Activating Behavior for Lasting Engagement After Stroke

Stroke Clinical Trial

— ABLE  

Official title:

Activating Behavior for Lasting Engagement After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305731
• Other study ID #: PRO17070071
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: January 4, 2019

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Behavior, Health
• Physical Activity
• Physical Disability
• Sedentary Lifestyle
• Stroke

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Daily Number of Sedentary Breaks	Objectively measured sedentary breaks (ActivPAL)	Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Secondary	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 18 weeks
Secondary	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.	Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Secondary	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.	Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks