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Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Primary Purpose

Muscle Weakness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical Stimulation (NMES)
Sham Stimulation
Sponsored by
RML Specialty Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring muscle strength, muscle function, functional status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RML Specialty HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Neuro-muscular electrical stimulation

Sham stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to reach independence in performing functional activity
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)

Secondary Outcome Measures

The percentage of patients who can perform functional activities independently
Percentage of patients with an FSS-ICU score ≥ 25 at discharge from LTACH

Full Information

First Posted
July 25, 2016
Last Updated
March 9, 2021
Sponsor
RML Specialty Hospital
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02847988
Brief Title
Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
Official Title
Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RML Specialty Hospital
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
muscle strength, muscle function, functional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuro-muscular electrical stimulation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical Stimulation (NMES)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).
Primary Outcome Measure Information:
Title
Time to reach independence in performing functional activity
Description
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)
Time Frame
Hospital discharge, an expected average stay of 5 weeks
Secondary Outcome Measure Information:
Title
The percentage of patients who can perform functional activities independently
Description
Percentage of patients with an FSS-ICU score ≥ 25 at discharge from LTACH
Time Frame
Hospital discharge, an expected average stay of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa A Duffner, B.A.,B.S.
Phone
630-286-4149
Email
lmikolajewski@rmlspecialtyhospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Jubran, MD
Phone
708-202-2705
Email
ajubran@lumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Jubran, MD
Organizational Affiliation
RML Specialty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RML Specialty Hospital
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Duffner
Phone
630-286-4149
Email
lmikolajewski@rmlspecialtyhospital.org
First Name & Middle Initial & Last Name & Degree
Maryann Oliver
Phone
630-286-4127
First Name & Middle Initial & Last Name & Degree
Amal Jubran, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

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