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

NCT03083652 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

  • Critical Illness Myopathy

Interventions

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Joan-Daniel Martí, Pt,PhD · Physiotherapist

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083652 on ClinicalTrials.gov