Behavior, Health, Physical Activity, Physical Disability, Sedentary Lifestyle, Stroke
Conditions
Keywords
Rehabilitation, Disability
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.
Interventions
BEHAVIORALActivating 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.
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 11 weeks | Objectively measured sedentary time (ActivPAL) |
| Change in Daily Number of Sedentary Breaks | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks | Objectively measured sedentary breaks (ActivPAL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Number of Sedentary Breaks | Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks | Objectively measured sedentary breaks (ActivPAL) |
| 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 | Objectively measured sedentary time (ActivPAL) |
| Change in Participation | Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Activating Behavior for Lasting Engagement |
|---|---|
| Age, Continuous | 70.81 years STANDARD_DEVIATION 10.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Prolonged Sitting | 466.56 minutes STANDARD_DEVIATION 168.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 8 Participants |
| Stroke Chronicity | 29.38 months STANDARD_DEVIATION 14.34 |
| Stroke Hemisphere Both Hemispheres | 2 Participants |
| Stroke Hemisphere Left Hemisphere | 12 Participants |
| Stroke Hemisphere Right Hemisphere | 7 Participants |
| Stroke Type Hemorrhagic | 2 Participants |
| Stroke Type Ischemic | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Change in Daily Number of Sedentary Breaks | 2.61 breaks | Standard Deviation 4.59 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | 54.95 minutes | Standard Deviation 81.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Change in Daily Number of Sedentary Breaks | -2.55 breaks | Standard Deviation 5.9 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes | 14.08 minutes | Standard Deviation 58.95 |
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.
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Change in Participation | 1.48 score on a scale | Standard Deviation 8.52 |
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.
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activating Behavior for Lasting Engagement | Change in Participation | 1.33 score on a scale | Standard Deviation 15.38 |