teleABLE to Reduce Post-Stroke Sedentary Behavior

April 30, 2026 updated by: University of Minnesota

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Karli Jahnke, MOT, OTR/L
  • Phone Number: 612-626-4046
  • Email: dwell@umn.edu

Study Contact Backup

  • Name: Emily Kringle, PhD, OTR/L
  • Phone Number: 612-626-4046
  • Email: dwell@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • School of Kinesiology, University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: teleABLE
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.
Behavioral: 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.
Active Comparator: Health Education
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.
Other: Health Education
Health Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Week 0 to Week 8
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)
Week 0 to Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between-group difference in change in sedentary behavior
Time Frame: Week 0 to Week 24
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)
Week 0 to Week 24
Between-group difference in change scores on health-related quality of life
Time Frame: Week 0 to Week 24
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).
Week 0 to Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between-group difference in change in step count
Time Frame: Week 0 to Week 8
Mean daily step count measured using the activPAL micro4 (7-day wear protocol)
Week 0 to Week 8
Between-group difference in change in step count
Time Frame: Week 0 to Week 24
Mean daily step count measured using the activPAL micro4 (7-day wear protocol)
Week 0 to Week 24
Between-group difference in change in total activity retention
Time Frame: Week 0 to Week 8
Change in the proportion of total activities retained measured using the Activity Card Sort (ACS3)
Week 0 to Week 8
Between-group difference in change in total activity retention
Time Frame: Week 0 to Week 24
Change in the proportion of total activities retained measured using the Activity Card Sort (ACS3)
Week 0 to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily Kringle, PhD, OTR/L, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00021288
  • K23HL159240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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