NCT02847988

Brief Summary

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

5.3 years

First QC Date

July 25, 2016

Last Update Submit

March 9, 2021

Conditions

Muscle Weakness

Keywords

muscle strengthmuscle functionfunctional status

Outcome Measures

Primary Outcomes (1)

  • Time to reach independence in performing functional activity

    Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)

    Hospital discharge, an expected average stay of 5 weeks

Secondary Outcomes (1)

  • The percentage of patients who can perform functional activities independently

    Hospital discharge, an expected average stay of 5 weeks

Study Arms (2)

Neuro-muscular electrical stimulation

ACTIVE COMPARATOR

Intervention:Neuromuscular electrical stimulation (NMES) NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES

Device: Neuromuscular electrical Stimulation (NMES)

Sham stimulation

SHAM COMPARATOR

Intervention: sham stimulation Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES

Device: Sham Stimulation

Interventions

Neuromuscular electrical Stimulation (NMES)DEVICE

Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction

Neuro-muscular electrical stimulation
Sham StimulationDEVICE

Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).

Sham stimulation

Eligibility Criteria

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

You may qualify if:

  • Duration of mechanical ventilation \>14 days
  • Sufficiently awake
  • Able to speak and comprehend English
  • Willingness to participate

You may not qualify if:

  • Cardiopulmonary Instability
  • Acute-onset neuromuscular disease
  • Lower-extremity amputee or paresis
  • Open wound at electrode application points
  • Pitting edema grade ≥3
  • Presence of pacemaker, implanted defibrillator, or ventricular-assist device
  • inability to transfer from sitting to standing before critical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Amal Jubran, MD

    RML Specialty Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Duffner, B.A.,B.S.

CONTACT

630-286-4149lmikolajewski@rmlspecialtyhospital.org

Amal Jubran, MD

CONTACT

708-202-2705ajubran@lumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator-Staff Physician

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2021

Study Completion

April 1, 2022

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)