Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

March 9, 2021 updated by: Amal Jubran, RML Specialty Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • RML Specialty Hospital
        • Contact:
        • Contact:
          • Maryann Oliver
          • Phone Number: 630-286-4127
        • Principal Investigator:
          • Amal Jubran, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuro-muscular electrical stimulation

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)
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
Sham Comparator: Sham stimulation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach independence in performing functional activity
Time Frame: Hospital discharge, an expected average stay of 5 weeks
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)
Hospital discharge, an expected average stay of 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patients who can perform functional activities independently
Time Frame: Hospital discharge, an expected average stay of 5 weeks
Percentage of patients with an FSS-ICU score ≥ 25 at discharge from LTACH
Hospital discharge, an expected average stay of 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RML Specialty Hospital

Collaborators

National Institute of Nursing Research (NINR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXJ014
  • R01NR016055 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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