Assessment of Functional Capacity in Long-COVID

Long COVID Clinical Trial

Official title:

Evaluation of Lung Function, Lung Ultrasound and Functional Capacity in Long-COVID Patients Who Underwent Physical Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05967039
• Other study ID #: 30135320.0.0000.5259
• Status: Active, not recruiting
• Start date: August 8, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Centro Universitário Augusto Motta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. This retrospective observational study aims to compare functional capacity, lung function, and lung ultrasound findings in patients who underwent physical therapy to those who did not.

Description:

Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2 (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale at the beginning of this millennium. Many patients need physical therapy in their recovery process. A paucity of prognostic studies in patients with long-COVID shows the need to identify the main repercussions on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. Objective: The present study aims to compare functional capacity, lung function, and lung ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy to those who did not. Methods: This is a retrospective observational study with quantitative data analysis. The study will be carried out at the Pulmonary Function Laboratory of the Policlínica Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical evaluation will be performed. In the survey, it will be asked whether the patient had undergone physical therapy treatment, so they can be allocated in the control or intervention group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a tool to measure functional status over time after COVID-19. Then, patients will have their lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy). It is expected that understanding the consequences of long-COVID on pulmonary ventilation can help to design therapeutic strategies in rehabilitation services.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization or not, regardless of whether or not they were treated in the ICU. Exclusion Criteria: Patients unable to perform the tests. Patients with musculoskeletal disorders not associated with COVID-19. Patients with lung, heart or cerebrovascular diseases not associated with COVID-19.

Related Conditions & MeSH terms

• Long COVID
• Post-COVID-19 Syndrome

Intervention

Other:
• Physiotherapy
Physiotherapy in respiratory rehabilitation

Locations

Country	Name	City	State
Brazil	Agnaldo José Lopes	Rio de Janeiro
Brazil	Centro Universitario Augusto Motta	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

References & Publications (57)

Ahmad FB, Cisewski JA, Minino A, Anderson RN. Provisional Mortality Data - United States, 2020. MMWR Morb Mortal Wkly Rep. 2021 Apr 9;70(14):519-522. doi: 10.15585/mmwr.mm7014e1. Erratum In: MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):900. — View Citation

Al-Ani F, Chehade S, Lazo-Langner A. Thrombosis risk associated with COVID-19 infection. A scoping review. Thromb Res. 2020 Aug;192:152-160. doi: 10.1016/j.thromres.2020.05.039. Epub 2020 May 27. — View Citation

Albuquerque CG, Andrade FM, Rocha MA, Oliveira AF, Ladosky W, Victor EG, Rizzo JA. Determining respiratory system resistance and reactance by impulse oscillometry in obese individuals. J Bras Pneumol. 2015 Sep-Oct;41(5):422-6. doi: 10.1590/S1806-37132015000004517. — View Citation

American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available. Erratum In: Am J Respir Crit Care Med. 2003 May 15;1451-2. — View Citation

Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nat Med. 2020 Apr;26(4):450-452. doi: 10.1038/s41591-020-0820-9. No abstract available. — View Citation

Bahl P, Doolan C, de Silva C, Chughtai AA, Bourouiba L, MacIntyre CR. Airborne or Droplet Precautions for Health Workers Treating Coronavirus Disease 2019? J Infect Dis. 2022 May 4;225(9):1561-1568. doi: 10.1093/infdis/jiaa189. — View Citation

Bansal M. Cardiovascular disease and COVID-19. Diabetes Metab Syndr. 2020 May-Jun;14(3):247-250. doi: 10.1016/j.dsx.2020.03.013. Epub 2020 Mar 25. — View Citation

Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31. — View Citation

Beraldo GL, Fonseca EKUN, Yokoo P, Matos MJR, Rosa MEE, Silva MMA, Chate RC, Shoji H, Ishikawa WY. Novel coronavirus pneumonia and acute pulmonary thromboembolism: casualty or causality? Einstein (Sao Paulo). 2020 Jun 3;18:eAI5750. doi: 10.31744/einstein_journal/2020AI5750. eCollection 2020. No abstract available. — View Citation

Berger KI, Reibman J, Oppenheimer BW, Vlahos I, Harrison D, Goldring RM. Lessons from the World Trade Center disaster: airway disease presenting as restrictive dysfunction. Chest. 2013 Jul;144(1):249-257. doi: 10.1378/chest.12-1411. — View Citation

Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30. — View Citation

Biryukov J, Boydston JA, Dunning RA, Yeager JJ, Wood S, Ferris A, Miller D, Weaver W, Zeitouni NE, Freeburger D, Dabisch P, Wahl V, Hevey MC, Altamura LA. SARS-CoV-2 is rapidly inactivated at high temperature. Environ Chem Lett. 2021;19(2):1773-1777. doi: 10.1007/s10311-021-01187-x. Epub 2021 Feb 3. — View Citation

Buonsenso D, Sali M, Pata D, De Rose C, Sanguinetti M, Valentini P, Delogu G. Children and COVID-19: Microbiological and immunological insights. Pediatr Pulmonol. 2020 Oct;55(10):2547-2555. doi: 10.1002/ppul.24978. Epub 2020 Jul 30. — View Citation

Butzko RP, Sotolongo AM, Helmer DA, Klein-Adams JC, Osinubi OY, Berman AR, Ortiz-Pacheco R, Falvo MJ. Forced oscillation technique in veterans with preserved spirometry and chronic respiratory symptoms. Respir Physiol Neurobiol. 2019 Feb;260:8-16. doi: 10.1016/j.resp.2018.11.012. Epub 2018 Nov 30. — View Citation

Caglar Tosun BN, Zeren M, Barlik M, Demir E, Gulen F. Investigation of dynamic hyperinflation and its relationship with exercise capacity in children with bronchiectasis. Pediatr Pulmonol. 2022 Sep;57(9):2218-2226. doi: 10.1002/ppul.26028. Epub 2022 Jun 14. — View Citation

Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603. — View Citation

Chan JF, To KK, Tse H, Jin DY, Yuen KY. Interspecies transmission and emergence of novel viruses: lessons from bats and birds. Trends Microbiol. 2013 Oct;21(10):544-55. doi: 10.1016/j.tim.2013.05.005. Epub 2013 Jun 14. — View Citation

Colavita F, Lapa D, Carletti F, Lalle E, Bordi L, Marsella P, Nicastri E, Bevilacqua N, Giancola ML, Corpolongo A, Ippolito G, Capobianchi MR, Castilletti C. SARS-CoV-2 Isolation From Ocular Secretions of a Patient With COVID-19 in Italy With Prolonged Viral RNA Detection. Ann Intern Med. 2020 Aug 4;173(3):242-243. doi: 10.7326/M20-1176. Epub 2020 Apr 17. No abstract available. — View Citation

Costa IBSDS, Bittar CS, Rizk SI, Araujo Filho AE, Santos KAQ, Machado TIV, Andrade FTA, Gonzalez TB, Arevalo ANG, Almeida JP, Bacal F, Oliveira GMM, Lacerda MVG, Barberato SH, Chagas ACP, Rochitte CE, Ramires JAF, Kalil Filho R, Hajjar LA. The Heart and COVID-19: What Cardiologists Need to Know. Arq Bras Cardiol. 2020 May 11;114(5):805-816. doi: 10.36660/abc.20200279. English, Portuguese. — View Citation

Demeco A, Marotta N, Barletta M, Pino I, Marinaro C, Petraroli A, Moggio L, Ammendolia A. Rehabilitation of patients post-COVID-19 infection: a literature review. J Int Med Res. 2020 Aug;48(8):300060520948382. doi: 10.1177/0300060520948382. — View Citation

Du Z, Xu X, Wu Y, Wang L, Cowling BJ, Meyers LA. Serial Interval of COVID-19 among Publicly Reported Confirmed Cases. Emerg Infect Dis. 2020 Jun;26(6):1341-1343. doi: 10.3201/eid2606.200357. Epub 2020 Jun 17. — View Citation

Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086. Erratum In: Am J Respir Crit Care Med. 2020 Feb 1;201(3):393. — View Citation

Gonzalez J, Zuil M, Benitez ID, de Gonzalo-Calvo D, Aguilar M, Santisteve S, Vaca R, Minguez O, Seck F, Torres G, de Batlle J, Gomez S, Barril S, Moncusi-Moix A, Monge A, Gort-Paniello C, Ferrer R, Ceccato A, Fernandez L, Motos A, Riera J, Menendez R, Garcia-Gasulla D, Penuelas O, Labarca G, Caballero J, Barbera C, Torres A, Barbe F. One Year Overview and Follow-Up in a Post-COVID Consultation of Critically Ill Patients. Front Med (Lausanne). 2022 Jul 14;9:897990. doi: 10.3389/fmed.2022.897990. eCollection 2022. — View Citation

Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. — View Citation

Guler MA, Guler K, Guneser Gulec M, Ozdoglar E. Working From Home During a Pandemic: Investigation of the Impact of COVID-19 on Employee Health and Productivity. J Occup Environ Med. 2021 Sep 1;63(9):731-741. doi: 10.1097/JOM.0000000000002277. — View Citation

Hui DS, Wong KT, Ko FW, Tam LS, Chan DP, Woo J, Sung JJ. The 1-year impact of severe acute respiratory syndrome on pulmonary function, exercise capacity, and quality of life in a cohort of survivors. Chest. 2005 Oct;128(4):2247-61. doi: 10.1378/chest.128.4.2247. — View Citation

Hussain A, Baleanu D, Adeel M. Existence of solution and stability for the fractional order novel coronavirus (nCoV-2019) model. Adv Differ Equ. 2020;2020(1):384. doi: 10.1186/s13662-020-02845-0. Epub 2020 Jul 25. — View Citation

Ianniello S, Di Giacomo V, Sessa B, Miele V. First-line sonographic diagnosis of pneumothorax in major trauma: accuracy of e-FAST and comparison with multidetector computed tomography. Radiol Med. 2014 Sep;119(9):674-80. doi: 10.1007/s11547-014-0384-1. Epub 2014 Jan 28. — View Citation

Kang N, Shin SH, Gu S, Kang D, Cho J, Jeong HJ, Suh GY, Lee H, Park HY. The impact of low forced vital capacity on behavior restrictions in a population with airflow obstruction. J Thorac Dis. 2019 Apr;11(4):1316-1324. doi: 10.21037/jtd.2019.03.77. — View Citation

Kanne JP, Little BP, Chung JH, Elicker BM, Ketai LH. Essentials for Radiologists on COVID-19: An Update-Radiology Scientific Expert Panel. Radiology. 2020 Aug;296(2):E113-E114. doi: 10.1148/radiol.2020200527. Epub 2020 Feb 27. No abstract available. — View Citation

Lopes AJ, de Menezes SL, Dias CM, de Oliveira JF, Mainenti MR, Guimaraes FS. Comparison between cardiopulmonary exercise testing parameters and computed tomography findings in patients with thoracic sarcoidosis. Lung. 2011 Oct;189(5):425-31. doi: 10.1007/s00408-011-9316-1. Epub 2011 Aug 20. — View Citation

Lopes AJ, Mafort TT, da Cal MS, Monnerat LB, Litrento PF, Ramos I, de Oliveira RFJ, da Costa CH, Rufino R. Impulse Oscillometry Findings and Their Associations With Lung Ultrasound Signs in COVID-19 Survivors. Respir Care. 2021 Nov;66(11):1691-1698. doi: 10.4187/respcare.09193. Epub 2021 Sep 7. — View Citation

Lutchmansingh DD, Knauert MP, Antin-Ozerkis DE, Chupp G, Cohn L, Dela Cruz CS, Ferrante LE, Herzog EL, Koff J, Rochester CL, Ryu C, Singh I, Tickoo M, Winks V, Gulati M, Possick JD. A Clinic Blueprint for Post-Coronavirus Disease 2019 RECOVERY: Learning From the Past, Looking to the Future. Chest. 2021 Mar;159(3):949-958. doi: 10.1016/j.chest.2020.10.067. Epub 2020 Nov 4. — View Citation

Mafort TT, Rufino R, da Costa CH, da Cal MS, Monnerat LB, Litrento PF, Parra LLZ, Marinho ASES, Lopes AJ. One-month outcomes of patients with SARS-CoV-2 infection and their relationships with lung ultrasound signs. Ultrasound J. 2021 Apr 9;13(1):19. doi: 10.1186/s13089-021-00223-9. — View Citation

Mitchell JH, Levine BD, McGuire DK. The Dallas Bed Rest and Training Study: Revisited After 50 Years. Circulation. 2019 Oct 15;140(16):1293-1295. doi: 10.1161/CIRCULATIONAHA.119.041046. Epub 2019 Oct 14. No abstract available. — View Citation

