Supervised aerobic training in Stroke and Cerebrovascular Accident - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Supervised aerobic training

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.

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Hashomer, Israel, 52621
    - Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
6 Minute Walk Test at 6 weeks
Modified Bruce Exercise Test at 6 weeks
Activity by Ankle accelerometer at 6 weeks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

Principal Investigator: David Tanne, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 2, 2005

First Submitted That Met QC Criteria