Early Aerobic Training Program After Ischemic Stroke

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248222
• Other study ID #: SHEBA-05-3840-DT-CTIL
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2005
• Last updated: October 26, 2009
• Start date: October 2005
• Est. completion date: June 2009

Study information

• Verified date: October 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Supervised aerobic training

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test at 6 weeks
Primary	Modified Bruce Exercise Test at 6 weeks
Primary	Activity by Ankle accelerometer at 6 weeks
Secondary	Recurrent vascular events at 6 weeks
Secondary	METS at 6 weeks
Secondary	Stair climbing ascend and descend test at 6 weeks
Secondary	Four Square Step Test at 6 weeks
Secondary	Gait symmetry by SmartStep at 6 weeks
Secondary	Walking Impairment Questionnaire at 6 weeks
Secondary	Rivermead Mobility Index at 6 weeks
Secondary	Similar outcome measures 3 months later