MedPath

Activating Behavior for Lasting Engagement After Stroke

Not Applicable
Completed
Conditions
Physical Activity
Behavior, Health
Physical Disability
Stroke
Sedentary 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
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Activating Behavior for Lasting EngagementActivating Behavior for Lasting EngagementParticipants will engage in the ABLE intervention.
Primary Outcome Measures
NameTimeMethod
Change in Daily Number of Sedentary BreaksBaseline (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 MinutesBaseline (Baseline=computed mean of week 1 and week 6) to 11 weeks

Objectively measured sedentary time (ActivPAL)

Secondary Outcome Measures
NameTimeMethod
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 MinutesBaseline (Baseline=computed mean of week 1 and week 6) to 18 weeks

Objectively measured sedentary time (ActivPAL)

Change in Daily Number of Sedentary BreaksBaseline (Baseline=computed mean of week 1 and week 6) to 18 weeks

Objectively measured sedentary breaks (ActivPAL)

Change in ParticipationBaseline (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

© Copyright 2025. All Rights Reserved by MedPath