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

Long-term COVID has been considered a clinical condition in which the patient, after thecritical 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 thepulmonary deposition process. of aerosols. In clinical practice, inspiratory muscletraining has been used to treat these patients, but the effectiveness of thisintervention in reducing these symptoms is still considered a gap in the literature. Toevaluate the effectiveness of inspiratory muscle training in individuals who wereaffected by COVID-19 to improve submaximal aerobic capacity, respiratory muscle strength,sleep quality, pulmonary deposition of the inhaled radiopharmaceutical and quality oflife. This is a quasi-experimental study. , in which elderly volunteers over 18 years ofboth sexes residing in the city of Recife-Pernambuco will participate. The sample willconsist of individuals who have been affected by COVID-19, whose severity of the diseasewill be classified according to the criteria established by the study by Parasher (2020).6 minutes. The pulmonary deposition of the radiopharmaceutical will be evaluatedpulmonary function will be evaluated by scintigraphy while the maximum respiratorypressures will be evaluated by a manovacuometer. Subjective sleep assessment will beassessed using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth DaytimeSleepiness Scale (ESS) and objective measurement by actigraphy. Finally, quality of lifewill 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 inendurance 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), foreight weeks.

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.

Recruiting
COVID-19

Other: INSPIRATORY MUSCLE TRAINING

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.
Other Name: Powerbreath® ClassicLight

Eligibility Criteria

Inclusion Criteria:

- 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. .

Exclusion Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Brazil
Locations

Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil

Investigator: JOSE CARLOS N NOBREGA JUNIOR
Contact: (81) 99559-5803
c10carlo@gmail.com

Contacts

JOSE CARLOS N NOBREGA JUNIOR, M.D.
(81) 99559-5803
c10carlo@gmail.com

ARMELE DORNELAS DE ANDRADE, PhD
(81)98781-8965
armeledornelas@yahoo.com

ARMELE DORNELAS DE ANDRADE, PhD, Principal Investigator
Universidade Federal de Pernambuco

Universidade Federal de Pernambuco
NCT Number
Keywords
Covid-19
inspiratory muscle training
scintigraphy
radioaerosol distribution
inhalation therapy
MeSH Terms
COVID-19
Respiratory Aspiration