跳至主要内容
临床试验/NCT06679803
NCT06679803
邀请入组
不适用

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

University of Minnesota1 个研究点 分布在 1 个国家目标入组 25 人2025年2月5日

概览

阶段
不适用
干预措施
Physical Activity Chats after Stroke (PA-ChatS)
疾病 / 适应症
Stroke
发起方
University of Minnesota
入组人数
25
试验地点
1
主要终点
Adherence to PA-ChatS sessions
状态
邀请入组
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2025年2月5日
结束日期
2026年12月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

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

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)

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)

研究点 (1)

Loading locations...

相似试验