Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients.

NCT06362499 | Recruiting

• 1 other identifier: 01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment. In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Ventilation variability and ventilation efficiency

  For the ventilatory variables, the slope and intercept of the VE/VCO2 relationship will be obtained by simple linear regression of the type: VE = a \* V´CO2 +/- b, with "a" corresponding to the slope of the relationship and "b" the interception value, including data from the peak loading exercise (RAMOS et al., 2013). We will also evaluate two new ventilation parameters, the constant rate of CO2 output (CO2CR) and the ventilation efficiency (ηVE). The two new variables were recently described (MULLER; SARAIVA et al., 2021). Briefly, the CO2CR will be obtained in a similar way to that described for the oxygen consumption efficiency curve, that is, taking the 10th base logarithm of VE on the x-axis against VCO2 on the y-axis. This relationship results in a characteristic quadratic function in most cases. The parameter "b" of the linear part of the equation type VCO2 = a \* VE + b \* V´E + c is called CO2CR.

  before and after 6 weeks

Secondary Outcomes (6)

• Respiratory muscle strength

  before and after 6 weeks

• Pulmonary function

  before and after 6 weeks

• Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36)

  before and after 6 weeks

• Peripheral muscle strength

  before and after 6 weeks

• Functional capacity

  before and after 6 weeks

Study Arms (2)

Experimental Group (GE)

EXPERIMENTAL

TMI with 30% of Pimax. with a weekly load increase of 10% of the Pimax value initial. The sessions will consist of 30 repetitions, 4 times a day, 2 sets in the morning and two sets in the afternoon, with a one-minute break between sets, 7 consecutive days a week, for 6 weeks. Individuals will be instructed to perform a rapid contraction of the inspiratory muscles and sustain it for 2 seconds, in each maneuver, and will have the possibility to rest after every 3 repetitions of the IMT, for 30 seconds, to avoid muscle fatigue or any other complications.

Device: Experimental Group

Sham Group (SG)

PLACEBO COMPARATOR

: Individuals will use a TMI device without any charge and will receive the same instructions as in G1. At the end of the research, the control group will be entitled to experimental treatment with the IMT protocol, if it proves to be effective.

Device: Experimental Group

Interventions

Experimental Group DEVICE

After the initial assessment, all volunteers will receive a POWERbreathe® classic light resistance device (POWERbreathe®, Nsc, Brazil), to carry out the training, and will be individually guided on how to use it and how to complete the protocol. They will perform a trial session to familiarize themselves with the device that will not be considered for analysis. Every week, volunteers will receive a telephone call from researcher 2, who will not participate in the evaluation, to confirm whether the exercise with the POWERbreathe® will be performed appropriately at the recommended frequency, intensity, and duration and whether there are any questions regarding the protocol. At the end of each week, participants will receive a video call from researcher 2 to adjust the device according to G1's weekly load progression.

Experimental Group (GE); Sham Group (SG)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects of both sexes will be included, with a diagnosis of COVID-19 confirmed by RT-PCR, aged over 18 years, without any underlying respiratory or cardiac disease and reduced respiratory muscle strength (≤100 cmH2O). Reduced inspiratory muscle strength will be defined using MIP.

You may not qualify if:

• Patients with conditions impairing assessments, health complications that justify interrupting data collection (e.g., syncope, intense chest pain, or cough with blood-tinged sputum), hospitalized due to exacerbation of clinical conditions, or requested to leave the study will be excluded.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (2)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59082-100, Brazil

RECRUITING

Patrícia Nogueira

Natal, Rio Grande do Norte, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Patrícia Nogueira

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrícia Nogueira, Principal

CONTACT

+55 84 33422000; idpa02@hotmail.com

Gabriely Azevêdo, Secondary

CONTACT

+5584999390004; gabrielyazevedo.ga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 12, 2024
• Study Start: April 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)