Safety and efficacy of pulmonary physiotherapy in hospitalized patients with severe COVID-19 pneumonia (PPTCOVID study): A prospective, randomised, single-blind, controlled trial.

BackgroundPulmonary physiotherapy (PPT) is an important treatment in the management of patients with different types of pulmonary disorders. We aimed to evaluate safety and efficacy of PPT in hospitalized patients with severe COVID-19 pneumonia.MethodsIn this randomised, single-blind, controlled trial, we enrolled hospitalized, non-intubated patients (18 to 75 years with oxygen saturation (Spo2) in free-air breathing ≤90%) with COVID-19 pneumonia at a referral hospital. Participants were randomly assigned (1:1) to receive PPT (six sessions PPT with breathing exercises and airway clearance techniques) or basic care. The primary outcomes were venous blood O2 (pO2) and CO2 (pCO2) pressures, Spo2, and three-minute walking test (3MWT) that were assessed before and end of sixth session. Secondary outcomes included level of dyspnea, venous blood PH, one-month mortality, three-month mortality and short form-36 (SF-36) after one and three months. The assessor was blinded to the assignment. This trial is registered with ClinicalTrials.gov (NCT04357340).FindingsIn April-May 2020, 40 participants were randomly assigned to PPT or basic care groups. While at the end of intervention, pO2 (adjusted mean difference to baseline measure (AMD) 6.43 mmHg [95%CI 2.8, 10.07], PConclusionEarly PPT can be considered a safe and relatively effective therapeutic choice for patients with severe COVID-19

Study protocol (English version).

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Participant’s data including characteristics and primary outcome measurement.

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Distribution of different outcomes according to two arms in addition to related effect sizes.

Distribution of different outcomes according to two arms in addition to related effect sizes.</p

Study protocol (Farsi version).

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The reason for protocol modifications.

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CONSORT 2010 checklist of information to include when reporting a randomised trial*.

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Trial profile.

* These participants were intubated during three days and therefore did not participate in the assessment after three days. They died before one-month follow-up.</p

Demographics and clinical characteristics of participants.

Demographics and clinical characteristics of participants.</p

The mortality rate of participants allocated to groups in addition to related effect sizes.

The mortality rate of participants allocated to groups in addition to related effect sizes.</p