Reshaping Exercise Habits and Beliefs (REHAB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00431821
First received: February 2, 2007
Last updated: July 18, 2013
Last verified: July 2013
  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 and 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke

Resource links provided by NLM:


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
Study Completion Date: October 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Home-based exercise prescriptions with weekly motivational telephone calls.
Behavioral: Exercise
Home-based exercise prescriptions with weekly motivational telephone calls.
Arm 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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Marianne Shaughnessy, RN PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00431821     History of Changes
Other Study ID Numbers: H24242
Study First Received: February 2, 2007
Last Updated: July 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
Rehabilitation
Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014