Neuromuscular Electrical Stimulation (NMES) as an Add-on Therapy for the Improvement of Dyspnea in Patients with Post-Covid Syndrome: a Protocol for a Phase II Randomized, Non-Pharmacological Intervention-Controlled, Double-Blind Study.

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Anusree Anil Kumar
https://orcid.org/0000-0002-3765-1750
Cristina Naqui Xicota
https://orcid.org/0000-0002-5491-0881
Anny Christina Chin
https://orcid.org/0000-0001-6943-0226
Julia De Conti Pelanda
https://orcid.org/0000-0002-4388-1640
Thiago De Oliveira Monaco
https://orcid.org/0000-0001-8538-5023
Lena Adbelhadi Abdelwahab Mohamed
https://orcid.org/0000-0002-9797-6952
Katia Adriana Varela Borges
Matias German Herrera
https://orcid.org/0000-0003-2055-7781
Sabrina Gonzalez Pina
https://orcid.org/0000-0002-2261-2927
Ricardo Xavier Noriega Espinoza
https://orcid.org/0000-0003-3622-974X
Mario Enrique Ochoa Prieto
https://orcid.org/0000-0002-3583-4000
Jose Manuel Orenday-Barraza
https://orcid.org/0000-0002-9089-4575
Monica Scarleth Paz Ramirez
https://orcid.org/0000-0003-4638-0486
Danielle Carolina Pimenta
https://orcid.org/0000-0001-6397-736X
Eliza Dalasso Ricardo
https://orcid.org/0000-0001-8953-8576
Ippolito Notarnicola
https://orcid.org/0000-0002-4828-8811
Aseel Abdulrahim Mohammed Sukik
https://orcid.org/0000-0002-3725-9281

Abstract

Introduction: To date, 501 million people have been infected with SARS-CoV-2, and the incidence of COVID-19 is still increasing as new variants develop. Beyond the well-known short-term consequences of morbimortality of the COVID-19 disease, multiple long-term sequelae have been identi-fied, which are referred to as Post COVID Syndrome (PCS). Dyspnea beyond three weeks from in-fection is the most common long-term symptom, and physical therapy is the standard care for those patients. Neuromuscular Electrical Stimulation (NMES) has been previously used to improve muscle weakness in different pulmonary diseases with promising results. Therefore, given the expected burden of disease, additional tools that seek to optimize patient care, which are easy to use and cost-effective, are a promising approach to PCS recovery. Objective: To compare the efficacy of NMES plus physical therapy against sham procedure and physical therapy in improving dyspnea among patients who developed PCS.


Methods: This trial will be a multicentric randomized sham-controlled, double-blinded parallel phase 2 superiority trial. Patients admitted to the hospital with moderate to severe COVID-19, who develop PCS, will be allocated to intervention and sham groups in a 1:1 ratio. They will be assessed for dyspnea through the 6-minute walk test (6MWT) for three months.


Conclusion: To our knowledge, no previous published literature tested the same intervention array as this study. Thus, the study assesses the possible impact of the proposed intervention to improve dyspnea among patients with PCS.


Keywords: COVID-19, Post-COVID Syndrome, Post-acute COVID, Long COVID, Neuromuscular Electrical Stimulation, Dyspnea.

Article Details

How to Cite
Anil Kumar, A., Naqui Xicota, C., Chin, A. C., De Conti Pelanda, J., De Oliveira Monaco, T., Mohamed, L. A. A. ., Varela Borges, K. A., German Herrera, M., Gonzalez Pina, S., Noriega Espinoza, R. X., Ochoa Prieto, M. E., Orenday-Barraza, J. M., Paz Ramirez, M. S., Pimenta , D. C., Dalasso Ricardo, E., Notarnicola, I., & Sukik, A. A. M. . (2022). Neuromuscular Electrical Stimulation (NMES) as an Add-on Therapy for the Improvement of Dyspnea in Patients with Post-Covid Syndrome: a Protocol for a Phase II Randomized, Non-Pharmacological Intervention-Controlled, Double-Blind Study. Principles and Practice of Clinical Research, 8(3), 19–28. https://doi.org/10.21801/ppcrj.2022.83.1
Section
Clinical Research Design

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