MedDataX Logo

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

NCT ID: NCT06061224

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sepsis early mobilization myokines body composition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-PT group

with no physical treatment intervention (group 1)

Group Type NO_INTERVENTION

No interventions assigned to this group

Early-PT group

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

Group Type EXPERIMENTAL

early mobilization (physical therapy)

Intervention Type BEHAVIORAL

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

Delayed-PT

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

Group Type EXPERIMENTAL

early mobilization (physical therapy)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

early mobilization (physical therapy)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

FANG WEN-FENG

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

FANG WEN-FENG

Role: CONTACT

Phone: +886 7 731 7123

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

WEN-FENG Fang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202102342B0

Identifier Type: -

Identifier Source: org_study_id