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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness Myopathy
• Intervention / Treatment: Other: Sham; Device: Neuromuscular electrical stimulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joan-Daniel Martí, PT,PhD; Phone Number: 4190 0034932275400; Email: jd.martibcn@gmail.com
• Study Contact Backup: Name: Javi Martinez, PT; Phone Number: 0034687219761; Email: javimagu8@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Unidad de Vigilancia Intensiva Respiratoria (UVIR)
    • Contact: Antoni Torres, Dr; Phone Number: 4190 0034932275400; Email: atorres@clinic.ub.es
    • Contact: Miquel Ferrer, Dr; Phone Number: 4190 0034932275400; Email: miferrer@clinic.ub.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Joan-Daniel Martí, Pt,PhD, Physiotherapist

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: exercise capacity; neuromuscular electrical stimulation; physiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: UVIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No