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Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis

NCT03406494 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2018-01-23

No results posted yet for this study

Summary

Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some subsequent complications developed in the ICU rather than original disease, e.g., ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a majority of ICU settings across China. This study is aimed to examine whether a multi-component physical therapy (PT) program against these lethal ICU-related complications could reduce ICU 28-day mortality, improve independent functional status and 1-year survival in this subset of patients.

Conditions

Interventions

OTHER

Early multicomponent physical therapy program

1. Positioning (upright bed standing; turning, moving on bed). 2. Peripheral muscle strength training (active or passive full range of motion, lower extremities ergometer cycling). 3. Respiratory muscle training (supine abdominal breathing training). 4. Neuromuscular electrical stimulation (NMES) on target muscles (bilateral bicipital muscles, quadriceps femoris muscles and rectus femoris). 5. Gut rehabilitation (midfrequency NMES; abdominal manual or vibration massage).

Sponsors & Collaborators

  • Southern Medical University, China

    collaborator OTHER

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Yan Zhang · Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2020-12-31
Completion
2021-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406494 on ClinicalTrials.gov