EFFECTS OF INSPIRATORY MUSCLE TRAINING IN POST-COVID-19 PATIENTS - Trial NCT05493410

Timeline & Enrollment

Primary Outcome

MIP assessment

Summary

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus, which had its first case
 identified in December 2019 in Wuhan, China. The disease can cause death and collapse in
 health systems, in addition to increasingly prevalent sequelae. Among the persistent symptoms
 presented by patients in the post-COVID-19 phase, we highlight the respiratory ones. The
 diaphragm - the main muscle of respiration - can also undergo structural and functional
 changes resulting from SARS-CoV-2 infection. This finding is related to some respiratory
 sequelae of the disease, such as severe myopathy of the diaphragm with weakness and decreased
 endurance of the inspiratory muscles, dyspnea, fatigue, and failure in ventilatory weaning.
 Considering that COVID-19 can affect the respiratory muscles of afflicted individuals, it is
 reasonable to assume that inspiratory muscle training should improve inspiratory muscle
 weakness and endurance, and the functional capacity of individuals who had symptomatic
 COVID-19. Objective: To evaluate the effect of inspiratory muscle training on inspiratory
 muscle strength and endurance and on the functional capacity of individuals afflicted by
 COVID-19. Methods: This controlled and randomized clinical trial will be conducted according
 to the guidelines of the Vila Velha University Ethics Committee (CEP-UVV). The sample will
 consist of individuals with a positive diagnosis for SARS-CoV-2 infection assessed by means
 of the reverse transcriptase reaction followed by the polymerase chain reaction (RT-PCR) and
 who have already undergone the period of active infection. These individuals will be invited
 to participate in the study as soon as they are evaluated by the cardiopulmonary
 rehabilitation service. Those who meet all the inclusion criteria, agree to participate, and
 sign the free and informed consent form (FICF), will be randomly assigned to two groups, the
 control group (CG, n = 21) and the treatment group (TG, n = 21). The initial evaluation will
 consist of anamnesis, measurement of indirect blood pressure, heart rate, and peripheral
 oxygen saturation by portable pulse oximeter, analysis of maximum inspiratory pressure (MIP),
 dynamic inspiratory muscle strength index (S-Index), and endurance of the inspiratory muscles
 - which will be collected using a digital training device (PowerBreathe KH2), in addition to
 functional assessment through the 1-minute sit-to-stand test. The reassessment will take
 place six weeks after the start of the program and the same data will be collected at the
 participants' homes. Both groups will undergo the rehabilitation protocol, consisting of
 muscle strengthening and aerobic training, with individual assessment of exercise intensity.
 The treated group will undergo inspiratory muscle training through linear pressure load,
 using the POWERbreathe Classic Medic® device to perform two sets of 30 repetitions daily for
 six weeks. The same physical therapist will oversee the training sessions of all patients.
 Statistical analysis: Data normality will be tested using the Shapiro-Wilk test. To analyze
 the differences between groups, we will use the t-test for parametric data and the Wilcoxon
 test for non-parametric data. The level of significance will be set at 5% (p 0.05). Data
 will be analyzed using the SPSS 8.0 software and the results expressed as mean ± standard
 deviation or median and interquartile range.

ICD-10 Classifications