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Completed

NCT Number: NCT03305731

Activating Behavior for Lasting Engagement After Stroke

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.

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Key information

Conditions

Stroke Behavior Behavior, Health Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Motor Activity Nervous System Diseases Physical Activity Physical Disability Sedentary Behavior Sedentary Lifestyle Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Activating Behavior for Lasting Engagement

Behavioral

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.

Primary outcomes

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

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

    Objectively measured sedentary time (ActivPAL)

  2. Change in Daily Number of Sedentary Breaks

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

    Objectively measured sedentary breaks (ActivPAL)

Secondary outcomes

  1. Change in Daily Number of Sedentary Breaks

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

    Objectively measured sedentary breaks (ActivPAL)

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

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

    Objectively measured sedentary time (ActivPAL)

  3. Change in Participation

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

  4. Change in Participation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: ABLE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2017
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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