INTRODUCTION: Coronavirus 2019 disease (COVID-19), caused by the Severe Acute RespiratorySyndrome (SRAG) of coronavirus 2 (SARS-CoV-2) surpassed the global number of 119,603,761cases, with more than 2,649,722 reported deaths . There is sufficient evidence for apossible post-covid-19 syndrome, designating sequelae with persistent symptoms.Respiratory muscle training improves respiratory muscle strength, exercise capacity,diaphragm muscle thickness, and dyspnea in various patient populations, especially inthose with the greatest reduction in basal respiratory muscle strength. OBJECTIVE: Toevaluate the effectiveness of a home inspiratory muscle training protocol in improvingrespiratory muscle strength, dyspnea and quality of life in post-Covid-19 patients.MATERIALS AND METHODS: This is a clinical, controlled, randomized and blind trial, whichwill be carried out at the Institute of Tropical Medicine of the Federal University ofRio Grande do Norte. The sample size will be performed using GPower software version3.1.9.2 (Kiel, Germany) for Windows and will be established after conducting a pilotstudy with 5 participants in each group (total of 10 subjects) for a hypothetical two-wayANOVA test, using the main variable the Maximum Inspiratory Pressure (PImax.). Thesubjects included in the research will undergo three evaluation moments: Pre-training(Initial), Post-training (6 weeks) and Retention Test (24 weeks) for clinical evaluationform, anthropometric measures, respiratory muscle strength, volumes and capacitiespulmonary symptoms, dyspnea, perceived exertion and fatigue, handgrip strength,six-minute walk test, anxiety and depression, post-covid functional status. After theinitial assessment, all volunteers will receive a POWERbreathe® device (POWERbreathe®,HaB Ltd, Southam, UK) to carry out the training. EXPECTED RESULTS: provide a safe,effective and easy-to-perform treatment for post-covid-19 patients.
The subjects included in the research will go through three evaluation moments:
Pre-training (Initial), Post-training (3 and 6 weeks) and Retention Test (12 and 24
weeks).
After recruitment, participants will be invited to attend the Institute of Tropical
Medicine to carry out an initial assessment by an evaluator previously trained and
blinded to the intervention allocation group and will include anamnesis and physical
examination, with measurement of vital signs, anthropometric measurements, assessment of
lung volumes, respiratory muscle strength, peripheral muscle strength, quality of life,
anxiety and depression, functional status and the 6-minute walk test.
After the initial evaluation, all volunteers will receive a POWERbreathe® device
(POWERbreathe®, HaB Ltd, Southam, UK), to carry out the training, and will be
individually instructed on how to use it and on the performance of the protocol. They
will conduct an experimental session to familiarize themselves with the device that will
not be considered for review. Every three days, volunteers will receive a phone call from
researcher 2, who will not participate in the assessment, to confirm whether the exercise
with the POWERbreathe® was being performed properly at the frequency and load set and if
there were any doubts regarding the protocol. At the end of each week, participants will
receive a video call from researcher 2 to adjust the device according to the weekly load
progression of G1.
All evaluation moments (pre-training, post-training and retention test) will be performed
by a single evaluator (Evaluator 1) - who will not know which group the subject will be
allocated to - and recorded in the evaluation form developed for the project. A second
researcher (Evaluator 2) will be responsible for applying the training protocols to the
subjects.
Device: Inspiratory muscle training
Individuals will be instructed to perform a rapid contraction of the inspiratory muscles
against a load and sustain it for 2 seconds in each maneuver.
Inclusion Criteria:
- subjects of both sexes, sedentary, within two months of a diagnosis of COVID-19
confirmed by RT-PCR, aged over 18 years and without any underlying respiratory
disease, with adequate cognitive status defined through the Mini Mental State
Examination and reduced muscle strength respiratory, defined through the assessment
of the maximum inspiratory pressure.
Exclusion Criteria:
- subjects who present any condition that makes it impossible to carry out the
assessments and protocols, complications that justify the interruption of data
collection, such as syncope, severe chest pain, coughing up blood, those who request
withdrawal from the study and who present adverse effects such as hospitalization by
exacerbation of the clinical picture.
Federal University of Rio Grande do Norte
Natal, Rio Grande Do Norte, Brazil
Gabriely Azevêdo
Natal, Rio Grande Do Norte, Brazil
Patrícia Investigador principal
+55 84 33422000
idpa02@hotmail.com
Patrícia Angélica de Miranda Silva Nogueira., Principal Investigator
Universidade Federal do Rio Grande do Norte