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Enrolling by invitation NCT06679803

Feasibility of a First-Line Physical Activity Intervention After Stroke

No phase Interventional Stroke Ischemic Stroke Hemorrhagic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Activity Chats after Stroke (PA-ChatS).
Who it may be relevant to
Registry conditions: Stroke, Ischemic Stroke, Hemorrhagic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 c

Primary outcome measures

  • Adherence to PA-ChatS sessions [Time frame: 6-weeks]
  • Adherence to wearable activity tracker [Time frame: 6-weeks]
Secondary outcome measures (8)
  • Acceptability of PA-ChatS Intervention [Time frame: Week 7]
  • Safety of the PA-ChatS intervention [Time frame: Week 7]
  • Change in step count [Time frame: Weeks 1 to 12]
  • Change in sedentary time [Time frame: Weeks 1 to 12]
  • Adherence to step count [Time frame: Week 24]
  • Adherence to sedentary time [Time frame: Week 24]
  • Adherence to moderate-to-vigorous physical activity [Time frame: Week 24]
  • Adherence to strength training [Time frame: Week 24]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT06679803 · KIN-2024-33389 · UM1TR004405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