NCT03815994

Brief Summary

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

November 13, 2018

Last Update Submit

February 2, 2021

Conditions

Critical CareRehabilitation

Keywords

Physical therapy modalities,Electric stimulation therapyIndirect calorimetry

Outcome Measures

Primary Outcomes (1)

  • Change of Oxygen consumption (VO2),from baseline and interventions.

    Change of Oxygen consumption (VO2) will be evaluated by calorimetry

    VO2 will be taken during the each intervention, it will be taken only the first day

Secondary Outcomes (1)

  • Change of Carbon dioxide production (VCO2) from baseline and interventions.

    VCO2 will be taken during the each intervention, it will be taken only the first day

Other Outcomes (1)

  • Change of Resting energy expenditure (REE) from baseline and interventions.

    REE will be taken during the each intervention, it will be taken only the first day

Study Arms (2)

Experimental: group 1

EXPERIMENTAL

Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.

Device: Neuromuscular Electrical Stimulation

group 2

SHAM COMPARATOR

Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation.

Device: Neuromuscular Electrical Stimulation

Interventions

Neuromuscular Electrical StimulationDEVICE

This device produces a muscle contraction in response to a externally generated low-voltage electric impulse, which is conducted through electrodes placed on the skin over the muscle group to be stimulated.

Also known as: Functional Electrical Stimulation
Experimental: group 1group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients that will be admitted to the intensive care unit
  • Hemodynamic stability
  • Mechanical ventilation.

You may not qualify if:

  • In general:
  • a. Pregnant women
  • b. Brain death
  • c. Neuromuscular diseases
  • d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.
  • Contraindications for the use of NMES:
  • a. Fractures
  • b. Burns
  • c. Skin lesions
  • d. Systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours)
  • e. Lower limb amputations
  • f. Cardiac pacemaker,
  • g. Thrombocytopenia less than 20,000/mm3
  • h. BMI greater than 35 kg/m2
  • i. Important lower extremity oedema
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

  • Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.

    PMID: 35176099DERIVED

Study Officials

  • Ada C Gastaldi, PhD

    Ribeirao Preto Medicine School-University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2018

First Posted

January 25, 2019

Study Start

November 13, 2018

Primary Completion

January 6, 2020

Study Completion

January 29, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification, will be available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will be available immediately following publication and for five years.
Access Criteria
The data will be available from the principal investigator upon reasonable request.

Locations

BR(1)