Feasibility of a First-Line Physical Activity Intervention After Stroke

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Adherence to PA-ChatS sessions [Срок оценки: 6-weeks]
• Adherence to wearable activity tracker [Срок оценки: 6-weeks]

Вторичные конечные точки (8)

• Acceptability of PA-ChatS Intervention [Срок оценки: Week 7]
• Safety of the PA-ChatS intervention [Срок оценки: Week 7]
• Change in step count [Срок оценки: Weeks 1 to 12]
• Change in sedentary time [Срок оценки: Weeks 1 to 12]
• Adherence to step count [Срок оценки: Week 24]
• Adherence to sedentary time [Срок оценки: Week 24]
• Adherence to moderate-to-vigorous physical activity [Срок оценки: Week 24]
• Adherence to strength training [Срок оценки: Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06679803 · KIN-2024-33389 · UM1TR004405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