Testing Adaptive Physical Activity in Stroke "TAPAS"

Recruiting

Phase N/A Results N/A

Trial Description

"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are:
1. to determine whether APA improves cardiovascular fitness and metabolic health
2. to measure the effects of APA on gait and balance, ambulatory activity, and ADL function
3. to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life

Conditions

Interventions

  • Adaptive Physical Activity Other
    Intervention Desc: Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
    ARM 1: Kind: Experimental
    Label: Home Exercise Only
    Description: Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel.
    ARM 2: Kind: Experimental
    Label: APA
    Description: Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program.
    ARM 3: Kind: Experimental
    Label: APA+TM
    Description: Participants exercise in a gym setting 3x/week for six months, performing a combined program of adaptive physical activity (gait and balance training) and progressive treadmill walking.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary VO2 Peak baseline, 3 months, 6 months, and 3 months post-intervention Yes
Primary Berg Balance Scale baseline, 3 months, 6 months, and 3 months post-intervention Yes
Primary Dynamic Gait Index Baseline, 3 months, 6 months, and 3 months post intervention Yes
Primary Step Activity Monitoring Baseline, 3 months, 6 months, and 3 months post-intervention No
Primary 6 Minute Walks Baseline, 3 months, 6 months, and 3 months post-intervention No
Secondary Psychosocial questionnaires baseline, 3 months, 6 months, and 3 months post-intervention No

Sponsors