Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

NCT ID: NCT03765489

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-18
• Study Completion Date: 2018-06-21

Brief Summary

The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

Detailed Description

Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Conditions

Polyneuropathies; Septic Shock; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

electrical muscle stimulation

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction

Group Type: EXPERIMENTAL

electrical muscle stimulation

Intervention Type: DEVICE

electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction

conventional physical therapy

Intervention Type: PROCEDURE

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

conventional physical therapy

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

Group Type: ACTIVE_COMPARATOR

conventional physical therapy

Intervention Type: PROCEDURE

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

Interventions

electrical muscle stimulation

electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction

Intervention Type: DEVICE

conventional physical therapy

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
• Diagnosis of severe sepsis or septic shock
• More than 48 hours in VMI
• With sedation and / or neuromuscular blockade
• Autovalent prior to admission to the ICU

Exclusion Criteria

• Subjects from other hospitals / clinics or units of the hospital
• Multiple trauma
• Previous neuromuscular pathology
• Pacemaker users
• Pregnant women
• BMI> 35
• Epilepsy
• Those who have refused to sign informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

daniel arellano sepulveda

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OAIC 847/16

Identifier Type: -

Identifier Source: org_study_id