SepsisSTEP TO ITNCT02159222
Sepsis Trial of Early Physical Therapy Outside the ICU
A study testing Additional physical therapy in people with Sepsis, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Additional physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Sepsis
- Being tested
- Additional physical therapy
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional physical therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Additional physical therapy | Experimental | Not described Receives: Procedure: Additional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Baseline ADLs will be assessed using chart review. 30 day follow-up ADL and iADL function will be assessed using a telephone survey
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Rohde, University of Michigan
- Investigators
- Andrew Odden, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159222
- Sponsor's protocol ID
- UM-HUM00073474
- Acronym
- STEP TO IT
- Status last verified
- Oct 2019
- First submitted
- 22 May 2014
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis Trial of Early Physical Therapy Outside the ICU: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT02159222
- Acronym / sponsor ID
- STEP TO IT / UM-HUM00073474
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional physical therapy | Experimental | Procedure: Additional physical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional physical therapy | Procedure or surgery | Additional physical therapy |
Primary outcome
Change from baseline ambulation
Time frame: 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.
6 secondary outcomes
Change in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (iADLs)
Time frame: At day 0 (baseline enrollment) and day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days)
Discharge location
Time frame: At day 5 (assessed at discharge; predicted average length of stay is 5 days)
ICU Transfer Rate
Time frame: Participants will be followed for the duration of their hospitalization, an average length of stay of 5 days.
Length of stay
Time frame: Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Employment status
Time frame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Post-hospitalization physical function
Time frame: At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
Related trials for Sepsis
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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Odden, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional physical therapy in people with Sepsis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline ambulation (time frame: At day 0 (baseline enrollment) and for the duration of the participants' hospitalization, a predicted average length of stay of 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.