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Early Aerobic Training Program After Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00248222
First received: November 2, 2005
Last updated: October 26, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Stroke
Cerebrovascular Accident
 Behavioral: Supervised aerobic training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 6 Minute Walk Test at 6 weeks
  • Modified Bruce Exercise Test at 6 weeks
  • Activity by Ankle accelerometer at 6 weeks

Secondary Outcome Measures:
  • 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

Study Start Date: October 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • minor ischemic stroke

Exclusion Criteria:

  • unstable angina
  • severe lung disease
  • severe symptomatic peripheral vascular disease
  • dementia or other severe neurological disease
  • other severe uncontrolled medical problem
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248222

Locations
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: David Tanne, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Prof. David Tanne, Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00248222     History of Changes
Other Study ID Numbers: SHEBA-05-3840-DT-CTIL
Study First Received: November 2, 2005
Last Updated: October 26, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Exercise
Rehabilitation
Aerobic training

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013