Sepsis Trial of Early Physical Therapy Outside the ICU: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from baseline ambulation
研究概览
简要总结
The purpose of this study is to determine whether an additional physical therapy program can improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an illness in which the body has a severe response to bacteria or other germs and develops worsened function of a major organ such as the kidneys, heart, or lungs).
详细描述
Patients who are admitted to the hospitalist service at the University of Michigan Hospital will be screened for the presence of severe sepsis. Those who are deemed eligible and provide consent will be enrolled. Study patients will receive additional physical therapy according to a protocol developed for this study in addition to the usual care recommended by their regular treating physician. Additional treatments will be individualized based on enrolled patients' baseline physical function and progress and may include standing, stretching, transferring, and walking - either with assistance or independently. Treating therapists have been trained in the use of the protocol and individualization to maintain the highest standard of patient safety. Patients will be contacted 30 days after discharge to answer questions about their health and ability to perform routine tasks at home.
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
- •Any English-speaking patient over the age of 18 who is currently admitted to a general care floor under the care of the Medicine Faculty Hospitalist Service at the University of Michigan Health System and has severe sepsis is eligible to take part in this study.
排除标准
- •Subjects must be deemed by the study team to give informed consent by being able to state the basic purpose of the study. Consent by a legally authorized representative (LAR) will not be sought.
研究组 & 干预措施
Additional physical therapy
干预措施: Additional physical therapy (Procedure)
结局指标
主要结局
Change from baseline ambulation
时间窗: At day 0 (baseline enrollment) and for the duration of the participants' hospitalization, a predicted average length of stay of 5 days.
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days. This outcome will be assessed at baseline and at each study protocol physical therapy session during the index hospitalization.
次要结局
- Discharge location(At day 5 (assessed at discharge; predicted average length of stay is 5 days))
- ICU Transfer Rate(Participants will be followed for the duration of their hospitalization, an average length of stay of 5 days.)
- Length of stay(Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.)
- Change in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (iADLs)(At day 0 (baseline enrollment) and day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days))
- Employment status(At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).)
- Post-hospitalization physical function(At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).)
研究者
Jeffrey Rohde
Associate Professor of Internal Medicine, Medical School
University of Michigan