Reshaping Exercise Habits and Beliefs (REHAB)

This study is currently recruiting participants.

Verified by Department of Veterans Affairs, July 2009

First Received: February 2, 2007 Last Updated: July 15, 2009 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00431821

Purpose

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 an encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.

Condition	Intervention
Cerebrovascular Accident Stroke	Behavioral: Exercise Other: Stroke education

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Ambulatory Activity Profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Home-based exercise prescriptions with weekly motivational telephone calls.	Behavioral: Exercise Home-based exercise prescriptions with weekly motivational telephone calls.
2 Stroke education program with matched attention phone calls	Other: Stroke education Stroke education program with matched attention phone calls

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

40-85 years old ischemic Stroke patients,
Stroke onset <90 days at enrollment,
Hemiparetic gait disorder,
Patients able to walk 30ft with or w/out assistive device,
Sufficient English comprehension to understand instructions, provide consent, and answer questions,
Lives within 30 miles of the Greater Baltimore area.

Exclusion Criteria:

Dementia (extended MMSE <85 or <80 if education level below 9th grade),
Untreated major clinical depression (CES-D>16) and confirmed with clinical interview,
Heavy alcohol use (<3 oz liquor, 3, 4-oz glasses of wine, or 3, 12- oz beers daily),
Active cancer, or any illness with a life expectancy of less than 6 months,
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431821

Contacts

Contact: Alyssa D Stookey, PhD MS

(410) 605-7000 ext 5431

alyssa.mealey@va.gov

Locations

United States, Maryland
VA Maryland Health Care System, Baltimore	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Marianne Shaughnessy, RN PhD mshaughn@grecc.umaryland.edu
Contact: Richard Macko (410) 605-7000 ext 5413 rmacko@grecc.umary.edu
Principal Investigator: Marianne Shaughnessy, RN PhD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Marianne Shaughnessy, RN PhD

VA Maryland Health Care System, Baltimore

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Shaughnessy, Marianne - Principal Investigator )
Study ID Numbers:	H24242
Study First Received:	February 2, 2007
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00431821 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Exercise
Rehabilitation
Stroke

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 27, 2009