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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Conventional physiotherapy with NMEs device not activated |
|
| Intervention | Experimental | Conventional physiotherapy with daily 30-minutes NMEs (5 days/week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | Device | Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Test sit-to-stand | <48h from ICU discharge |
| Exercise capacity | Test sit-to-stand | 24h before hospital discharge |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joan-Daniel MartÃ, PT,PhD | Contact | 0034932275400 | 4190 | jd.martibcn@gmail.com |
| Javi Martinez, PT | Contact | 0034687219761 | javimagu8@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joan-Daniel MartÃ, Pt,PhD | Physiotherapist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Vigilancia Intensiva Respiratoria (UVIR) | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21349913 | Background | 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. | |
| 12853536 | Result |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham | Other | Conventional physiotherapy with NMES device NOT activated |
|
| <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 |
| 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. |