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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Experimental | Participants will engage in the ABLE intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activating Behavior for Lasting Engagement | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily A Kringle, MOT, OTR/L | University of Pittsburgh | Principal Investigator |
| Elizabeth R Skidmore, PhD, OTR/L | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Activating Behavior for Lasting Engagement | Participants will engage in the ABLE intervention. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Activating Behavior for Lasting Engagement | Participants will engage in the ABLE intervention. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | Objectively measured sedentary time (ActivPAL) | Posted | Mean | Standard Deviation | minutes | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Activating Behavior for Lasting Engagement | Participants will engage in the ABLE intervention. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Kringle | University of Illinois at Chicago | 312-996-9665 | kringle@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 29, 2018 | Feb 6, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Objectively measured sedentary time (ActivPAL)
| 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. | 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. | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Stroke Chronicity | Months elapsed between date of stroke onset and date of baseline testing. Date of stroke onset was extracted from medical records. | Mean | Standard Deviation | months |
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| Stroke Type | Count of Participants | Participants |
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| Stroke Hemisphere | Count of Participants | Participants |
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| Prolonged Sitting | Measured using ActivPAL micro3 (Pal Technologies, Glasgow) following 7-day wear protocol. The mean daily duration of prolonged sitting accumulated in bouts of greater than or equal to 30 minutes was computed. | Non-compliance with activity monitor, n=1 | Mean | Standard Deviation | minutes |
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| Participants |
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| Primary | Change in Daily Number of Sedentary Breaks | Objectively measured sedentary breaks (ActivPAL) | Posted | Mean | Standard Deviation | breaks | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks |
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| Secondary | Change in Daily Number of Sedentary Breaks | Objectively measured sedentary breaks (ActivPAL) | Posted | Mean | Standard Deviation | breaks | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks |
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| Secondary | Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | Objectively measured sedentary time (ActivPAL) | Posted | Mean | Standard Deviation | minutes | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks |
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| 21 |
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| 21 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |