Clinical trial NCT03305731: Activating Behavior for Lasting Engagement After Stroke
Official title: Activating Behavior for Lasting Engagement After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Physical Activity
Sedentary Lifestyle
Behavior, Health
Physical Disability
Keywords: Rehabilitation
Disability
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
timeFrame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
measure: Change in Daily Number of Sedentary Breaks
timeFrame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Secondary outcomes:
measure: Change in Daily Number of Sedentary Breaks
timeFrame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
measure: Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
timeFrame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
measure: Change in Participation
timeFrame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
measure: Change in Participation
timeFrame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Emily A Kringle, MOT, OTR/L
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Elizabeth R Skidmore, PhD, OTR/L
role: STUDY_CHAIR
References: