Sepsis Trial of Early Physical Therapy Outside the ICU

NCT02159222 | Terminated

• 1 other identifier: UM-HUM00073474
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• 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.

• Employment status

  At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).

Other Outcomes (8)

• 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.

Study Arms (1)

Additional physical therapy

EXPERIMENTAL

Procedure: Additional physical therapy

Interventions

Additional physical therapy PROCEDURE

Additional physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Odden, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine, Medical School

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 9, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

US (1)