Hemorrhagic Stroke, Ischemic Stroke, Stroke
Conditions
Keywords
physical activity, behavior change, rehabilitation
Brief summary
The goal of this study is to explore the feasibility of a new approach to rehabilitation that focuses on step count. Participants will complete 6 telephone or Zoom-based sessions with an occupational therapist over 6 weeks and use a step count tracker during that time. They will also complete questionnaires, assessments, surveys, and physical activity measurements during study weeks 0 (baseline), 3 (mid-point), 7 (post-intervention) and 12 (follow-up).
Interventions
PA-ChatS consists of (1) self-monitoring step count using a pedometer, and (2) behavioral activation for stepping activity delivered via the telephone or Zoom and guided by the PA-ChatS workbook. Participants will receive education regarding physical activity after stroke, American Heart Association guidelines for post-stroke physical activity levels, and an overview of the intervention activities. They will then use a pedometer to monitor average daily step counts, set 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.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stroke diagnosis confirmed by imaging * Stroke occurred 6 or more months before study enrollment * Meet criteria for "inactive" on the International Physical Activity Questionnaire-Short Form * Able to identify a support person that they interact with in-person at least once per week * Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent
Exclusion criteria
* Currently receiving care in a transitional care unit, skilled nursing facility, or other institutional care setting * Currently receiving outpatient neurorehabilitation services (e.g., physical therapy, occupational therapy, speech therapy) * Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent) * Currently pregnant or expecting to become pregnant in the next 8 weeks 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 a psychiatric condition and/or alcohol or substance abuse within the past 12 months * Current diagnosis of a terminal illness and/or currently receiving hospice care * History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement * Uses wheelchair as primary mobility aid outside of home setting * 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, Minnesota metropolitan area * Investigator discretion for safety or adherence reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to step count | Week 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. The total count of adverse events that are possibly or definitely related to this intervention will be reported. |
| Adherence to step count | Week 12 | 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. |
| 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 7 | 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. |
Countries
United States
Contacts
CONTACTKarli Jahnke
PRINCIPAL_INVESTIGATOREmily Kringle, PhD, OTR/L
University of Minnesota
Outcome results
None listed