Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05282199
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2022-03-07
Brief Title:
Inspiratory Muscle Training in Post COVID-19 Infection Subjects
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
Efficacy of Inspiratory Muscle Training IMT on Sleep Quality Exercise Tolerance and Pulmonary Radioaerosol Deposition Pattern in Post COVID-19 Infection Subjects
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 ATSERS 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 15s 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 andor muscle pain the presence of a suffering face andor 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 ventilationperfusion disorders
It is important to emphasize that pulmonary scintigraphy is a routine examination in the follow-up of patients with ventilationperfusion disorders Technetium-99m-labeled diethylnotriaminopentaacetic acid Tc 99m and DTPA at an activity of 1 millicuri in 09 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 ACT 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 airwayface 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 powerbreathClassicLight device
The patient will be instructed to perform the training seated with knees and ankles flexed at 90ยบ 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
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 andor muscle pain the presence of a suffering face andor 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 ventilationperfusion disorders
It is important to emphasize that pulmonary scintigraphy is a routine examination in the follow-up of patients with ventilationperfusion disorders Technetium-99m-labeled diethylnotriaminopentaacetic acid Tc 99m and DTPA at an activity of 1 millicuri in 09 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 ACT 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 airwayface 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 powerbreathClassicLight device
The patient will be instructed to perform the training seated with knees and ankles flexed at 90ยบ 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None