Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth

NCT ID: NCT05029284

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2024-03-18

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

teleABLE

Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook.

Group Type: EXPERIMENTAL

teleABLE

Intervention Type: BEHAVIORAL

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.

Interventions

teleABLE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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 (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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Kringle, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23HL159240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-0059

Identifier Type: -

Identifier Source: org_study_id