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Active, Not Recruiting

NCT Number: NCT06312709

teleABLE to Reduce Post-Stroke Sedentary Behavior

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Sedentary Behavior Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)

Behavioral

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 education

Other

Health Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information.

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. 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)

  2. 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).

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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