StrokeNCT06312709
teleABLE to Reduce Post-Stroke Sedentary Behavior
A study testing teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) and Health Education in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age: 18 years or older
- Diagnosis: Stroke diagnosis ≤12 months prior to study enrollment
- ≥6 hours of sedentary behavior on a typical weekday (Sedentary Behavior Questionnaire)
- Able to walk 150 feet or more without physical assistance from another person, with or without assistive device (assessed by Functional Independence Measure, mobility score ≥5)
- Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application
- Able to identify a support person with whom they have a face-to-face interaction at least one time per week.
- Able and willing to participate fully in the study and provide informed consent
Who cannot join
- Currently receiving care in an inpatient rehabilitation, transitional care unit, or skilled nursing facility
- Severe cognitive or communication impairments (inability to respond accurately to complete study telephone screening or complete informed consent)
- Comorbid neurodegenerative disorder (e.g. Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma)
- Comorbid cancer, currently undergoing chemotherapy or radiation treatment
- Comorbid major depressive disorder (Patient Health Questionnaire-2, score ≥2)
- Received inpatient treatment or hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
Show all 12Show fewer
- Diagnosis of a terminal illness and/or currently receiving hospice care
- Currently pregnant or expecting to become pregnant in the next 6 months
- History of skin sensitivity that precludes the use of medical tape necessary for adherence to activity monitor measure
- Inability to speak, read, or understand English
- Concurrent participation in any other rehabilitation intervention research study (including cognitive and/or physical rehabilitation studies)
- Investigator discretion for safety or adherence reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Kinesiology, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)
The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.
Participants in this study will:
- Complete questionnaires at Weeks 1, 8, and 24
- Wear an activPAL monitor at Weeks 1, 8, and 24
- Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions)
- Complete an interview at Week 24
- Conditions
- Stroke
- Being tested
- teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement), Health Education
- Keywords
- sedentary behavior, physical activity, behavioral activation, activity engagement, occupational therapy, rehabilitation
- Medical subject headings
- Stroke, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)Behavioural
teleABLE uses behavioral activation to build personally meaningful non-sedentary throughout the day. This is accomplished using a global strategy, the ICAN Planning Process, which guides participants through activity scheduling, activity monitoring, self-assessment, and collaborative problem solving.
Health EducationOther
Health Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information.
| Study group | Role | What they receive |
|---|---|---|
| teleABLE | Experimental | Participants meet with a study therapist 2x/week for 6 weeks (12 sessions) to complete behavioral activation focused on adding personally meaningful non-sedentary activities during times when they typically spend sitting. All sessions are delivered remotely using Zoom videoconferencing. Receives: Behavioral: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) |
| Health Education | Active comparator | Participants meet with a study therapist 1x/week for 6 weeks (6 sessions) to review fact sheets focused on healthy lifestyles after stroke. All sessions are delivered remotely using Zoom videoconferencing. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in change scores on health-related quality of life
European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best).
Measured: Week 0 to Week 8
Between-group difference in change in sedentary behavior
Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol)
Measured: Week 0 to Week 8
Secondary outcomes (2)
Between-group difference in change in sedentary behavior
Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol)
Measured: Week 0 to Week 24
Between-group difference in change scores on health-related quality of life
European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best).
Measured: Week 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start4 Apr 2024
- Primary completion28 Apr 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Emily Kringle, PhD, OTR/L, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312709
- Sponsor's protocol ID
- STUDY00021288
- Other IDs
- K23HL159240
- Status last verified
- Sep 2026
- First submitted
- 8 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06312709
- Acronym / sponsor ID
- STUDY00021288
- Conditions
- Stroke
- Keywords
- sedentary behavior, physical activity, behavioral activation, activity engagement, occupational therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.
Participants in this study will:
- Complete questionnaires at Weeks 1, 8, and 24
- Wear an activPAL monitor at Weeks 1, 8, and 24
- Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions)
- Complete an interview at Week 24
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| teleABLE | Experimental | Behavioral: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)Participants meet with a study therapist 2x/week for 6 weeks (12 sessions) to complete behavioral activation focused on adding personally meaningful non-sedentary activities during times when they typically spend sitting. All sessions are delivered remotely using Zoom videoconferencing. |
| Health Education | Active comparator | Other: Health EducationParticipants meet with a study therapist 1x/week for 6 weeks (6 sessions) to review fact sheets focused on healthy lifestyles after stroke. All sessions are delivered remotely using Zoom videoconferencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 years or older
- Diagnosis: Stroke diagnosis ≤12 months prior to study enrollment
- ≥6 hours of sedentary behavior on a typical weekday (Sedentary Behavior Questionnaire)
- Able to walk 150 feet or more without physical assistance from another person, with or without assistive device (assessed by Functional Independence Measure, mobility score ≥5)
- Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application
Key exclusion criteria (12 listed)
- Currently receiving care in an inpatient rehabilitation, transitional care unit, or skilled nursing facility
- Severe cognitive or communication impairments (inability to respond accurately to complete study telephone screening or complete informed consent)
- Comorbid neurodegenerative disorder (e.g. Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma)
- Comorbid cancer, currently undergoing chemotherapy or radiation treatment
- Comorbid major depressive disorder (Patient Health Questionnaire-2, score ≥2)
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 |
|---|---|---|
| teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)teleABLE uses behavioral activation to build personally meaningful non-sedentary throughout the day. This is accomplished using a global strategy, the ICAN Planning Process, which guides participants through activity scheduling, activity monitoring, self-assessment, and collaborative problem solving. | Behavioural | teleABLE |
| Health EducationHealth Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information. | Other | Health Education |
Primary outcome
Between-group difference in change scores on health-related quality of life
Time frame: Week 0 to Week 8
European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best).
Between-group difference in change in sedentary behavior
Time frame: Week 0 to Week 8
Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol)
2 secondary outcomes
Between-group difference in change in sedentary behavior
Time frame: Week 0 to Week 24
Between-group difference in change scores on health-related quality of life
Time frame: Week 0 to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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 Kringle, PhD, OTR/L principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) and Health Education in people with Stroke, run by University of Minnesota 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 7 inclusion and 12 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 10 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Between-group difference in change scores on health-related quality of life (time frame: Week 0 to Week 8). 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 10 Sep 2026.