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Activating Behavior for Lasting Engagement After Stroke (ABLE)

Primary Purpose

Stroke, Physical Activity, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activating Behavior for Lasting Engagement
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Disability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Activating Behavior for Lasting Engagement

Arm Description

Participants will engage in the ABLE intervention.

Outcomes

Primary Outcome Measures

Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Objectively measured sedentary time (ActivPAL)
Change in Daily Number of Sedentary Breaks
Objectively measured sedentary breaks (ActivPAL)

Secondary Outcome Measures

Change in Daily Number of Sedentary Breaks
Objectively measured sedentary breaks (ActivPAL)
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Objectively measured sedentary time (ActivPAL)
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.
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.

Full Information

First Posted
September 29, 2017
Last Updated
February 6, 2020
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03305731
Brief Title
Activating Behavior for Lasting Engagement After Stroke
Acronym
ABLE
Official Title
Activating Behavior for Lasting Engagement After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
January 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physical Activity, Sedentary Lifestyle, Behavior, Health, Physical Disability
Keywords
Rehabilitation, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activating Behavior for Lasting Engagement
Arm Type
Experimental
Arm Description
Participants will engage in the ABLE intervention.
Intervention Type
Behavioral
Intervention Name(s)
Activating Behavior for Lasting Engagement
Intervention Description
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 Outcome Measure Information:
Title
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Description
Objectively measured sedentary time (ActivPAL)
Time Frame
Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Title
Change in Daily Number of Sedentary Breaks
Description
Objectively measured sedentary breaks (ActivPAL)
Time Frame
Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Secondary Outcome Measure Information:
Title
Change in Daily Number of Sedentary Breaks
Description
Objectively measured sedentary breaks (ActivPAL)
Time Frame
Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Title
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Description
Objectively measured sedentary time (ActivPAL)
Time Frame
Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Title
Change in Participation
Description
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
Title
Change in Participation
Description
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 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily A Kringle, MOT, OTR/L
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth R Skidmore, PhD, OTR/L
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Activating Behavior for Lasting Engagement After Stroke

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