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COVID-19NCT05282199

Inspiratory Muscle Training in Post COVID-19 Infection Subjects

A study testing INSPIRATORY MUSCLE TRAINING in people with COVID-19, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Long-term COVID has been considered a clinical condition in which the patient, after the critical period of the disease, still has systemic symptoms such as muscle weakness, inability to exercise, sleep disorders and it is still unknown what happens to the pulmonary deposition process. of aerosols. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19
What is being tested?
INSPIRATORY MUSCLE TRAINING
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteBrazil
Study dates
1 Mar 2022to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of all genders, over 18 years of age, who are not undergoing any type of post-infection treatment, with a diagnosis through RT-PCR positive for the Coronavirus, who fall within the period of up to 10 days after hospital discharge will be included. .

Who cannot join

  • Individuals with previous orthopedic, neurological problems or any cardiovascular or respiratory disease in their clinical history, pregnant women and patients in the active phase of infection for the coronavirus, or who cannot maintain proper positioning during the scintigraphy exam will be excluded pulmonary

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Universidade Federal de Pernambuco

    Recife, Pernambuco

Other trials in Brazil

About this study

Official title: Efficacy of Inspiratory Muscle Training (IMT) on Sleep Quality, Exercise Tolerance and Pulmonary Radioaerosol Deposition Pattern in Post COVID-19 Infection Subjects

Long-term COVID has been considered a clinical condition in which the patient, after the critical period of the disease, still has systemic symptoms such as muscle weakness, inability to exercise, sleep disorders and it is still unknown what happens to the pulmonary deposition process. of aerosols. In clinical practice, inspiratory muscle training has been used to treat these patients, but the effectiveness of this intervention in reducing these symptoms is still considered a gap in the literature. To evaluate the effectiveness of inspiratory muscle training in individuals who were affected by COVID-19 to improve submaximal aerobic capacity, respiratory muscle strength, sleep quality, pulmonary deposition of the inhaled radiopharmaceutical and quality of life. This is a quasi-experimental study. , in which elderly volunteers over 18 years of both sexes residing in the city of Recife-Pernambuco will participate. The sample will consist of individuals who have been affected by COVID-19, whose severity of the disease will be classified according to the criteria established by the study by Parasher (2020). 6 minutes. The pulmonary deposition of the radiopharmaceutical will be evaluated pulmonary function will be evaluated by scintigraphy while the maximum respiratory pressures will be evaluated by a manovacuometer. Subjective sleep assessment will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Daytime Sleepiness Scale (ESS) and objective measurement by actigraphy. Finally, quality of life will be measured by the generic Medical OutcomesStudy 36-Item Short-Form HealthSurvey (SF-36) questionnaire. In the group of post-COVID patients in which the reduction in endurance and inspiratory muscle power are identified, an inspiratory muscle training (IMT) will be performed with a load equivalent to 50% of the MIP (assessed weekly), for eight weeks.

Read the detailed description

The pulmonary function test will be used for the inclusion criteria and characterization of the sample. The Medical Microloop spirometer will be used. The test will be performed at least three times, respecting an interval of at least one minute between maneuvers, until the device considers the best maneuver as reproducible and acceptable. Subjects will perform manovacuometry before and weekly until completing 8 weeks of IMT. The present study will follow the recommendations proposed by the ThoracicSociety/ EuropeanRespiratorySociety (ATS/ERS) and the Brazilian Society of Pneumology and Tisiology (SBPC), thus, during the collection of the values referring to MIP, the patient will be seated, with free arms and will be guided by the person responsible for carrying out the test to attach a mouthpiece (divers type) with a leak orifice of 2mm of internal diameter to his mouth, the individual will be instructed to maintain an inspiratory and expiratory pressure for at least 1.5s so that it can be observed the maximum sustained pressure for one second (maximum mean pressure) in the manovacuometer (MVD 300, Globalmed, Brazil), used in the Cardiopulmonary Laboratory of the Department of Physiotherapy of the Federal University of Pernambuco. The measures with the highest value presented will be used (with variation less than or equal to 10% among the others).

The evaluation of measures of inspiratory muscle performance will be performed before and after the 8 weeks of training. The Test of Incremental Respiratory Endurance (TIRE) provides a more comprehensive assessment of inspiratory musculature by measuring not only strength, but also endurance and work capacity in a single session. The TIRE includes measurements of MIP (MIP), Maximum Sustained Inspiratory Pressure (SMIP) and Inspiratory Duration (DI). A single assessment session will consist of 3-5 sequential trials with 60 second rest intervals between efforts. The highest SMIP will be used to identify the best of the repeated attempts within the session, providing the MIP and SMIP values to be documented and used for study purposes. All inspiratory maneuvers will be performed with subjects seated in a chair and using nose clips in accordance with American ThoracicSociety (ATS) standards for respiratory muscle testing. For the objective assessment of objective sleep parameters, actigraphy will be used, which is a method of objective assessment of the sleep-wake cycle and motor activity, based on limb movements for 24 hours. An actigraph (Fitbit) will be placed on the non-dominant wrist (like a wristwatch) to perform movement detection. Data will be collected for 7 consecutive days and, during this period, participants will sleep at home and be asked to adhere to their normal daily activities and sleep-wake schedules. The ESS will be applied before and after the 8 weeks of inspiratory muscle training. It is a scale containing eight daily situations requesting a self-assessment of the individual about the chance of dozing in the execution of these activities, scoring from 0 to 3, where 0: no chance of dozing, 1: small chance, 2: moderate chance, 3: high chance. When the sum of the scale components reaches a value ≥10, it means that the patient has excessive daytime sleepiness that needs to be investigated. The PSQI will be applied before and after the 8 weeks of inspiratory muscle training. It consists of a self-assessment questionnaire, which investigates sleep quality and disturbances over a period of 1 month. It consists of nineteen individual items that give rise to seven scoring "components": subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The SF36 will be applied before and after the 8 weeks of inspiratory muscle training. It consists of a generic instrument for assessing quality of life, which is easy to administer and understand.

The 6MWT will be performed before and after 8 weeks of inspiratory muscle training. Patients will be instructed to walk as quickly as possible in an open and linear corridor of 30m in length, signposted meter by meter. During the walk test, patients will have their SpO2 and HR monitored using a transcutaneous pulse oximeter. The tests will be interrupted if there are symptoms of dyspnea and/or muscle pain, the presence of a suffering face and/or a drop in SpO2 ≤ 88%, with a time counting up to six minutes. It is important to emphasize that pulmonary scintigraphy is a routine examination in the follow-up of patients with ventilation/perfusion disorders.

It is important to emphasize that pulmonary scintigraphy is a routine examination in the follow-up of patients with ventilation/perfusion disorders. Technetium-99m-labeled diethylnotriaminopentaacetic acid (Tc 99m and DTPA) at an activity of 1 millicuri in 0.9% saline for a total volume of 3 ml will be inhaled. For inhalation, an orofacial mask or mouthpiece (Vital signs, West SuSex, UK) fitted with one-way valves and with an inspiratory limb connected to a radioisotope nebulizer (Ventis® II Medical Device, Class II, CE 0459, Ventibox / CIS BioInternational, France) will be used. used.

The inhalation of the radioaerosol will be performed with the individual in a sitting position for the time necessary for the solution to be completed. Subjects will be previously instructed to breathe slowly and deeply through the mouth, performing an inspiratory pause for 3s with each breath. After inhalation, participants will be instructed to rinse their mouths and drink water to clear the throat and esophagus of radioaerosol deposited in these regions. Scintigraphy will be performed before and after the 8 weeks of training. Volunteers will undergo examinations at the Advanced Nuclear Medicine Diagnostic Imaging Clinic with a Nuclear Medicine Specialist. Upon completion of aerosol inhalation, volunteers will be seated in front of the gamma camera (STARCAM 3200 AC/T GE MEDICAL SYSTEMS - UK ) for image acquisition of the posterior thorax for a period of 300 seconds with a matrix of 256 x 256 pixels. After the first image, the collimator will be repositioned to acquire the upper airway/face images. To determine the inhaled mass, the sum of the numbers of counts present in each compartment will be evaluated.

For image analysis, pulmonary and extrapulmonary regions of interest (ROI) will be delimited using the Xeleris 3 Functional Workstation Image software (GE Healthcare, Milwaukee, USA).

Subjects will perform training with moderate load at 50% of MIP. The training will be carried out using the powerbreath®ClassicLight device.

The patient will be instructed to perform the training seated, with knees and ankles flexed at 90º, feet flat on the floor, with one hand holding the device and the other resting on the leg. The nose clip will be placed and the individuals will perform three cycles of 30 respiratory incursions in an explosive way, respecting the one-minute interval between the series. The training will be performed by the patient at home, independently, twice a day, seven days a week, for eight weeks, noting the frequency and any occurrences during the training in the training diary that each individual will receive. The adjustment will be carried out weekly in face-to-face meetings (once a week) in the laboratory and patient monitoring will also be carried out via telephone, through calls made by the responsible researcher.

Conditions
COVID-19
Being tested
INSPIRATORY MUSCLE TRAINING
Keywords
COVID-19, Inspiratory muscle training, scintigraphy, radioaerosol distribution, inhalation therapy
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSPIRATORY MUSCLE TRAININGOther

    Also called Powerbreath® ClassicLight

    In the group of post-COVID-19 patients in which reduced endurance and inspiratory muscle power are identified, inspiratory muscle training (IMT) will be performed with a load equivalent to 50% of MIP (assessed weekly) for eight weeks.

Study groups in NCT05282199
Study groupRoleWhat they receive
IMT groupExperimentalIn the group of post-COVID patients in which reduced endurance and inspiratory muscle power are identified, inspiratory muscle training (IMT) will be performed with a load equivalent to 50% of MIP (assessed weekly) for eight weeks.
Receives: Other: INSPIRATORY MUSCLE TRAINING

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radioaerosol Pulmonary Deposition

    Amount of radiodrug deposited in the lungs after inhalation

    Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282199
Sponsor's protocol ID
IMT and COVID-19
Status last verified
Jul 2025
First submitted
7 Mar 2022
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not

Questions about this trial

What is this clinical trial studying?

A study testing INSPIRATORY MUSCLE TRAINING in people with COVID-19, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radioaerosol Pulmonary Deposition (time frame: 3 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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