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CompletedNCT03765489Updated Dec 5, 2018

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

An interventional study of electrical muscle stimulation and conventional physical therapy in Polyneuropathies, Septic Shock and Muscle Weakness, sponsored by University of Chile. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by University of Chile · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jun 2018, 8 years 3 months ago, and no results have been posted to the registry.
  • Registered 1 year 11 months after the study started (first participant enrolled Nov 2016, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Polyneuropathies
  • Septic Shock
  • Muscle Weakness

Keywords

  • polyneuropathies
  • muscle weakness
  • sepsis
  • septic shock
  • electrical stimulation
  • intensive care unit
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 23 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    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

    Device: electrical muscle stimulation · Procedure: conventional physical therapy

  • Active comparator
    conventional physical therapy

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

    Procedure: conventional physical therapy

Interventions

  • Deviceelectrical 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

  • Procedureconventional physical therapy

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

06

What researchers measure

Primary outcomes

  1. intensive care unit acquired weakness

    Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness

    Time frame: at awakening of the subject, an average of 8 days

Secondary outcomes

  1. muscle strength

    Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).

    Time frame: at awakening of the subject, an average of 8 days

  2. muscle mass

    ultrasonography

    Time frame: at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days

  3. maximum inspiratory pressure

    maximum inspiratory pressure

    Time frame: at awakening of the subject, an average of 8 days

  4. days of mechanical ventilation

    number of days wirh mechanical ventilation

    Time frame: an average of 11 days

  5. Number of Participants with weaning failure

    Number of Participants who presented reintubation

    Time frame: 48 hours post extubation day

  6. days of ICU stay

    number of days in ICU

    Time frame: at ICU discharge, an average of 18 days

  7. mortality at 28 days

    mortality

    Time frame: at 28 days post ICU admission

  8. gait ability at hospital discharge

    presence or not of gait ability

    Time frame: at hospital discharge, an averange of 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Study protocol · Nov 17, 2016
  • Statistical analysis plan · Nov 17, 2016

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03765489
Lead sponsor
University of Chile
Responsible party
daniel arellano sepulveda (principal investigator, University of Chile) — Principal investigator
First posted
Dec 5, 2018
Start date
Nov 18, 2016
Primary completion
Jun 21, 2018
Completion
Jun 21, 2018
Last update
Dec 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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