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

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.

Conditions

• Covid19

Interventions

OTHER

TREATMENT GROUP (TG)

In addition to muscle strengthening and aerobic exercise, patients from the TG will undergo IMT for six weeks, performing two sets of 30 repetitions daily using the device POWERbreathe classic medic® (POWERbreathe International Ltd., Southam, United Kingdom). MIP will be measured in all patients before the intervention as described earlier, and patients will exercise at 40% MIP in the first week and 60% MIP in the subsequent five weeks. The patients will be instructed to inhale using the diaphragm muscle, trying to expand the rib cage to avoid using accessory muscles A nose clip will be used to ensure patients breathe exclusively through the training device.

OTHER

CONTROL GROUP (CG)

For six weeks the CG will perform muscle strengthening through a sit and stand up from a chair routine, abduction of upper and lower limbs, and rowing; three sets of 10 repetitions of each exercise will be performed. Elastic tubes will be used, with elasticity defined by color and indicating the greatest resistance the participant can endure with an effort between 4 and 8 on the OMNI-RES scale for perceived exertion. In addition, aerobic exercise will be performed, through walking on flat terrain for five minutes in the first week, 10 minutes in the second week, and 20 minutes in the subsequent week, with intensity between 40-60% of the reserve heart rate and respecting the patients' symptoms. Aerobic training intensity will be calculated by the modified BORG exertion scale maintaining a score between 6 and 7 - with the progression respecting the patients' symptoms - and by the reserve heart rate.

Sponsors & Collaborators

• University Vila Velha

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-30

Primary Completion

2021-12-15

Completion

2022-07-25

Countries

• Brazil

Study Locations