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Inspiratory Muscle Training in COVID-19 patients after hospital discharge

Inspiratory Muscle Training in COVID-19 patients after hospital discharge

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-10xczgfz
Enrollment
Unknown
Registered
2021-07-12
Start date
2020-10-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle weakness

Interventions

All patients have their respiratory muscle function routinely assessed at post COVID-19 clinic - Hospital São Paulo - UNIFESP. 30 patients with inspiratory muscle weakness (PImax 80% of predicted) wil

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: COVID-19 confirmed; 30 days after hospital discharge

Exclusion criteria

Exclusion criteria: Smoking; Individuals in clinical deterioration; Signs of respiratory instability or severe dyspnoea at rest; use of supplemental oxygen; limitation in lower limbs; participation in a concomitant pulmonary rehabilitation program.

Design outcomes

Primary

MeasureTime frame
To assess the exercise tolerance time, the constant load cardiopulmonary exercise test (CPET) will be used, at 70% of the peak value obtained in incremental CPET, allowing to reach a steady state of the cardiorespiratory and metabolic responses, and to assess exercise tolerance . The percentage of load can be adjusted to induce exercise time within 3-8 min. This test will analyze time limit tolerated, in which it is expected to find a minimum significant difference between groups, with an increase in time tolerated after training of 100 seconds or a difference of 33% compared to the beginning of training. Respiratory and peripheral muscle oxygenation will also be analyzed by the method of near infrared spectroscopy, as well as non-invasive hemodynamic monitoring using transthoracic electrical cardioimpedance.

Secondary

MeasureTime frame
The 6-minute walk test will be performed to evaluate the longest distance walked in 6 minutes, in a hospital environment, with a distance of 30 meters length. Before and after the test, patients will be evaluated for heart rate, blood pressure, pulse oxygen saturation and perception of respiratory effort and lower limbs effort. There is no well-established percentage of clinically significant increase in literature review for these adopted parameters for this condition.;Respiratory muscle function will be evaluated using the following parameters: static inspiratory muscle strength (MIP - Maximum Inspiratory Pressure and MEP - Maximum Expiratory Pressure), dynamic (Sindex), sustained maximum inspiratory pressure (SMIP) and inspiratory muscle endurance test. To assess MIP, Sindex and SMIP, the POWERBreathe® KH2 digital device will be used, conected to BREATHELINK® software, starting from residual lung volume, measured for at least 5 times, with an interval of 1 minute between measurements, maintaining maximum effort for 1 second. The symptom-limited inspiratory resistance test will also be performed by the same device, with a fixed resistive load of 60% of the MIP, which consists of performing successive forced inspirations up to tolerated time. MIP will be measured using an analog manovacuometer, performed from total lung capacity, after maximal inspiration. There is no well-established percentage of clinically significant increase in literature review for these adopted parameters.;To assess quality of life, the SF-36 questionnaire (Short-Form Health Survey) will be used. The evaluation of the results will be done by assigning scores to each question, transformed into a scale from zero to 100, where zero corresponds to a worse quality of life and 100 to a better quality of life. Each dimension will be analyzed separately. There is no well-established percentage of clinically significant increase in literature review for these adopted parameters for this condition

Countries

Brazil

Contacts

Public ContactPriscila Sperandio
prissperandio@gmail.com+55 11 99541-0394

Outcome results

None listed

Source: REBEC (via WHO ICTRP)