NCT03305731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 19, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

September 29, 2017

Results QC Date

January 15, 2020

Last Update Submit

February 6, 2020

Conditions

StrokePhysical ActivitySedentary LifestyleBehavior, HealthPhysical Disability

Keywords

RehabilitationDisability

Outcome Measures

Primary Outcomes (2)

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

    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

    Objectively measured sedentary breaks (ActivPAL)

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

Secondary Outcomes (4)

  • Change in Daily Number of Sedentary Breaks

    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

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

  • Change in Participation

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

  • Change in Participation

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

Study Arms (1)

Activating Behavior for Lasting Engagement

EXPERIMENTAL

Participants will engage in the ABLE intervention.

Behavioral: Activating Behavior for Lasting Engagement

Interventions

Activating Behavior for Lasting EngagementBEHAVIORAL

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.

Activating Behavior for Lasting Engagement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

StrokeMotor ActivitySedentary BehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Results Point of Contact

Title
Dr. Emily Kringle
Organization
University of Illinois at Chicago
kringle@uic.edu
312-996-9665

Study Officials

  • Emily A Kringle, MOT, OTR/L

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Elizabeth R Skidmore, PhD, OTR/L

    University of Pittsburgh

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 10, 2017

Study Start

September 29, 2017

Primary Completion

January 4, 2019

Study Completion

January 4, 2019

Last Updated

February 19, 2020

Results First Posted

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)