Clinical trial NCT05228678: Persistent Dyspnea in Post COVID_19 and Pulmonary Function
Official title: Persistent Dyspnea in Post-COVID-19 Patients: Value of Cardiopulmonary Exercise Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: covid_19 Patients
Keywords: post covid_19,dyspnea, cardiopulmonary exercise
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are diagnosed as post covid_19 who were admittted to isolation unit of Assiut University Hospitals or visit the post covid_19 outpatient clinic

Brief summary: COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU)

Detailed description: COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU) Many patients with mild or severe COVID-19 do not make a full recovery and have a wide range of chronic symptoms for weeks or months after infection.

Post-COVID-19 syndrome is defined by persistent clinical signs and symptoms that appear while or after suffering COVID-19, persist for more than 12 weeks and cannot be explained by an alternative diagnosis.

Dyspnea is one of the most prevalent symptoms in post-covid-19 patients in up to 29% of patients with post COVID-19 syndrome.

Also, persistent dyspnea in post COVID-19 infection is frequent, it is so far, of unknown mechanism. Cardiopulmonary Exercise Test (CPET) is currently the gold standard technique in the differential diagnosis of dyspnea.

Cardiopulmonary exercise testing (CPET) is useful in the assessment of subjects with chronic lung conditions as it may help to: 1) recognize physiological factors limiting exercise (with or without the presence of psychogenic limiting factors); 2) identify these factors as potential therapeutic targets; 3) allow quantification of the level of impairment; 4) assess the effects of an intervention; and 5) provide prognostic information.

Eligibility criteria: Inclusion Criteria:

* Confirmed or clinically and radiologically highly suspected Covid19-infection
* Symptom duration at least 12 weeks following first occurrence of symptoms
* Patients with dyspnea score 2, 3 and 4 on mMRC
* No other disease that better could explain the symptoms (dyspnea) than Covid-19

Exclusion Criteria:

* Age \<18
* pregnant women
* terminally ill patients
* active covid-19 infection
* previous known severe pulmonary or heart disease
* inability to perform pulmonary function or cardiopulmonary exercise tests.

Primary outcomes:
measure: Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC)
timeFrame: two years
Secondary outcomes:
measure: Assessment of Walking capacity
timeFrame: two years
Other outcomes:
Locations:
Study officials:
References:
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.
citation: Carod-Artal FJ. Post-COVID-19 syndrome: epidemiology, diagnostic criteria and pathogenic mechanisms involved. Rev Neurol. 2021 Jun 1;72(11):384-396. doi: 10.33588/rn.7211.2021230. English, Spanish.
citation: Fernandez-de-Las-Penas C, Palacios-Cena D, Gomez-Mayordomo V, Florencio LL, Cuadrado ML, Plaza-Manzano G, Navarro-Santana M. Prevalence of post-COVID-19 symptoms in hospitalized and non-hospitalized COVID-19 survivors: A systematic review and meta-analysis. Eur J Intern Med. 2021 Oct;92:55-70. doi: 10.1016/j.ejim.2021.06.009. Epub 2021 Jun 16.
citation: Radtke T, Crook S, Kaltsakas G, Louvaris Z, Berton D, Urquhart DS, Kampouras A, Rabinovich RA, Verges S, Kontopidis D, Boyd J, Tonia T, Langer D, De Brandt J, Goertz YMJ, Burtin C, Spruit MA, Braeken DCW, Dacha S, Franssen FME, Laveneziana P, Eber E, Troosters T, Neder JA, Puhan MA, Casaburi R, Vogiatzis I, Hebestreit H. ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev. 2019 Dec 18;28(154):180101. doi: 10.1183/16000617.0101-2018. Print 2019 Dec 31.
citation: Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.