Feasibility of a First-Line Physical Activity Intervention After Stroke
- Conditions
- StrokeIschemic StrokeHemorrhagic Stroke
- Registration Number
- NCT06679803
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 25
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adherence to PA-ChatS sessions 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.
Adherence to wearable activity tracker 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 Outcome Measures
Name Time Method Acceptability of PA-ChatS Intervention 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.
Safety of the PA-ChatS intervention 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.
Change in step count Weeks 1 to 12 The activPAL micro4 will be used to measure step count, following a 24-hour, 7-day wear protocol.
Change in sedentary time 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.
Adherence to step count 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.
Adherence to sedentary time 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.
Adherence to moderate-to-vigorous physical activity 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.
Adherence to strength training 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.
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States