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Early Aerobic Training Program After Ischemic Stroke

Primary Purpose

Stroke, Cerebrovascular Accident

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Supervised aerobic training
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Exercise, Rehabilitation, Aerobic training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chaim Sheba Medical Center

Outcomes

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

Full Information

First Posted
November 2, 2005
Last Updated
October 26, 2009
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00248222
Brief Title
Early Aerobic Training Program After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident
Keywords
Exercise, Rehabilitation, Aerobic training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Supervised aerobic training
Primary Outcome Measure Information:
Title
6 Minute Walk Test at 6 weeks
Title
Modified Bruce Exercise Test at 6 weeks
Title
Activity by Ankle accelerometer at 6 weeks
Secondary Outcome Measure Information:
Title
Recurrent vascular events at 6 weeks
Title
METS at 6 weeks
Title
Stair climbing ascend and descend test at 6 weeks
Title
Four Square Step Test at 6 weeks
Title
Gait symmetry by SmartStep at 6 weeks
Title
Walking Impairment Questionnaire at 6 weeks
Title
Rivermead Mobility Index at 6 weeks
Title
Similar outcome measures 3 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tanne, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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Early Aerobic Training Program After Ischemic Stroke

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