Feasibility of a First-Line Physical Activity Intervention After Stroke (PA-ChatS)

PA-ChatS: Feasibility of Delivering a First-Line Physical Activity Intervention After Stroke

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Intervention / Treatment: Behavioral: Physical Activity Chats after Stroke (PA-ChatS)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 3 months 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of PA-ChatS Intervention	The Client Satisfaction Questionnaire-8 will be used to measure acceptability of the intervention. This is an 8-item measure with each item rated on a 1 to 4-point Likert-type scale, and then averaged across all 8 items. A mean score of 3 or more indicates that the intervention is generally acceptable.	Week 7
Safety of the PA-ChatS intervention	All participants will be queried regarding possible adverse events during the study at one time-point using an adverse events questionnaire previously administered in physical activity studies after stroke.	Week 7
Change in step count	The activPAL micro4 will be used to measure step count, following a 24-hour, 7-day wear protocol.	Weeks 1 to 12
Change in sedentary time	The activPAL micro4 will be used to measure sedentary time, following a 24-hour, 7-day wear protocol. Participants will complete a daily diary indicating the sleep time. Sleep will be removed following a diary-informed method.	Weeks 1 to 12
Adherence to step count	The activPAL micro4 (24/7 wear protocol) will used to measure step count. The proportion of participants achieving 7500 or more steps per day will be reported.	Week 24
Adherence to sedentary time	The activPAL micro4 (24/7 wear protocol) will used to measure sedentary time. Participants will complete a diary to indicate sleep time, and sleep will be removed following a diary-informed method. The proportion of participants achieving 7 hours or less of sedentary time per day will be reported.	Week 24
Adherence to moderate-to-vigorous physical activity	The International Physical Activity Questionnaire will used to measure minutes per week of moderate-to vigorous-physical activity (MVPA). The proportion of participants achieving 90 minutes or more/week of MVPA will be reported.	Week 24
Adherence to strength training	The Muscle-Strengthening Exercise Questionnaire Short Form will used to measure days per week of strength training. The proportion of participants achieving 2 or more days per week of strength training will be reported.	Week 24

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Emily Kringle, PhD, OTR/L, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; behavioral intervention; occupational therapy; stroke rehabilitation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Ischemic Stroke; Hemorrhagic Stroke; Stroke; Motor Activity
• Other Study ID Numbers: KIN-2024-33389; UM1TR004405 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data related to demographics, medical and stroke history, cognitive function, mobility, self-reported psychosocial and social support measures, and physical activity data may be requested.
• IPD Sharing 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No