Rehabilitation in Survivors of COVID-19 (RE2SCUE): a nonrandomized, controlled, and open protocol

  1. Maria Cristine Campos
  2. Tatyana Nery
  3. Ana Cristina de Bem Alves
  4. Ana Elisa Speck
  5. Danielle Soares Rocha Vieira
  6. Ione Jayce Ceola Schneider
  7. Maria Paula Pereira Matos
  8. Livia Arcêncio
  9. Aderbal Silva Aguiar

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Abstract

Objective

This study aimed to evaluate the effects of physical rehabilitation for adults with sequelae after COVID-19.

Methods

This clinical, nonrandomized, controlled, and open study will examine 82 participants who have met the inclusion criteria and who will be divided into treatment and control groups according to participant preference. The intervention group will receive face-to-face care; the control group will receive remote educational guidance for 8 weeks, with pre-post evaluations. The primary outcomes are dyspnea, fatigue, and exercise capacity; the secondary outcomes are lung function, heart rate variability, handgrip strength, knee extensor strength and electrical activity, physical activity, functional limitation, cognitive function, depression and anxiety, and biochemical measures of hypoxia, inflammation, oxidative stress, blood glucose, and lactate blood tests. The survey will follow the Standard Protocol Items for Randomized Trials guidelines, and the results will be reported according to the Consolidated Standards of Reporting Trials guidelines. Effects will be assessed based on the intent-to-treat data collected. Analysis of covariance will be used for the initial and final evaluations, with a significance level of 5%.

Results and Conclusions

The results will show the effectiveness of rehabilitation in adults with post-COVID-19 sequelae.

Impact

Fatigue, dyspnea, cough, and muscle and joint pain are common sequelae of post-COVID-19 syndrome. Physical rehabilitation is one modality for treating these sequelae. This protocol can provide a treatment model for patients with post-COVID-19 sequelae.

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  1. ScreenIT

    SciScore for 10.1101/2021.09.06.21262986: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingThe analysis will be carried out by a researcher blinded to the participants’ allocation through the program Stata SE 16.1 (2020; StataCorp.
    Power AnalysisSample size calculation: The sample size calculation is based on the functional capacity results assessed by the 6-min walking test from the 2020 study by Kai Liu et al.(20).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The analysis will be carried out by a researcher blinded to the participants’ allocation through the program Stata SE 16.1 (2020; StataCorp.
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    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.

  2. Version published to 10.1101/2021.09.06.21262986v1 on medRxiv