Feasibility of a First-Line Physical Activity Intervention After Stroke

NCT ID: NCT06679803

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-06-30

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

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Study Design

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

Study Groups

PA-ChatS Intervention

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.

Group Type: EXPERIMENTAL

Physical Activity Chats after Stroke (PA-ChatS)

Intervention Type: 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.

Interventions

Physical Activity Chats after Stroke (PA-ChatS)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 10 days before study enrollment
• Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent

Exclusion Criteria

• 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

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

Sponsors

National Center for Advancing Translational Sciences (NCATS)

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

Other Identifiers

UM1TR004405

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KIN-2024-33389

Identifier Type: -

Identifier Source: org_study_id