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Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

R

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

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

Trial contacts and locations

1

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Central trial contact

Lisa A Duffner, B.A.,B.S.; Amal Jubran, MD

Data sourced from clinicaltrials.gov

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