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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Sepsis

Treatments: Behavioral: early mobilization (physical therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06061224

202102342B0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

non-PT group

No Intervention group

Description:

with no physical treatment intervention (group 1)

Early-PT group

Experimental group

Description:

with physical treatment intervention started in ICU admission day 3 (group 2)

Treatment:

Behavioral: early mobilization (physical therapy)

Delayed-PT

Experimental group

Description:

with physical treatment intervention started after ICU admission day 3 (group 3)

Treatment:

Behavioral: early mobilization (physical therapy)