teleABLE to Reduce Post-Stroke Sedentary Behavior

NCT06312709 | Active Not Recruiting

• 2 other identifiers: STUDY00021288K23HL159240
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

sedentary behavior; physical activity; behavioral activation; activity engagement; occupational therapy; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  Week 0 to Week 8

Secondary Outcomes (2)

• Between-group difference in change in sedentary behavior

  Week 0 to Week 24

• Between-group difference in change scores on health-related quality of life

  Week 0 to Week 24

Other Outcomes (4)

• Between-group difference in change in step count

  Week 0 to Week 8

• Between-group difference in change in step count

  Week 0 to Week 24

• Between-group difference in change in total activity retention

  Week 0 to Week 8

Study Arms (2)

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.

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.

Other: Health Education

Interventions

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.

Health Education

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.

teleABLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Stroke; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Emily Kringle, PhD, OTR/L

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)