Reshaping Exercise Habits and Beliefs (REHAB)
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00431821
First received: February 2, 2007
Last updated: June 27, 2012
Last verified: June 2012
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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 |
| Estimated 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:
- 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
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: | June 27, 2012 |
| 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 May 16, 2013