Early Aerobic Training Program After Ischemic Stroke - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00248222

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 II

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Study ID Numbers:	SHEBA-05-3840-DT-CTIL
Study First Received:	November 2, 2005
Last Updated:	July 1, 2007
ClinicalTrials.gov Identifier:	NCT00248222 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Exercise
Rehabilitation
Aerobic training

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009