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

Critical Illness Myopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03083652
• Other study ID #: UVIR
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Hospital Clinic of Barcelona
• Contact: Joan-Daniel Martí, PT,PhD
• Phone: 0034932275400
• Email: jd.martibcn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Myopathy

Intervention

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

Locations

Country	Name	City	State
Spain	Unidad de Vigilancia Intensiva Respiratoria (UVIR)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Test sit-to-stand	<48h from ICU discharge
Primary	Exercise capacity	Test sit-to-stand	24h before hospital discharge
Secondary	Muscle strength	MRC score	1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Secondary	Muscle strength	MRC score	<48 from ICU discharge
Secondary	Muscle strength	MRC score	24h before hospital discharge
Secondary	Muscle strength	Dynamometry	1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Secondary	Muscle strength	MRC score and dynamometry	<48 from ICU discharge
Secondary	Muscle strength	MRC score and dynamometry	24h before hospital discharge
Secondary	Body composition (fat free mass)	Bioelectrical impedance	<48h from inclusion
Secondary	Body composition (fat free mass)	Bioelectrical impedance	<48 from ICU discharge
Secondary	Body composition (fat free mass)	Bioelectrical impedance	24h before hospital discharge
Secondary	Functional Capacity	Barthel scale	<24h from inclusion
Secondary	Functional Capacity	Barthel scale	24h before hospital discharge