PA-ChatS: Feasibility of Delivering a First-Line Physical Activity Intervention After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Adherence to PA-ChatS sessions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PA-ChatS Intervention
Participants will receive 6, 20-30 minute intervention sessions delivered over the telephone by an occupational therapist over 6 weeks (1 session/week). They will also complete self-monitoring of step counts using a Fitbit Inspire.
干预措施: Physical Activity Chats after Stroke (PA-ChatS) (Behavioral)
结局指标
主要结局
Adherence to PA-ChatS sessions
时间窗: 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
时间窗: 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.
次要结局
- Acceptability of PA-ChatS Intervention(Week 7)
- Safety of the PA-ChatS intervention(Week 7)
- Change in step count(Weeks 1 to 12)
- Change in sedentary time(Weeks 1 to 12)
- Adherence to step count(Week 24)
- Adherence to sedentary time(Week 24)
- Adherence to moderate-to-vigorous physical activity(Week 24)
- Adherence to strength training(Week 24)