Clinical trial NCT06679803: Feasibility of a First-Line Physical Activity Intervention After Stroke
Official title: PA-ChatS: Feasibility of Delivering a First-Line Physical Activity Intervention After Stroke
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Ischemic Stroke
Hemorrhagic Stroke
Keywords: physical activity
occupational therapy
behavioral intervention
stroke rehabilitation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-11-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adherence to PA-ChatS sessions
timeFrame: 6-weeks
measure: Adherence to wearable activity tracker
timeFrame: 6-weeks
Secondary outcomes:
measure: Acceptability of PA-ChatS Intervention
timeFrame: Week 7
measure: Safety of the PA-ChatS intervention
timeFrame: Week 7
measure: Change in step count
timeFrame: Weeks 1 to 12
measure: Change in sedentary time
timeFrame: Weeks 1 to 12
measure: Adherence to step count
timeFrame: Week 24
measure: Adherence to sedentary time
timeFrame: Week 24
measure: Adherence to moderate-to-vigorous physical activity
timeFrame: Week 24
measure: Adherence to strength training
timeFrame: Week 24
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Emily Kringle, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: