Early Aerobic Training Program After Ischemic Stroke | NCT00248222

Studies
Early Aerobic Training Program After Ischemic Stroke

NCT00248222

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Oct 27, 2009Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Stroke
Cerebrovascular Accident

Interventions

Supervised aerobic training

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Nov 2, 2005

First Submission Date that Met QC Criteria

Nov 2, 2005

First Posted Date

Nov 3, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2009

Last Update Posted Date

Oct 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Supervised aerobic training	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6 Minute Walk Test at 6 weeks
Modified Bruce Exercise Test at 6 weeks
Activity by Ankle accelerometer at 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Recurrent vascular events at 6 weeks
METS at 6 weeks
Stair climbing ascend and descend test at 6 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Tanne, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaim Sheba Medical Center		Tel Litwinsky		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D009043	Motor Activity

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided