Feasibility of a First-Line Physical Activity Intervention After Stroke

NCT06679803 | Enrolling By Invitation

• 2 other identifiers: KIN-2024-33389UM1TR004405
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore a new intervention that supports physical activity within the first 6 weeks after stroke. All participants will complete assessments at weeks 0 and 7. During weeks 1 through 6, participants will use a Fitbit Inspire to track their step counts and meet with an occupational therapist one time per week. They will also complete weekly surveys. Physical activity levels will be measured using surveys and a wearable activPAL monitor 6 times during the study: Weeks 1, 3, 5, 7, 12, and 24.

Conditions

Hemorrhagic Stroke; Stroke; Ischemic Stroke

Keywords

physical activity; occupational therapy; behavioral intervention; stroke rehabilitation

Outcome Measures

Primary Outcomes (2)

• Adherence to PA-ChatS sessions

  Percentage of participants who complete 6 out of 6 (100%) of PA-ChatS sessions. Session completion will be documented by the study intervention therapist and total count of sessions completed will be computed after the last intervention session is delivered.

  6-weeks

• Adherence to wearable activity tracker

  Percentage of participants who use the wearable activity tracker (Fitbit Inspire 3) an average of 5 of 7 days/week during the 6-week intervention period. Data will be exported from Fitbit to compute average number of days per week the Fitbit was used.

  6-weeks

Secondary Outcomes (8)

• Acceptability of PA-ChatS Intervention

  Week 7

• Safety of the PA-ChatS intervention

  Week 7

• Change in step count

  Weeks 1 to 12

• Change in sedentary time

  Weeks 1 to 12

• Adherence to step count

  Week 24

Study Arms (1)

PA-ChatS Intervention

EXPERIMENTAL

Participants will receive 6, 20-30 minute intervention sessions delivered over the telephone by an occupational therapist over 6 weeks (1 session/week). They will also complete self-monitoring of step counts using a Fitbit Inspire.

Behavioral: Physical Activity Chats after Stroke (PA-ChatS)

Interventions

Physical Activity Chats after Stroke (PA-ChatS) BEHAVIORAL

PA-ChatS consists of (1) self-monitoring step count using a Fitbit Inspire, and (2) behavioral activation for stepping activity delivered via the telephone and guided by the PA-ChatS workbook. Participants will receive education regarding the physical activity after stroke, American Heart/Stroke Association guidelines for post-stroke physical activity levels, and an overview of the intervention activities. They will then use the Fitbit data to monitor average daily step counts, set a new step count goals (increasing by 5 to 10% of the daily average step count from the prior week), and create a specific plan for achieving the new step count goal. The interventionist will collaboratively problem solve with the participant to identify strategies to overcome barriers to stepping activity and maintain safety.

PA-ChatS Intervention

Eligibility Criteria

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

You may qualify if:

• Stroke diagnosis confirmed by imaging
• Admitted to Fairview Health System (Minnesota) at the time of study enrollment or discharged to a community-based setting from Fairview Health System within 3 months before study enrollment
• Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent

You may not qualify if:

• Discharge anticipated to a transitional care unit, skilled nursing facility, or other non-community-based care setting
• Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent
• Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)
• Comorbid cancer, currently undergoing chemotherapy or radiation treatment
• Received inpatient treatment or was hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
• Current diagnosis of a terimnal illness and/or receiving hospice care
• History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement
• Inability to speak, read, or understand English
• Concurrent participation in another rehabilitation intervention research study
• Resides more than 50 miles outside of the Twin Cities metropolitan area
• Investigator discretion for safety or adherence reasons

Sponsors & Collaborators

• University of Minnesota: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data and supporting documents will be made available upon reasonable request after the main results are published in a peer-reviewed journal.
• Access Criteria: Requests for data sharing may be directed to the Principal Investigator. Deidentified IPD and supporting will be provided upon reasonable request through appropriate channels (Data Use Agreement).

Locations

US (1)