StrokeABLENCT03305731
Activating Behavior for Lasting Engagement After Stroke
A study testing Activating Behavior for Lasting Engagement in people with Stroke and Physical Activity, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Physical Activity, Sedentary Lifestyle
- What is being tested?
- Activating Behavior for Lasting Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 4 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
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.
Read the 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.
- Being tested
- Activating Behavior for Lasting Engagement
- Keywords
- Rehabilitation, Disability
- Medical subject headings
- Stroke, Motor Activity, Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activating Behavior for Lasting EngagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Activating Behavior for Lasting Engagement | Experimental | Participants will engage in the ABLE intervention. Receives: Behavioral: Activating Behavior for Lasting Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Objectively measured sedentary time (ActivPAL)
Measured: 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)
Measured: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Secondary outcomes (4)
Change in Daily Number of Sedentary Breaks
Objectively measured sedentary breaks (ActivPAL)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start29 Sep 2017
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Kringle, University of Pittsburgh
- Investigators
- Emily A Kringle, MOT, OTR/L, Principal investigator, University of PittsburghElizabeth R Skidmore, PhD, OTR/L, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305731
- Sponsor's protocol ID
- PRO17070071
- Acronym
- ABLE
- Status last verified
- Feb 2020
- First submitted
- 29 Sep 2017
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Behavior for Lasting Engagement After Stroke
- ClinicalTrials.gov ID
- NCT03305731
- Acronym / sponsor ID
- ABLE / PRO17070071
- Keywords
- Rehabilitation, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Posted 19 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activating Behavior for Lasting Engagement | Experimental | Behavioral: Activating Behavior for Lasting EngagementParticipants will engage in the ABLE intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activating Behavior for Lasting EngagementActivating 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. | Behavioural | Activating Behavior for Lasting Engagement |
Primary outcome
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
Time frame: 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
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Objectively measured sedentary breaks (ActivPAL)
4 secondary outcomes
Change in Daily Number of Sedentary Breaks
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
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Change in Participation
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Change in Participation
Time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily A Kringle, MOT, OTR/L principal investigator
University of Pittsburgh
Elizabeth R Skidmore, PhD, OTR/L study chair
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activating Behavior for Lasting Engagement in people with Stroke and Physical Activity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes (time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.