| February 2, 2007 |
| July 15, 2009 |
| October 2006 |
| December 2009 (final data collection date for primary outcome measure) |
| Ambulatory Activity Profile [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
- Self-efficacy and outcome expectations (measured
- by psychosocial questionnaires) at 6 weeks,
- 12 weeks and 24 weeks
|
| Complete list of historical versions of study NCT00431821 on ClinicalTrials.gov Archive Site |
| |
- Functional measures (ie. 30-foot timed walk and
- Step Activity Monitoring (SAM)
|
| |
| Reshaping Exercise Habits and Beliefs (REHAB) |
| Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke |
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. |
| |
| |
| Interventional |
| Other, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
- Cerebrovascular Accident
- Stroke
|
- Behavioral: Exercise
- Other: Stroke education
|
- Other: Home-based exercise prescriptions with weekly motivational telephone calls.
- Other: Stroke education program with matched attention phone calls
|
| |
| |
| Recruiting |
| 90 |
| June 2010 |
| December 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 40 Years to 85 Years |
| No |
|
|
| United States |
| |
| NCT00431821 |
| Shaughnessy, Marianne - Principal Investigator, Department of Veterans Affairs |
| H24242 |
| Department of Veterans Affairs |
|
| Principal Investigator: |
Marianne Shaughnessy, RN PhD |
VA Maryland Health Care System, Baltimore |
|
|
| Department of Veterans Affairs |
| July 2009 |