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

NCT05493410 | Completed DMC

• 1 other identifier: 49725921.6.0000.5064
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

covid19; inspiratory muscle training (IMT); maximum inspiratory pressure (MIP); dynamic inspiratory muscle strength index (S-Index); inspiratory muscle endurance; respiratory physicaltherapy; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• MIP assessment

  This measurement, obtained by means of a digital manovacuometer (POWERbreathe K series KH2®, HaB International, Warwickshire, United Kingdom), reflects the pressure developed by the respiratory muscles plus the elastic recoil pressure of the respiratory system in the residual volume and is an index of global respiratory output rather than a direct measure of the contractile properties of the inspiratory muscles. This result will be used to monitor the influence of IMT on inspiratory muscle strength. The present proposal will predict MIP values through the equation of Neder et al., in which: For men: MIP (cmH2O) = 155,3 - (0,80 x age) For women: MIP (cmH2O) = 110,4 - (0,49 x age)

  6 weeks

Secondary Outcomes (3)

• S-Index assessment

  6 weeks

• Assessment of inspiratory muscle endurance

  6 weeks

• 1-MINUTE SIT-TO-STAND TEST

  6 weeks

Study Arms (2)

TREATMENT GROUP (TG)

EXPERIMENTAL

Pulmonary rehabilitation protocol consisting of muscle strengthening, aerobic training, and IMT using the POWERbreathe Classic Medic® device - será comparado with the CONTROL GROUP (CG), which will not undergo IMT.

Other: TREATMENT GROUP (TG)

CONTROL GROUP (CG)

ACTIVE COMPARATOR

Pulmonary rehabilitation protocol consisting of muscle strengthening and aerobic training.

Other: CONTROL GROUP (CG)

Interventions

TREATMENT GROUP (TG) OTHER

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.

Also known as: inspiratory muscle training using the POWERbreathe Classic Medic® device, muscle strengthening, aerobic training

TREATMENT GROUP (TG)

CONTROL GROUP (CG) OTHER

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.

Also known as: muscle strengthening, aerobic training

CONTROL GROUP (CG)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes diagnosed with COVID-19 by RT-PCR who are not in the transmission window;
• Individuals between 30 and 70 years of age;
• A signed FICF.

You may not qualify if:

• Patients who had previously undergone IMT;
• Inability to perform the assessment tests;
• Orthopedic, visual, and neurological problems that would limit exercise treatment;
• Patients who are unable to undergo IMT because of discomfort with the use of the device;
• Respiratory diseases, severe heart and/or neuromuscular diseases that pre-exist COVID-19;
• Participants who do not have 90% attendance at rehabilitation sessions;
• Patients who required orotracheal intubation and use of mechanical ventilation support;
• Patients with body mass index (BMI) above 40.

Sponsors & Collaborators

• University Vila Velha: lead

Study Sites (2)

Maurício Bona Gracelli

Vila Velha, Espírito Santo, 29101460, Brazil

Location

Maurício Bona Gracelli

Vitória, Espírito Santo, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding in the distribution of participants will be guaranteed, as it will be carried out by a different researcher from the one who will treat the patients. In addition, the researchers who will collect and analyze the data will be different and blind to the experimental groups and types of intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were split into two experimental groups: CONTROL GROUP (CG): Pulmonary rehabilitation protocol comprising muscle strengthening and aerobic training; TREATMENT GROUP (TG): Pulmonary rehabilitation protocol comprising muscle strengthening, aerobic training, and inspiratory muscle training using the POWERbreathe Classic Medic® device.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 30, 2021
• Primary Completion: December 15, 2021
• Study Completion: July 25, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

BR (2)