NEWS MEDICAL. Spiropalm Handheld Spirometer from COSMED. Medical Devices, Spirometers, 2022. Disponível em: <https://www.news- medical.net/Spiropalm-Handheld-Spirometer-from-COSMED>. Acesso em 10 de novembro de 2022

Ngai JC, Ko FW, Ng SS, To KW, Tong M, Hui DS. The long-term impact of severe acute respiratory syndrome on pulmonary function, exercise capacity and health status. Respirology. 2010 Apr;15(3):543-50. doi: 10.1111/j.1440-1843.2010.01720.x. Epub 2010 Mar 19. — View Citation

Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available. Erratum In: JAMA. 2020 Apr 28;323(16):1619. — View Citation

Oostveen E, Boda K, van der Grinten CP, James AL, Young S, Nieland H, Hantos Z. Respiratory impedance in healthy subjects: baseline values and bronchodilator response. Eur Respir J. 2013 Dec;42(6):1513-23. doi: 10.1183/09031936.00126212. Epub 2013 Apr 18. — View Citation

Oreshkova N, Molenaar RJ, Vreman S, Harders F, Oude Munnink BB, Hakze-van der Honing RW, Gerhards N, Tolsma P, Bouwstra R, Sikkema RS, Tacken MG, de Rooij MM, Weesendorp E, Engelsma MY, Bruschke CJ, Smit LA, Koopmans M, van der Poel WH, Stegeman A. SARS-CoV-2 infection in farmed minks, the Netherlands, April and May 2020. Euro Surveill. 2020 Jun;25(23):2001005. doi: 10.2807/1560-7917.ES.2020.25.23.2001005. Erratum In: Euro Surveill. 2021 Mar;26(12): — View Citation

Pasnick S, Carlos WG, Dela Cruz CS, Gross JE, Garrison G, Jamil S. SARS-CoV-2 Transmission and the Risk of Aerosol Generating Procedures. Am J Respir Crit Care Med. 2020 Jun 30. doi: 10.1164/rccm.2020C11. Online ahead of print. No abstract available. — View Citation

Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9. — View Citation

Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. doi: 10.1164/rccm.200407-855OC. Epub 2005 Jan 21. — View Citation

Sant'Anna M Jr, Carvalhal RF, Oliveira FDFB, Zin WA, Lopes AJ, Lugon JR, Guimaraes FS. Respiratory mechanics of patients with morbid obesity. J Bras Pneumol. 2019 Oct 17;45(5):e20180311. doi: 10.1590/1806-3713/e20180311. eCollection 2019. — View Citation

Savioli F, Rocha LL. Coagulation profile in severe COVID-19 patients: what do we know so far? Rev Bras Ter Intensiva. 2020 Jun;32(2):197-199. doi: 10.5935/0103-507x.20200031. Epub 2020 Jun 24. No abstract available. — View Citation

Sibila M, Guevara G, Cuadrado R, Pleguezuelos P, Perez D, Perez de Rozas A, Huerta E, Llorens A, Valero O, Perez M, Lopez C, Krejci R, Segales J. Comparison of Mycoplasma hyopneumoniae and porcine circovirus 2 commercial vaccines efficacy when applied separate or combined under experimental conditions. Porcine Health Manag. 2020 May 4;6:11. doi: 10.1186/s40813-020-00148-0. eCollection 2020. — View Citation

Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. Proposal for International Standardization of the Use of Lung Ultrasound for Patients With COVID-19: A Simple, Quantitative, Reproducible Method. J Ultrasound Med. 2020 Jul;39(7):1413-1419. doi: 10.1002/jum.15285. Epub 2020 Apr 13. — View Citation

Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available. — View Citation

Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13. — View Citation

Thachil J, Tang N, Gando S, Falanga A, Cattaneo M, Levi M, Clark C, Iba T. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026. doi: 10.1111/jth.14810. Epub 2020 Apr 27. No abstract available. — View Citation

Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaro J. Respiratory function in patients post-infection by COVID-19: a systematic review and meta-analysis. Pulmonology. 2021 Jul-Aug;27(4):328-337. doi: 10.1016/j.pulmoe.2020.10.013. Epub 2020 Nov 25. — View Citation

van Kampen JJA, van de Vijver DAMC, Fraaij PLA, Haagmans BL, Lamers MM, Okba N, van den Akker JPC, Endeman H, Gommers DAMPJ, Cornelissen JJ, Hoek RAS, van der Eerden MM, Hesselink DA, Metselaar HJ, Verbon A, de Steenwinkel JEM, Aron GI, van Gorp ECM, van Boheemen S, Voermans JC, Boucher CAB, Molenkamp R, Koopmans MPG, Geurtsvankessel C, van der Eijk AA. Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19). Nat Commun. 2021 Jan 11;12(1):267. doi: 10.1038/s41467-020-20568-4. — View Citation

Williams FMK, Muirhead N, Pariante C. Covid-19 and chronic fatigue. BMJ. 2020 Jul 30;370:m2922. doi: 10.1136/bmj.m2922. No abstract available. — View Citation

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. — View Citation

Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation

Ye Z, Wang Y, Colunga-Lozano LE, Prasad M, Tangamornsuksan W, Rochwerg B, Yao L, Motaghi S, Couban RJ, Ghadimi M, Bala MM, Gomaa H, Fang F, Xiao Y, Guyatt GH. Efficacy and safety of corticosteroids in COVID-19 based on evidence for COVID-19, other coronavirus infections, influenza, community-acquired pneumonia and acute respiratory distress syndrome: a systematic review and meta-analysis. CMAJ. 2020 Jul 6;192(27):E756-E767. doi: 10.1503/cmaj.200645. Epub 2020 May 14. — View Citation

Zhang T, Wu Q, Zhang Z. Probable Pangolin Origin of SARS-CoV-2 Associated with the COVID-19 Outbreak. Curr Biol. 2020 Apr 6;30(7):1346-1351.e2. doi: 10.1016/j.cub.2020.03.022. Epub 2020 Mar 19. Erratum In: Curr Biol. 2020 Apr 20;30(8):1578. — View Citation

* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test coupled into the measurement of pulmonary ventilation	The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity	October 2023
Secondary	Impulse oscillometry	The IOS will be performed using an impulse oscillometer (Quark i2m, Cosmed, Rome Italy). During the IOS assessment, participants will be guided to stay seated, keeping the head in a neutral position, with manual support on the cheeks and with the nostrils occluded by a clip and then they will breathe usually for 40 seconds (ALBUQUERQUE et al., 2015). The values of acceptable minimum coherence will be =0.9 Hz. The following resistive and reactive parameters were evaluated: Rsr at 4 Hz (R4), 6 Hz (R6), 10 Hz (R10) and 20 Hz (R20); average resistance between 4-20 Hz (Rm); heterogeneity of resistance between R4 and R20 (R4-R20); resonant frequency (Fres); and area under reactance curve (AX). The values of R4, R6, R10 and R20 will be considered 34 abnormal when =150% of predicted (OOSTVEEN et al., 2013). A change in Fres and AX will be considered when >12 Hz and >3.60 cm H2O/L/s, respectively (BERGER et al., 2013).	October 2023
Secondary	Spirometry	It is a procedure that allows the diagnosis of ventilatory disorders and is capable of measuring the patient's pulmonary function - evaluating the volume and velocity of the air blown. It is done with the aid of a device, the spirometer. The patient breathes into this device and internal sensors measure the amount of air and air movement in the lungs.	October 2023
Secondary	Lung ultrasound	Participants will perform the LUS on Aplio XG equipment Aplio XG (Toshiba Medical Systems, Tokyo, Japan) coupled to a linear transducer 7.5-10 megahertz (MHz) multi-frequency transducer or a 3.5-5 MHz convex transducer in B. All USP evaluations will be performed by the authors who, although not whether they are radiologists, they are all employees of Policlínica Piquet Carneiro and have at least least 9 years of USP experience at the participant screening site. All USP assessments will be performed by 2 examiners and, when disagreement between them will be resolved through collective discussion. With participants in a seated position, the capture of USP signals will be done in 6 areas of each hemithorax as follows (SOUMMER et al., 2012): two anterior, two side and two back. In the evaluation of the pathological signs of USP, the investigators will search for B lines >2, coalescing B lines, and subpleural consolidations (MAFORT et al., 2021).	October 2023
Secondary	Functional Status scale PCFS	The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19, being a self-administered questionnaire for the patient who will be informed: how much are you currently affected in your daily life by COVID 19? The patient will indicate in a classification from 0 to 4 their degree of functional status	October 2023