Reshaping Exercise Habits and Beliefs (REHAB)

Stroke Clinical Trial

— REHAB  

Official title:

Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431821
• Other study ID #: H24242
• Status: Completed
• Phase: N/A
• First received: February 2, 2007
• Last updated: July 18, 2013
• Start date: October 2006
• Est. completion date: October 2012

Study information

• Verified date: July 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. This study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 40-85 years old ischemic Stroke patients,

2. Stroke onset <90 days at enrollment,

3. Hemiparetic gait disorder,

4. Patients able to walk 30ft with or w/out assistive device,

5. Sufficient English comprehension to understand instructions, provide consent, and answer questions,

6. Lives within 30 miles of the Greater Baltimore area.

Exclusion Criteria:

1. Dementia (extended MMSE <85 or <80 if education level below 9th grade),

2. Untreated major clinical depression (CES-D>16) and confirmed with clinical interview,

3. Heavy alcohol use (<3 oz liquor, 3, 4-oz glasses of wine, or 3, 12- oz beers daily),

4. Active cancer, or any illness with a life expectancy of less than 6 months,

5. Any condition in which exercise activity would be contraindicated including, but not limited to: unstable angina, cardiac ischemic event within the past 6 months, congestive heart failure (Stage III or IV), major orthopedic chronic pain or non-stroke neuromuscular disorders restricting exercise, oxygen-dependent COPD or peripheral neuropathy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Exercise
Home-based exercise prescriptions with weekly motivational telephone calls.

Other:
• Stroke education
Stroke education program with matched attention phone calls

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Activity Profile		6 months	No