NCT03083652

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness Myopathy

Interventions

Type	Name	Description
DEVICE	Neuromuscular electrical stimulation	Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus
OTHER	Sham	Conventional physiotherapy with NMES device NOT activated

Timeline

• Start date: 2017-02-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2017-03-20
• Last updated: 2023-11-07

Locations

1 site across 1 country: Spain