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

Not Applicable

Recruiting

• Conditions: Critical Illness Myopathy
• Interventions: Device: Neuromuscular electrical stimulation; Other: Sham

• Registration Number: NCT03083652
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-05
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Neuromuscular electrical stimulation	Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)
Control	Sham	Conventional physiotherapy with NMEs device not activated

Primary Outcome Measures

Name	Time	Method
Exercise capacity	24h before hospital discharge	Test sit-to-stand

Secondary Outcome Measures

Name	Time	Method
Muscle strength	24h before hospital discharge	MRC score and dynamometry
Body composition (fat free mass)	24h before hospital discharge	Bioelectrical impedance
Functional Capacity	24h before hospital discharge	Barthel scale

Trial Locations

Locations (1)

Unidad de Vigilancia Intensiva Respiratoria (UVIR); 🇪🇸 Barcelona, Spain