Reshaping Exercise Habits and Beliefs (REHAB)

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00431821
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 72
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident; Stroke	Behavioral: Exercise; Other: Stroke education	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1 Home-based exercise prescriptions with weekly motivational telephone calls.	Behavioral: Exercise; Home-based exercise prescriptions with weekly motivational telephone calls.
Other: Arm 2 Stroke education program with matched attention phone calls	Other: Stroke education; Stroke education program with matched attention phone calls

Outcome Measures

Primary Outcome Measures

1. Ambulatory Activity Profile [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Marianne Shaughnessy, RN PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00431821
• Other Study ID Numbers: H24242
• First Posted: Feb 6, 2007
• Last Update Posted: Jul 22, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by US Department of Veterans Affairs: Exercise; Rehabilitation; Stroke
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Jul 22, 2013