The Influences of Early Mobilization on Myokines, Body Composition and Outcomes in ICU Septic Patients

Study Overview
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Brief Summary
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the investigators' preliminary data revealed that early physical therapy in patients with sepsis in ICU could promote recovery of function (liver and kidney) and decrease the length of stay in hospitalization. The levels of plasma IL-6 and IL-10 were higher in non-survival group than in survival group. the investigators hypothesize that myokines and body composition parameters are related to the prognosis of sepsis.the investigators will investigate the influences of duration and intensity of early mobilization on myokines, body composition and outcomes of septic patients in intensive care. The proposed study can help precision medicine in the future.

Detailed Description
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The septic patients admitted to the intensive care unit (ICU) will be divided into three groups. One is non-PT group, with no physical treatment intervention (group 1), Early-PT group with physical treatment intervention started in ICU admission day 3 (group 2), and Delayed-PT with physical treatment intervention started after ICU admission day 3 (group 3). The grouping will be based on clinical indication for early mobilization (physical therapy) as below. The body composition data (of day 1, 3, 8) of the patients in the three groups will be measured, and the residual blood from day 1 and day 8 will be collected for detecting myokines.

Official Title
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The Influences of Duration and Intensity of Early Mobilization on Myokines, Body Composition and Outcomes of Septic Patients in Intensive Care Unit

Conditions
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Sepsis

Intervention / Treatment
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* Behavioral: early mobilization (physical therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Aadmission in ICU 2. Clinical diagnosis of sepsis Exclusion Criteria: 1. Expired in 3-days 2. Cardiac stents or pacemakers 3. Airborne disease 4. Contact-transmitted disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: non-PT group<br>with no physical treatment intervention (group 1) | |
| Experimental: Early-PT group<br>with physical treatment intervention started in ICU admission day 3 (group 2) | Behavioral: early mobilization (physical therapy)<br>* The investigators will consult rehabilitation department for Physical Therapy and patients will be grouped as clinically allocation. Protocols for consideration of initiation The timing is 72 hours after admission to ICU, early mobilization doses and duration is as the protocol of rehabilitation department<br>|
| Experimental: Delayed-PT<br>with physical treatment intervention started after ICU admission day 3 (group 3) | Behavioral: early mobilization (physical therapy)<br>* The investigators will consult rehabilitation department for Physical Therapy and patients will be grouped as clinically allocation. Protocols for consideration of initiation The timing is 72 hours after admission to ICU, early mobilization doses and duration is as the protocol of rehabilitation department<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Status of survival or mortality at the time discharged from ICU | The day discharged from ICU, through study completion, an average of 1 year. | 
| Hospital mortality | Status of survival or mortality at the time discharged from hospital | The day discharged from hospital, through study completion, an average of 1 year. | 
| 7-day mortality | Status of survival or mortality at Day 7 during hospital stay | Day 7 after hospital admission | 
| 28-day mortality | Status of survival or mortality at Day 28 during hospital stay | Day 28 after hospital admission | 
| 90-day mortality | Status of survival or mortality at Day 90 during hospital stay | Day 90 after hospital admission | 
| ICU Days | length of ICU stay | During hospitalization, through study completion, an average of 1 year. | 
| Change of white blood cell between day 1 and day 8 | assessing the change of white blood cell count between day 1 and day 8 | Day 1 and Day8 after ICU admission | 
| Ventilation days | Total using days of mechanical ventilation | During hospitalization, through study completion, an average of 1 year. | 
| Change of percentage of body fat between day 1 and day 8 | assessing the change of percentage of body fat between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA) | Day 1 and Day 8 after ICU admission | 
| Change of total body water between day 1 and day 8 | assessing the change of total body water between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA) | Day 1 and Day 8 after ICU admission | 
| Change of soft lean mass between day 1 and day 8 | assessing the change of soft lean mass between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA) | Day 1 and Day 8 after ICU admission | 
| Concentration of serum IL-6 change between day 1 and day 8 | assessing the change of IL-6 between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA) | Day 1 and Day 8 after ICU admission | 
| Concentration of serum BDNF change between day 1 and day 8 | assessing the change of serum BDNF between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA) | Day 1 and Day 8 after ICU admission | 
| Concentration of serum IL-15 change between day 1 and day 8 | assessing the change of serum IL-15 between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA) | Day 1 and Day 8 after ICU admission | 
| Concentration of serum SPARC change between day 1 and day 8 | assessing the change of serum SPARC (secreted protein acidic and rich in cysteine) between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA) | Day 1 and Day 8 after ICU admission | 
| Concentration of serum Irisin change between day 1 and day 8 | assessing the change of serum Irisin between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA) | Day 1 and Day 8 after ICU admission | 
| Concentration of serum Myostatin change between day 1 and day 8 | assessing the change of serum Myostatin between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA) | Day 1 and Day 8 after ICU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, early mobilization, myokines, body composition