StroketeleABLENCT05029284
Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth
A study testing teleABLE in people with Stroke and Stroke, Ischemic, run by University of Minnesota at 1 site in United States.
Trial summary
Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- teleABLE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 18 Mar 2024
- 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
- Stroke diagnosis ≤12 months prior to study enrollment
- ≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire)
- Ambulatory 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 the participant has 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 (assessed by 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 11Show fewer
- Diagnosis of a terminal illness and/or in hospice care
- 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 another rehabilitation intervention research study
- Investigator discretion for safety or adherence reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
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 (Formative Phase)
Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time.
The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention.
Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- teleABLE
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teleABLEBehavioural
Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.
| Study group | Role | What they receive |
|---|---|---|
| teleABLE | Experimental | Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. Receives: Behavioral: teleABLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported.
Measured: week 2 through week 7
Participant Satisfaction
Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction.
Measured: week 8
Secondary outcomes (3)
Change in Participation Restrictions
Assessed by the Activity Card Sort 3. This is a 100-item tool during which participants indicate whether they did the activity prior to their stroke, continue to do the activity since their stroke, or have given up the activity since their stroke. Change in the proportion of activities retained will be reported.
Measured: week 0 to week 8
Change in Health-Related Quality of Life
Assessed by the EuroQol-5 Dimension-5 Level. This is a 5-item self-report questionnaire with each item scored on a 1 to 5 scale. Scores are converted to Index Scores following published procedures (possible range -1 to 1), with high scores indicating high quality of life.
Measured: week 0 to week 8
Change in Sedentary Minutes
Assessed using the activPAL micro3 monitor following a 7-day wear protocol. The mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be computed for each time point. Change in mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be reported.
Measured: week 0 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start20 Dec 2021
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
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.
- 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
- 11 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
- NCT05029284
- Sponsor's protocol ID
- 2021-0059
- Other IDs
- K23HL159240
- Acronym
- teleABLE
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2021
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. 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 (Formative Phase)
- ClinicalTrials.gov ID
- NCT05029284
- Acronym / sponsor ID
- teleABLE / 2021-0059
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time.
The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention.
Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teleABLE | Experimental | Behavioral: teleABLEParticipants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke diagnosis ≤12 months prior to study enrollment
- ≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire)
- Ambulatory 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 the participant has face-to-face interaction at least one time per week
Key exclusion criteria (11 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 (assessed by 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 |
|---|---|---|
| teleABLEParticipants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions. | Behavioural | teleABLE |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: week 2 through week 7
The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported.
Participant Satisfaction
Time frame: week 8
Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction.
3 secondary outcomes
Change in Participation Restrictions
Time frame: week 0 to week 8
Change in Health-Related Quality of Life
Time frame: week 0 to week 8
Change in Sedentary Minutes
Time frame: week 0 to week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 in people with Stroke and Stroke, Ischemic, 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 6 inclusion and 11 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 29 Jun 2025. 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 29 Jun 2025). 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?
Incidence of Treatment-Emergent Adverse Events (time frame: week 2 through week 7). 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 29 Jun 2025.