Sepsis Trial of Early Physical Therapy Outside the ICU (STEP TO IT)

Sepsis Trial of Early Physical Therapy Outside the ICU: A Pilot Feasibility Study

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).

Study Overview

• Status: Terminated
• Conditions: Sepsis
• Intervention / Treatment: Procedure: Additional physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional physical therapy	Procedure: Additional physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline ambulation	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.	At day 0 (baseline enrollment) and for the duration of the participants' hospitalization, a predicted average length of stay of 5 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (iADLs)	Baseline ADLs will be assessed using chart review. 30 day follow-up ADL and iADL function will be assessed using a telephone survey	At day 0 (baseline enrollment) and day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days)
Discharge location	The location of discharge (home, subacute rehabilitation facility, skilled nursing facility) will be assessed at discharge for all patients enrolled in the study.	At day 5 (assessed at discharge; predicted average length of stay is 5 days)
ICU Transfer Rate	The rate at which patients require transfer to the ICU will be assessed.	Participants will be followed for the duration of their hospitalization, an average length of stay of 5 days.
Length of stay	The length of stay will be recorded for patients enrolled in the trial.	Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Employment status	For patients employed for pay prior to the index admission, employment status will be assessed by telephone survey 30 days post-discharge.	At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Post-hospitalization physical function	Patients' physical function will be assessed 30 days after discharge using the SF-10 instrument.	At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission		At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
In-Hospital Mortality		Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days
Falls		Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Arrhythmia	Clinically significant arrhythmias occurring during therapy sessions will be documented and recorded as a safety outcome.	During each study protocol physical therapy session while hospitalized
Pressure ulcers	The presence and severity of pressure ulcers will be recorded.	Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Cognitive function	Enrolled patients' cognitive function will be assessed using the TICS-m instrument	At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Depression	Patients will be screened for depression using the PHQ-2 instrument as part of the follow-up telephone survey.	At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
30-Day Post-Hospitalization Mortality		At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Andrew Odden, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: UM-HUM00073474