NCT00248222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2005

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

3.7 years

First QC Date

November 2, 2005

Last Update Submit

October 26, 2009

Conditions

StrokeCerebrovascular Accident

Keywords

ExerciseRehabilitationAerobic training

Outcome Measures

Primary Outcomes (3)

  • 6 Minute Walk Test at 6 weeks

  • Modified Bruce Exercise Test at 6 weeks

  • Activity by Ankle accelerometer at 6 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

Supervised aerobic trainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minor ischemic stroke

You may not qualify if:

  • unstable angina
  • severe lung disease
  • severe symptomatic peripheral vascular disease
  • dementia or other severe neurological disease
  • other severe uncontrolled medical problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • David Tanne, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 3, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

IL(1)