Clinical trial NCT03083652: Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Official title: Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness Myopathy
Keywords: physiotherapy
neuromuscular electrical stimulation
exercise capacity
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exercise capacity
timeFrame: <48h from ICU discharge
measure: Exercise capacity
timeFrame: 24h before hospital discharge
Secondary outcomes:
measure: Muscle strength
timeFrame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions)
measure: Muscle strength
timeFrame: <48 from ICU discharge
measure: Muscle strength
timeFrame: 24h before hospital discharge
measure: Muscle strength
timeFrame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions)
measure: Muscle strength
timeFrame: <48 from ICU discharge
measure: Muscle strength
timeFrame: 24h before hospital discharge
measure: Body composition (fat free mass)
timeFrame: <48h from inclusion
measure: Body composition (fat free mass)
timeFrame: <48 from ICU discharge
measure: Body composition (fat free mass)
timeFrame: 24h before hospital discharge
measure: Functional Capacity
timeFrame: <24h from inclusion
measure: Functional Capacity
timeFrame: 24h before hospital discharge
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Unidad de Vigilancia Intensiva Respiratoria (UVIR)
Study officials:
affiliation: Physiotherapist
name: Joan-Daniel Martí, Pt,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdellaoui A, Prefaut C, Gouzi F, Couillard A, Coisy-Quivy M, Hugon G, Molinari N, Lafontaine T, Jonquet O, Laoudj-Chenivesse D, Hayot M. Skeletal muscle effects of electrostimulation after COPD exacerbation: a pilot study. Eur Respir J. 2011 Oct;38(4):781-8. doi: 10.1183/09031936.00167110. Epub 2011 Feb 24.
citation: Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral muscle strength training in bed-bound patients with COPD receiving mechanical ventilation: effect of electrical stimulation. Chest. 2003 Jul;124(1):292-6. doi: 10.1378/chest.124.1.292.