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

Javaherian, M.; Shadmehr, A.; Keshtkar, A.; Beigmohammadi, M. T.; Dabbaghipour, N.; Syed, A.; Attarbashi Moghaddam, B.

Background: Pulmonary physiotherapy (PPT) is an important therapeutic tool 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. Methods: In 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). Findings: In April 2020, 40 participants were randomly assigned to PPT or basic care groups. At the end of intervention, pO2mortality rates wererence to baseline measure (AMD) 6-43mmHg [95%CI 2-8,10-07],P<0.0001), pCO2(AMD -2-1mmHg [95%CI-6-36,2-21],P=0.0011), Spo2(AMD 4-43% [95%CI 2-04,6-83],P=0.0011), and 3MTW (AMD 91-44m [95%CI 68-88,113-99],P<0.0001) were different between groups. While the mortality rate was not different at one month, at three months it was 25% lower in the PPT group (P=.05). This result needs to be reviewed overall though within the manuscript as it is also reported as insignificant "after considering baseline Spo2 as a covariate: OR=.16 [.26,1.05], P=.07;table 4). There were no significant difference in all SF-36 domains scores between groups after one and three months except body pain domain which was higher in PPT group than basic group significantly(P=.01). No serious adverse event was observed during PPT sessions. Conclusion: Early PPT can be considered as a safe and effective therapeutic choice for patients with severe COVID-19. Clinical Trial Registration ID #NCT04357340.