Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Not Applicable

• Conditions: Muscle Weakness
• Interventions: Device: Neuromuscular electrical Stimulation (NMES); Device: Sham Stimulation

• Registration Number: NCT02847988
• Lead Sponsor: RML Specialty Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11
• Primary Completion: 2021-11
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuro-muscular electrical stimulation	Neuromuscular electrical Stimulation (NMES)	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
Sham stimulation	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

RML Specialty Hospital; 🇺🇸 Hinsdale, Illinois, United States