Outpatient and Home Pulmonary Rehabilitation Program Post COVID-19: A study protocol for clinical trial
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Abstract
Background
The coronavirus disease 2019 (COVID-19) is a widespread, highly contagious inflammatory process that causes respiratory, physical and psychological dysfunction. COVID-19 mainly affects the respiratory system and evolves in the acute phase from mild cases with common symptoms, such as fever, cough, and fatigue, to the moderate-to-severe form, causing massive alveolar damage resulting in dyspnea and hypoxemia that can rapidly progress to pneumonia, and acute respiratory distress syndrome. The acute form usually causes severe pulmonary sequelae such as pulmonary fibrosis or progression to organ failure, leading to worsening metabolic dysfunction and/or death.
Purpose
To verify the effects of an outpatient and home pulmonary rehabilitation program (PRP) on clinical symptoms, pulmonary function, physical activity level, functional status, autonomic activity, peripheral muscle strength, static and functional balance, functional mobility, anxiety and depression, post-traumatic stress, health-related quality of life, and survival of patients with sequelae from COVID-19.
Methods
This study will be a cohort, parallel, two-arm multicentric study, to be carried out in three clinical centers, with blind evaluation, with 06 weeks of training and follow-up. This study was designed according to the recommendations of the CONSORT statement. To be involved in this clinical study, according to the inclusion criteria, women and men aged between 16 and 75 years affected by COVID-19. The proposed PRP is based on the guidelines recommended by the Global Initiative for Chronic Obstructive Lung Disease and, consists of a combination of aerobic and muscle strengthening exercises, lasting six weeks, with a frequency of three times a week.
Discussion
In patients infected with COVID-19 with persistent symptoms and sequelae, PRP mainly seeks to improve dyspnea, relieve anxiety and depression, prevent, and reduce complications and/or dysfunctions, reduce morbidity and mortality, and improve health-related quality of life.
Trial registration
This study was registered at clinicaltrials.gov (ID: COVID-19 PULMONARY REHAB NCT04982042 ).
Article activity feed
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SciScore for 10.1101/2022.04.08.22273608: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Ethical considerations and consent to participate: All procedures performed with the patients involved in this study were in accordance with the international ethical standards for research involving human.
IRB: The research protocol was approved by the Ethics Committee for Research with Human Beings of Universidade Evangélica de Goiás (UNIEVANGÉLICA) on September 24, 2020, under protocol number 4,235,203.Sex as a biological variable Participants: recruitment and eligibility criteria: To be involved in this clinical study, according to the inclusion criteria, women and men aged between 16 and 75 years affected by COVID-19 will be invited. Randomization not detected. Blinding Study … SciScore for 10.1101/2022.04.08.22273608: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Ethical considerations and consent to participate: All procedures performed with the patients involved in this study were in accordance with the international ethical standards for research involving human.
IRB: The research protocol was approved by the Ethics Committee for Research with Human Beings of Universidade Evangélica de Goiás (UNIEVANGÉLICA) on September 24, 2020, under protocol number 4,235,203.Sex as a biological variable Participants: recruitment and eligibility criteria: To be involved in this clinical study, according to the inclusion criteria, women and men aged between 16 and 75 years affected by COVID-19 will be invited. Randomization not detected. Blinding Study design: This study will be a cohort, parallel, two-arm multicentric study, to be carried out in three clinical centers, with blind transversal and longitudinal evaluation, with 06 weeks of training and follow-up. Power Analysis Sample size and power calculation: The sample size was calculated according to Shahin et al. (2008). Cell Line Authentication Authentication: It is a well-developed, validated, and easy-to-use software for analyzing the behavior of sympathetic and parasympathetic autonomic activities. Table 2: Resources
Software and Algorithms Sentences Resources The original versions were made available in English and were later translated into other languages, including Portuguese [69,70]. Portuguesesuggested: NoneG*Power Statistical Power Analyses for Mac were utilized according to the appropriate reference [109,110]. G*Powersuggested: (G*Power, RRID:SCR_013726)IBM SPSS Statistics for Windows, version 23.0. Armonk, NY: IBM Corp). SPSSsuggested: (SPSS, RRID:SCR_002865)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:We highlight the benefits in terms of reduced fatigue and dyspnea, increased functional and exercise capacity, reduced limitations in ADLs, improved quality of life, mood and motivation, increased adherence to recommended clinical treatments, increased participation in therapy decisions, strengthening the patient’s self-management capacity, and reducing the amount of health care for patients, families, and communities, including reducing the number of hospitalizations and increasing survival, with a consequent reduction in health costs for the state. Potential impact and significance of the study: According to the international scientific literature, which shows excellent results of pulmonary rehabilitation for patients with pulmonary diseases, we expect that, with the participation of patients affected by COVID-19 in outpatient and home pulmonary rehabilitation programs, we will obtain benefits in the short, medium, and long term. The potential clinical impact of this study will be to reduce fatigue and dyspnea, increase functional and exercise capacity, reduce limitations in ADLs, improve quality of life, and consequently reduce morbidity and mortality in patients affected by COVID-19. A reduction in decompensation and hospitalizations is also expected, representing a reduction in health costs by the government. It is hoped that with the results of this clinical trial, we can encourage the scientific community to increase the availability of pulmonary rehabilitation program...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04982042 Recruiting Post COVID-19 Pulmonary Rehabilitation Program 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.
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