Clinical trial NCT02159222: Sepsis Trial of Early Physical Therapy Outside the ICU
Official title: Sepsis Trial of Early Physical Therapy Outside the ICU: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline ambulation
timeFrame: At day 0 (baseline enrollment) and for the duration of the participants' hospitalization, a predicted average length of stay of 5 days.
Secondary outcomes:
measure: Change in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (iADLs)
timeFrame: At day 0 (baseline enrollment) and day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days)
measure: Discharge location
timeFrame: At day 5 (assessed at discharge; predicted average length of stay is 5 days)
measure: ICU Transfer Rate
timeFrame: Participants will be followed for the duration of their hospitalization, an average length of stay of 5 days.
measure: Length of stay
timeFrame: Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
measure: Employment status
timeFrame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
measure: Post-hospitalization physical function
timeFrame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Other outcomes:
measure: Readmission
timeFrame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
measure: In-Hospital Mortality
timeFrame: Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days
measure: Falls
timeFrame: Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
measure: Arrhythmia
timeFrame: During each study protocol physical therapy session while hospitalized
measure: Pressure ulcers
timeFrame: Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
measure: Cognitive function
timeFrame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
measure: Depression
timeFrame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
measure: 30-Day Post-Hospitalization Mortality
timeFrame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Andrew Odden, MD
role: PRINCIPAL_INVESTIGATOR
References: