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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201012049010N2

Enrollment

160

Registered

2022-03-04

Start date

2021-08-16

Completion date

Unknown

Last updated

2022-03-08

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

Conditions

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Interventions

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 tr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. Tim	—

Measure

Time frame

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. Tim

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Bargahi

Shahid Beheshti University of Medical Sciences

mmd.bargahi@gmail.com+98 21 8868 3799

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026