Activating Behavior for Lasting Engagement After Stroke (ABLE)

February 6, 2020 updated by: Emily Kringle, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activating Behavior for Lasting Engagement
Participants will engage in the ABLE intervention.
Behavioral: Activating Behavior for Lasting Engagement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
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)
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
Time Frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
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
Time Frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Objectively measured sedentary time (ActivPAL)
Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Emily A Kringle, MOT, OTR/L, University of Pittsburgh
  • Study Chair: Elizabeth R Skidmore, PhD, OTR/L, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Actual)

January 4, 2019

Study Completion (Actual)

January 4, 2019

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO17070071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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