visceral fat, subcutaneous abdominal fat, mid-thigh low density lean tissue) Baseline and 6 months No
Secondary Muscle triglyceride content Baseline and 6 months No
Secondary Number of macrophages Baseline and 6 months No
Primary VO2peak Baseline and 6 months
Secondary Cytokines Baseline and 6 months
Secondary Body fat Baseline and 6 months
Secondary Muscle mass Baseline and 6 months

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