Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth

NCT05029284 | Completed Results

• 2 other identifiers: 2021-0059K23HL159240
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  week 8

Secondary Outcomes (3)

• Change in Participation Restrictions

  week 0 to week 8

• Change in Health-Related Quality of Life

  week 0 to week 8

• Change in Sedentary Minutes

  week 0 to week 8

Study Arms (1)

teleABLE

EXPERIMENTAL

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

Behavioral: teleABLE

Interventions

teleABLE 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.

teleABLE

Eligibility Criteria

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

You may qualify if:

• 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

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 (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

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Emily Kringle
• Organization: University of Minnesota

ekringle@umn.edu

(612) 624-8994

Study Officials

• Emily Kringle, PhD, OTR/L

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 31, 2021
• Study Start: December 20, 2021
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Locations

US (1)