Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

RML Specialty Hospital

Status: Unknown

Conditions: Muscle Weakness

Treatments: Device: Neuromuscular electrical Stimulation (NMES); Device: Sham Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02847988

R01NR016055 (U.S. NIH Grant/Contract)

AXJ014

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Neuro-muscular electrical stimulation

Active Comparator group

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

Treatment:

Device: Neuromuscular electrical Stimulation (NMES)

Sham stimulation

Sham Comparator group

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

Treatment:

Device: Sham Stimulation