Activating Behavior for Lasting Engagement After Stroke
- Conditions
- Physical ActivityBehavior, HealthPhysical DisabilityStrokeSedentary Lifestyle
- Interventions
- Behavioral: Activating Behavior for Lasting Engagement
- Registration Number
- NCT03305731
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
Stroke survivors demonstrate high levels of sedentary behavior, placing them at risk for exacerbation of chronic health conditions. This may lead to recurrent stroke. Subtle cognitive impairments are common after stroke and can lead to difficulty self-monitoring and problem solving to overcome barriers to physical activity. Investigators developed the Activating Behavior for Lasting Engagement (ABLE) intervention to promote activity scheduling, self-monitoring, and problem solving activity over the full day. This study examines the effects of the ABLE intervention on sedentary behavior after stroke.
- Detailed Description
The study advisory committee added a dose-matched, no-intervention delayed baseline to the study protocol following initial documentation of this study protocol on clinicaltrials.gov. The purpose of this delayed baseline design was to assess the baseline stability on the primary and secondary outcomes. The addition of this timepoint resulted in a shift of post-intervention timepoints as follows: Baseline 1 (week 1), Baseline 2 (week 6), Post-intervention (week 11), and Follow-up (week 18). Intervention was delivered between Baseline 2 and Post-intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- diagnosis of ischemic or hemorrhagic stroke
- ≥6 months and ≤24 months post-stroke
- ≥18 years of age
- ambulatory in the community with or without an assistive device (e.g. walker, cane)
- self-reported sedentary behavior (≥6 hours/day of sedentary behavior reported using the Sedentary Behavior Questionnaire)
- reside within 50 miles of Pittsburgh, Pennsylvania
- severe aphasia (Boston Diagnostic Aphasia Examination score ≤1)
- currently receiving outpatient or home care rehabilitation services (physical therapy, occupational therapy, or speech therapy)
- current active cancer treatment
- medical history of neurodegenerative disorder (i.e. dementia, Parkinson's disease, multiple sclerosis, Lou Gehrig's disease (ALS), glioblastoma, myasthenia gravis)
- current major depressive disorder, psychiatric condition, substance abuse (Patient Health Questionnaire-9, PRIME-MD/MINI)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Activating Behavior for Lasting Engagement Activating Behavior for Lasting Engagement Participants will engage in the ABLE intervention.
- Primary Outcome Measures
Name Time Method Change in Daily Number of Sedentary Breaks Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks Objectively measured sedentary breaks (ActivPAL)
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks Objectively measured sedentary time (ActivPAL)
- Secondary Outcome Measures
Name Time Method Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks Objectively measured sedentary time (ActivPAL)
Change in Daily Number of Sedentary Breaks Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks Objectively measured sedentary breaks (ActivPAL)
Change in Participation Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States