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IRCT20201012049010N2 IRCT 2022-03-04 Shahid Beheshti University of Medical Sciences Efficacy and Safety of Respiratory Exercises with Incentive Spirometry in Hospitalized Adult Patients with SARS-CoV-2 Comparison of the effect of the integrated drug- incentive spirometry therapy with drug therapy alone on recovery and mortality of patients admitted to hospital with Covid 19 2021-08-16 anticipated 160 Complete https://irct.ir/trial/60688 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method in this study was based on Simple randomization (random numbers table). To create a random list in Excel software, 160 samples (two identical groups of 80) were considered in one column, then the RAND function was assigned. In the end, the samples were sorted from low to high. On a daily basis, eligible patients were assigned by the registrants based on the embedded list in two groups: A) control and B) intervention. Registrants, outcome assessors, and the relevant health care team were not aware of the randomization process, Blinding description: Eligible patients were divided into two groups by a two-person group of researchers based on a designed table. For one of the patients, a data collection form with a special code will be determined at the time of enrollment. The data were collected by a separate team of collectors on a daily basis and recorded in a designed online data sheet. Health care providers and the treatment team were also unaware of the allocation of patients to either group. The collected data will be statistically analyzed by the analysis group in groups A and B without group-specific labels. 3 Covid19. Intervention 1: Intervention group: Patients in this group (from the day of admission to the study) were given the same in addition to pharmacological and non-pharmacological treatments. After each training session, the patients in the intervention group were asked to intervene after a deep breath for 2 to 5 seconds and confinement. Breathe for 1 second, begin to exhale deeply in the spirometer, encourage each time they can take action, then wait for rest until the patient feels the need, then repeat this breathing exercise 4 more times with the same quality. Will repeat. If the patient receives oxygen through the mouth mask, he or she will receive oxygen through the nasal mask during breathing exercises. This group was also asked to continue the same treatment for the given exercise in case of discharge from the hospital for up to 3 months. Intervention 2: Control group: Patients in this group did not receive any additional intervention and received the same drug and non-drug treatments as the intervention group, based on the opinion of the relevant treatment team according to the latest published version of the national protocol. Yes - There is a plan to make this available What will be shared: All collected data can be subscribed in CSV format after identifying the participants. And videos taken from patients during breathing exercises can also be shared if they are satisfied. When: Immediately after publishing the article To whom: All researchers and individuals working in academic and scientific institutions Conditions: For all scientific and therapeutic uses Where to obtain: Email the corresponding author and the first author of the relevant article How to obtain: After receiving the email, the request will be answered in coordination with the responsible team, and mentioning the source is mandatory Comments:
public Mohammad Bargahi
No-16, Mohammadi 12 meter َAlley, Mirmalek St, Farhang Blv, Saadat Abad, Tehan
Tehran Iran (Islamic Republic of) ۱۳۴۳۹۶۳۷۸۵ +98 21 8868 3799 mmd.bargahi@gmail.com Shahid Beheshti University of Medical Sciences scientific Mostafa Alavi Moghadam
Imam Hussain hosp, Shahid Maddani St, Tehran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 mostafaalavimoghaddam@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Older age equals 18 years Patients with Covid 19 (based on diagnostic methods of the latest published version of the National Protocol) Need to be admitted to a non-intensive care unit Hospitalization in the last 6 hours 18 years no limit Both Any case of CNS disorder that interferes with patient communication and educability Need to be admitted to the intensive care unit at the time of enrollment history of lung disease sPo2<94% (at room air) Participation in any other clinical trial of an experimental treatment for COVID-19 pregnant woman or man who his spouse is pregnant history of CHF Requiring mechanical ventilation at screening Evidence of multi-organ failure Recent of ACS no willingness for enrollment U07.1 + J1 مواردتائید شده کووید 19 با بیماری تنفسی (پنومونی ویروسی) و/یا علایم و نشاته های بیماری تنفسی(تنگی نفس ، سرفه) Treatment - Devices N/A Intervention group: Patients in this group (from the day of admission to the study) were given the same in addition to pharmacological and non-pharmacological treatments. After each training session, the patients in the intervention group were asked to intervene after a deep breath for 2 to 