Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Conditions
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Muscle Weakness

Intervention / Treatment
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* Device: Neuromuscular electrical Stimulation (NMES)
* Device: Sham Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuro-muscular electrical stimulation<br>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)<br>* 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<br>|
| Sham Comparator: Sham stimulation<br>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<br>* Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle strength, muscle function, functional status