Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke. "STEPs"

Completed

Phase 1 Results N/A

Trial Description

Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to disease. This worsens disability and can increase the risk of having another stroke or a heart attack. We would like to find out if and how different types of regular exercise (intense walking, long walking) can increase fitness, balance and improve walking function and activities of daily living in individuals who have suffered a stroke.

Detailed Description

This randomized study compares effects of duration vs. velocity-based TM training regimens on fitness and ambulatory function in chronic stroke patients. Phase 1 - patients are screened (Mini Mental Status, CESD for depression, alcohol intake survey) and undergo routine medical and CV evaluations and blood labs in VA RRDC Assessment Clinic to establish medical eligibility. Standard neurological evaluations (NIH Stroke Scale, Modified Asworth Spasticity Scale, range of motion and manual motor testing) and review of imaging records assess neurological eligibility, deficit profiles and stroke subtypes. Physician supervised treadmill tolerance test and peak effort constant velocity exercise stress test with vital signs monitoring determine treadmill safety, functional eligibility to participate (must walk 3 minutes at 0.2 MPH with handrail support), and cardiopulmonary safety in response to strenuous exertion. Eligible candidates undergo baseline testing (phase 2) including measures of fitness (VO2 peak, gait economy), ambulatory function and BOLD fMRI of knee movement. Phase 3 - 6 months TM training with either velocity or duration based progression, followed by Phase 4 -repeat of fitness and ambulatory function tests after 3 months, and Phase 5 - repeat of all baseline tests after 6 months training

Conditions

Interventions

  • Exercise Program Behavioral
    Intervention Desc: Regular exercise program of stretching, intense walking, & long walking.
  • Exercise Other
    Intervention Desc: Treadmill Training
    ARM 1: Kind: Experimental
    Label: 1
    Description: Higher Intensity, Shorter Duration Treadmill Training
    ARM 2: Kind: Experimental
    Label: 2
    Description: Lower Intensity, Longer Duration Treadmill Training
    ARM 3: Kind: Experimental
    Label: Arm 1
    Description: Higher Intensity, Shorter Duration Treadmill Training
    ARM 4: Kind: Experimental
    Label: Arm 2
    Description: Lower Intensity, Longer Duration Treadmill Training

Trial Design

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

Patient Involvement

Patient will participate in exercise program as instructed. Patient will have fMRI, biomechanics testing, and blood work as scheduled.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cardiovascular fitness (VO2 peak), 10 meter walk time, 6 minute walk distance.
Secondary fMRI brain activity, gait biomechanics, ankle range of motion, thigh muscle/fat mass, muscle fiber type, step activity, insulin sensitivity, lipids, leg and brain blood flow, oxygen kinetics, social support, self efficacy, fatigue severity, quality of life.
Primary Peak Aerobic Fitness 3 and 6 months No
Secondary Economy of Gait 3 and 6 months No
Secondary 6 minute walk 3 and 6 months No
Secondary Fastest Comfortable 10-meter walk 3 and 6 months No
Secondary Self-Selected 10-meter walk 3 and 6 months No
Secondary 48-hour Step Activity Monitoring 3 and 6 months No
Secondary Scales of Mobility, Function, Fatigue and Self-Efficacy 6 months No
Secondary Neuroplasticity (BOLD fMRI) 6 months No

Sponsors