An interventional study of Activating Behavior for Lasting Engagement in Stroke, Physical Activity and Sedentary Lifestyle, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 21 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Objectively measured sedentary time (ActivPAL)
Time frame: 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)
Time frame: 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)
Time frame: 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
Objectively measured sedentary time (ActivPAL)
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
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.
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
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.
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
| Milestone | Activating Behavior for Lasting Engagement |
|---|---|
| Started | 21 |
| Week 6 | 20 |
| Week 11 | 20 |
| Completed | 20 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
Objectively measured sedentary time (ActivPAL)
| minutes | Activating Behavior for Lasting Engagement |
|---|---|
| Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | 54.95 ± 81.10 |
Objectively measured sedentary breaks (ActivPAL)
| breaks | Activating Behavior for Lasting Engagement |
|---|---|
| Change in Daily Number of Sedentary Breaks | 2.61 ± 4.59 |
Objectively measured sedentary breaks (ActivPAL)
| breaks | Activating Behavior for Lasting Engagement |
|---|---|
| Change in Daily Number of Sedentary Breaks | -2.55 ± 5.90 |
Objectively measured sedentary time (ActivPAL)
| minutes | Activating Behavior for Lasting Engagement |
|---|---|
| Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | 14.08 ± 58.95 |
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.
| score on a scale | Activating Behavior for Lasting Engagement |
|---|---|
| Change in Participation | 1.48 ± 8.52 |
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.
| score on a scale | Activating Behavior for Lasting Engagement |
|---|---|
| Change in Participation | 1.33 ± 15.38 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Activating Behavior for Lasting Engagement |
|---|---|
| Mean | 70.81 ± 10.92 |
| Sex: Female, Male(Participants) | Activating Behavior for Lasting Engagement |
|---|---|
| Female | 13 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Activating Behavior for Lasting Engagement |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Activating Behavior for Lasting Engagement |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Activating Behavior for Lasting Engagement |
|---|---|
| United States | 21 |
| Stroke Chronicity(months) | Activating Behavior for Lasting Engagement |
|---|---|
| Mean | 29.38 ± 14.34 |
| Stroke Type(Participants) | Activating Behavior for Lasting Engagement |
|---|---|
| Ischemic | 19 |
| Hemorrhagic | 2 |
| Stroke Hemisphere(Participants) | Activating Behavior for Lasting Engagement |
|---|---|
| Left Hemisphere | 12 |
| Right Hemisphere | 7 |
| Both Hemispheres | 2 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Jan 2019, 15 months.
Results were first posted in Feb 2020, 1 year 1 month after primary completion.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 15 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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