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

  1. Mohammad Javaherian
  2. Azadeh Shadmehr
  3. Abbasali Keshtkar
  4. Mohammad Taghi Beigmohammadi
  5. Narges Dabbaghipour
  6. Aabis Syed
  7. Behrouz Attarbashi Moghadam

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

Pulmonary 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.

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-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], P<0.01), Spo2 (AMD 4.43% [95%CI 2.04, 6.83], P = 0.0011), and 3MTW (AMD 91.44 m [95%CI 68.88, 113.99], P<0.01) were higher in PPT group and basic care group, pCO2 was not improved (AMD -2.1 mmHg [95%CI-6.36, 2.21], P = 0.33). Based on the logistic model adjusted to baseline Spo2, the risks of mortality were reduced 81% ([95%CI: 97% reduction to 30% increase], P = .09) and 84% ([95%CI 74% reduction to 5% increase], P = .06) at one-month and three-month, respectively. There were no significant differences in most SF-36 domains scores after one and three months. No serious adverse event was observed during PPT sessions.

Conclusion

Early PPT can be considered a safe and relatively effective therapeutic choice for patients with severe COVID-19.

Article activity feed

  1. Version published to 10.1371/journal.pone.0268428
  2. Version published to 10.1101/2021.04.24.21255892v3 on medRxiv
  3. Version published to 10.1101/2021.04.24.21255892v2 on medRxiv
  4. ScreenIT

    SciScore for 10.1101/2021.04.24.21255892: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: [1]This trial was approved by the Ethical Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1399.205).
    Consent: A signed informed consent form was obtained from all patients after explaining the study details to them.
    Sex as a biological variablenot detected.
    RandomizationStudy design: This was a single-center, single-blind, prospective, two parallel-armed randomised controlled trial (RCT) comparing the efficacy of six sessions PPT + basic care with basic care alone in hospitalized patients with COVID-19 pneumonia.
    Blindingnot detected.
    Power AnalysisAfter assuming a type I error of .01 and 80% power, a sample size of 13 patients per group was calculated to detect a mean difference (MD) of around 4% Spo2 between PPT and basic care groups.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    After one-month follow-up, PPT was associated with higher HRQOL in role limitation due to physical health (NNT≈ 3) with a moderate effect size. Also, patients in PPT group presented higher score in body pain domain of SF-36 instrument than basic care group (NNT≈ 2) after three months with a large effect size. Patients with COVID-19 suffer from significant physical and psychological impairments that impact their HRQOL; Therefore, interventions improving HRQOL like rehabilitation should be considered in their management [26]. Although some limited domains of DF-36 presented higher value in PPT group than control group at one-month and three-month with very small effect size, but higher values of other domains in PPT group than control group makes an idea in the mind that prolonged duration rehabilitation, especially after discharge, may improve physical and psychological impairments and HRQOL. It has been shown that six weeks of respiratory rehabilitation could improve respiratory function, aerobic capacity, HRQOL, and anxiety of elderly patients with COVID-19, as reported by Liu and colleagues [12]. Allocated participants to the PPT group had a 20% and 25% lower one-month and three-month mortality rate than the basic care group, respectively. The NNT analysis shows that PPT kept alive one out of five patients until one month. However, the results of logistic test of one month mortality rate is not statistically significant. Based on the NNT analysis, PPT can keep alive one out...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04357340CompletedThe Effects of Pulmonary Physiotherapy Treatments on Patient…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  5. Version published to 10.1101/2021.04.24.21255892v1 on medRxiv