5 seconds and confinement. Breathe for 1 second, begin to exhale deeply in the spirometer, encourage each time they can take action, then wait for rest until the patient feels the need, then repeat this breathing exercise 4 more times with the same quality. Will repeat. If the patient receives oxygen through the mouth mask, he or she will receive oxygen through the nasal mask during breathing exercises. This group was also asked to continue the same treatment for the given exercise in case of discharge from the hospital for up to 3 months. Control group: Patients in this group did not receive any additional intervention and received the same drug and non-drug treatments as the intervention group, based on the opinion of the relevant treatment team according to the latest published version of the national protocol. Clinical recovery rate. Timepoint: Daily until discharge from the hospital. Method of measurement: No shortness of breath (by patients) + Larger SpO2 equal to 93 (no oxygen uptake) + lower temperature equal to 37.5 ° C for 48 hours. Respiratory rate. Timepoint: The first day before the intervention and daily for 5 days or until discharge, whichever is earlier. Method of measurement: Number of breaths per 1 minute. Peripheral blood oxygen saturation in oxygen therapy. Timepoint: The first day before the intervention and daily for 5 days or discharge, whichever is earlier. Method of measurement: Percentage of oxygen after 2 minutes with finger pulse oximeter in 5 minutes apart from oxygen while sitting on the bed. Percentage of peripheral blood oxygen saturation in the absence of oxygen therapy. Timepoint: The first day before the intervention and daily for 5 days or discharge, whichever is earlier. Method of measurement: Percentage of oxygen after 2 minutes with a finger pulse oximeter while sitting on the bed. Intravenous carbon dioxide content. Timepoint: The first day of hospitalization and the fifth day or time of discharge, whichever is earlier. Method of measurement: According to the VBG report. Intravenous oxygen level. Timepoint: The first day of hospitalization and the fifth day or time of discharge, whichever is earlier. Method of measurement: According to the VBG report. Intravenous bicarbonate. Timepoint: The first day of hospitalization and the fifth day or time of discharge, whichever is earlier. Method of measurement: According to the VBG report. Intravenous blood pH. Timepoint: The first day of hospitalization and the fifth day or time of discharge, whichever is earlier. Method of measurement: According to the VBG report. Severity of dyspnea. Timepoint: The first day before the intervention and daily for 5 days or discharge, whichever is earlier. Method of measurement: Based on Modified Borg Standard Questionnaire 0-10 scale (MBS). Blood pressure. Timepoint: The first day before the intervention and daily for 5 days or discharge, whichever is earlier. Method of measurement: With the same standard sphygmomanometer cuff while the patient is sitting on the bed for 10 minutes. Sex. Timepoint: the first day. Method of measurement: Being male or female. Stress level. Timepoint: The first day before the intervention and daily for 5 days or discharge, whichever is earlier. Method of measurement: Based on the standard Zung Self-Rating Anxiety Scale (SAS). Duration of hospitalization. Timepoint: From the first day of hospitalization until discharge. Method of measurement: Number of days elapsed until discharge. One-month mortality rate for any reason. Timepoint: One month after enrollment. Method of measurement: telephone follow-up. 3-month mortality rate for any reason. Timepoint: 3 months after enrollment. Method of measurement: telephone follow-up. The need for intubation. Timepoint: Until discharge from the hospital. Method of measurement: Number of intubated patients based on the opinion of the relevant treatment team. The need for hospitalization in the intensive care unit. Timepoint: Until discharge from the hospital. Method of measurement: Number of patients admitted to the intensive care unit based on the opinion of the relevant treatment team. Maximum exhaled exhaust air pressure in the first second. Timepoint: 3 months after the time of enrollment. Method of measurement: According to spirometry reports. Maximum amount of exhaust air. Timepoint: 3 months after the time of enrollment. Method of measurement: According to spirometry reports. Ratio of exhaust air loss from the first second to the total. Timepoint: 3 months after the time of enrollment. Method of measurement: According to spirometry reports. Overall carbon monoxide emission capacity. Timepoint: 3 months after the time of enrollment. Method of measurement: According to spirometry reports. Mileage in 3 minutes. Timepoint: 3 months after the time of enrollment. Method of measurement: Based on standard 3-minute walk distance test (6MWD). Shahid Beheshti University of Medical Sciences Approved 2021-10-31 Research Ethics Committee of Shahid Beheshti University of Medical Sciences Imam Hussein Hosp, Shahid Madani St, Teharan Tehran Tehran Iran (Islamic Republic of)