Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Critical Illness Myopathy

Treatments: Device: Neuromuscular electrical stimulation; Other: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03083652

UVIR

Details and patient eligibility

About

Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Main objective: To evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional NMES applied only during the ICU stay on exercise capacity. Design: Randomized, controlled, double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h. Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. Patients in the control group will follow the same protocol but the device will not be activated. Measures: Demographic data, body composition through bioelectrical impedance analysis (BIA), and functional capacity before admission through Barthel scale will be registered upon inclusion. Exercise capacity through test sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry, body composition through BIA, and functional capacity through Barthel scale will be obtained at ICU and hospital discharge.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis at admission: acute or acute on chronic respiratory disease
• Mechanical ventilation > 72h at inclusion
• Expected mechanical ventilation > 24h
• Informed consent

Exclusion criteria

• Patients re-admitted to ICU (no hospital discharge)
• Exitus or transfer to another service/hospital
• Respiratory instability [Inspired fraction of oxygen (FIO2) >60% or positive end-expiratory pressure (PEEP) >10 cmH2O] and/or hemodynamic instability [Mean arterial pressure ( MAP)<60mmHg although vasoactive drugs] during > 24h.
• Pregnancy
• Neuromuscular disease before admission
• Skin lesions
• Limitation of therapeutic effort
• Mental and/or physical limitation to understand/realize tests for evaluation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Control

Sham Comparator group

Description:

Conventional physiotherapy with NMEs device not activated

Treatment:

Other: Sham

Intervention

Experimental group

Description:

Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)

Treatment:

Device: Neuromuscular electrical stimulation