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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014