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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional physical therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional physical therapy | Procedure |
|
| 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. |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Odden, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| 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). |
| 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). |
| D013568 |
| Pathological Conditions, Signs and Symptoms |