Activating Behavior for Lasting Engagement After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Activating Behavior for Lasting Engagement After Stroke

Conditions
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Stroke, Physical Activity, Sedentary Lifestyle, Behavior, Health, Physical Disability

Intervention / Treatment
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* Behavioral: Activating Behavior for Lasting Engagement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activating Behavior for Lasting Engagement<br>Participants will engage in the ABLE intervention. | Behavioral: Activating Behavior for Lasting Engagement<br>* Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | Objectively measured sedentary time (ActivPAL) | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks | 
| Change in Daily Number of Sedentary Breaks | Objectively measured sedentary breaks (ActivPAL) | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Number of Sedentary Breaks | Objectively measured sedentary breaks (ActivPAL) | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks | 
| Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | Objectively measured sedentary time (ActivPAL) | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks | 
| Change in Participation | 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. | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks | 
| Change in Participation | 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. | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Disability