Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06679803

Feasibility of 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adherence to PA-ChatS sessions

    Time frame: 6-weeks

    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.

  2. Adherence to wearable activity tracker

    Time frame: 6-weeks

    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.

Secondary outcomes

  1. Acceptability of PA-ChatS Intervention

    Time frame: Week 7

    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.

  2. Safety of the PA-ChatS intervention

    Time frame: Week 7

    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.

  3. Change in step count

    Time frame: Weeks 1 to 12

    The activPAL micro4 will be used to measure step count, following a 24-hour, 7-day wear protocol.

  4. Change in sedentary time

    Time frame: Weeks 1 to 12

    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.

  5. Adherence to step count

    Time frame: Week 24

    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.

  6. Adherence to sedentary time

    Time frame: Week 24

    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.

  7. Adherence to moderate-to-vigorous physical activity

    Time frame: Week 24

    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.

  8. Adherence to strength training

    Time frame: Week 24

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Acronym: PA-ChatS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.