Persistent Dyspnea in Post COVID_19 and Pulmonary Function

• Conditions: covid_19 Patients
• Interventions: Diagnostic Test: cardiopulmonary exercise tests

• Registration Number: NCT05228678
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-06
• Study First Submitted QC: 2022-02-06
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-23
• Study Start: 2022-04-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dyspnea group	cardiopulmonary exercise tests	Patients with prior diagnosis of COVID-19 and present with persistent dyspnea after 12 weeks of occurrence of symptoms every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: - 1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals. 2. The following parameters observed: 1. Metabolic response * Oxygen consumption VO2 (ml/ min): * P ETO2: Is the end-tidal O2 tension as measured from the exhaled air. * P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise. * Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy 2. Ventilatory response * Minute ventilation : * Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum * Tidal volume (VT): * Respiratory frequency (RF)
Control group	cardiopulmonary exercise tests	Patients with prior diagnosis of COVID-19, fully recovered, without persistent dyspnea every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: - 1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals. 2. The following parameters observed: 1. Metabolic response * Oxygen consumption VO2 (ml/ min): * P ETO2: Is the end-tidal O2 tension as measured from the exhaled air. * P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise. * Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy 2. Ventilatory response * Minute ventilation : * Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum * Tidal volume (VT): * Respiratory frequency (RF)

Primary Outcome Measures

Name	Time	Method
Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC)	two years	Aerobic capacity measured as peak oxygen uptake Total lung capacity measured by spirometry

Secondary Outcome Measures

Name	Time	Method
Assessment of Walking capacity	two years	measured by 6 Minute Walk Test