Early Aerobic Training Program After Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke.

Detailed Description

The purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke. Patients after a minor ischemic stroke would be randomized within 1-3 weeks of stroke onset to a control group (6 weeks of low intensity stretching and coordination exercises followed by a supervised aerobic training program) or an experimental group (immediate aerobic training program). Patients will be evaluated for measures of ambulation endurance, mobility, gait, functional assessment and clinical follow-up after 6 weeks and again 3 months later.

Conditions

Interventions

Trial Design

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

Patient Involvement

Patients after a minor ischemic stroke would be randomized within 1-3 weeks of stroke onset to a control group (6 weeks of low intensity stretching and coordination exercises followed by a supervised aerobic training program) or an experimental group (immediate aerobic training program). Patients will be evaluated for measures of ambulation endurance, mobility, gait, functional assessment and clinical follow-up after 6 weeks and again 3 months later.

Outcomes

Type Measure Time Frame Safety Issue
Primary 6 Minute Walk Test at 6 weeks; Modified Bruce Exercise Test at 6 weeks; Activity by Ankle accelerometer at 6 weeks.
Secondary Recurrent vascular events at 6 weeks; METS at 6 weeks; stair climbing ascend and descend test at 6 weeks; Four Square Step Test at 6 weeks; Gait Symmetry by SmartStep at 6 weeks; Walking Impairment Questionnaire at 6 weeks; Rivermead Mobility Index at 6 weeks; Similar outcome measures 3 months later.
Primary 6 Minute Walk Test at 6 weeks
Primary Modified Bruce Exercise Test at 6 weeks
Primary Activity by Ankle accelerometer at 6 weeks
Secondary Recurrent vascular events at 6 weeks
Secondary METS at 6 weeks
Secondary Stair climbing ascend and descend test at 6 weeks
Secondary Four Square Step Test at 6 weeks
Secondary Gait symmetry by SmartStep at 6 weeks
Secondary Walking Impairment Questionnaire at 6 weeks
Secondary Rivermead Mobility Index at 6 weeks
Secondary Similar outcome measures 3 months later

Sponsors