Activating Behavior for Lasting Engagement After Stroke

University of Pittsburgh21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Physical Activity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. diagnosis of ischemic or hemorrhagic stroke 2. ≥6 months and ≤24 months post-stroke 3. ≥18 years of age 4. ambulatory in the community with or without an assistive device (e.g. walker, cane) 5. self-reported sedentary behavior (≥6 hours/day of sedentary behavior reported using the Sedentary Behavior Questionnaire) 6. reside within 50 miles of Pittsburgh, Pennsylvania Exclusion Criteria: 1. severe aphasia (Boston Diagnostic Aphasia Examination score ≤1) 2. currently receiving outpatient or home care rehabilitation services (physical therapy, occupational therapy, or speech therapy) 3. current active cancer treatment 4. medical history of neurodegenerative disorder (i.e. dementia, Parkinson's disease, multiple sclerosis, Lou Gehrig's disease (ALS), glioblastoma, myasthenia gravis) 5. current major depressive disorder, psychiatric condition, substance abuse (Patient Health Questionnaire-9, PRIME-MD/MINI)

Outcomes

Primary Outcomes

Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes

Objectively measured sedentary time (ActivPAL)

Time frame: 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)

Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks

Secondary Outcomes

Change in Daily Number of Sedentary Breaks

Objectively measured sedentary breaks (ActivPAL)

Time frame: 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)

Time frame: 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.

Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks

Change in Participation

Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks

Activating Behavior for Lasting Engagement After Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes