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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness Myopathy

Intervention / Treatment
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* Device: Neuromuscular electrical stimulation
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Conventional physiotherapy with NMEs device not activated | Other: Sham<br>* Conventional physiotherapy with NMES device NOT activated<br>|
| Experimental: Intervention<br>Conventional physiotherapy with daily 30-minutes NMEs (5 days/week) | Device: Neuromuscular electrical stimulation<br>* Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Test sit-to-stand | <48h from ICU discharge | 
| Exercise capacity | Test sit-to-stand | 24h before hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | MRC score | 1st day in which collaboration of the patient is ensured (through standardized 5 questions) | 
| Muscle strength | MRC score | <48 from ICU discharge | 
| Muscle strength | MRC score | 24h before hospital discharge | 
| Muscle strength | Dynamometry | 1st day in which collaboration of the patient is ensured (through standardized 5 questions) | 
| Muscle strength | MRC score and dynamometry | <48 from ICU discharge | 
| Muscle strength | MRC score and dynamometry | 24h before hospital discharge | 
| Body composition (fat free mass) | Bioelectrical impedance | <48h from inclusion | 
| Body composition (fat free mass) | Bioelectrical impedance | <48 from ICU discharge | 
| Body composition (fat free mass) | Bioelectrical impedance | 24h before hospital discharge | 
| Functional Capacity | Barthel scale | <24h from inclusion | 
| Functional Capacity | Barthel scale | 24h before hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physiotherapy, neuromuscular electrical stimulation, exercise capacity