Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19

Study Overview
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Brief Summary
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COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus named as SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have a devastating effect on many organs, the respiratory tract is particularly affected. In the course of the disease, a wide clinical spectrum is observed, from flu-like illness to lung failure. Some of the patients who survived the disease continue to have problems such as shortness of breath, fatigue, decrease in walking distance, decrease in participation in daily life activities. These problems suggest that the effects on respiratory and cardiac functions continue even after the disease ends. This study was designed to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.

Detailed Description
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Aims of the research are that demonstrate change in cardiopulmonary fitness level in patients with COVID-19 according to normal values and reveal the relationship of this change with age, gender, physical activity level, disease severity and accompanying medical conditions. Patients older than 18 years old who are diagnosed with COVID-19 according to clinical symptoms and rt-PCR test positivity and at least 30 days past the end of their symptoms are accepted for the study. According to World Health Organization's (WHO) classification, COVID-19 disease severity is determined. Physical activity level of the patients before COVID-19 is evaluated with International Physical Activity Questionnaire. Risk of anxiety and depression of the patients is identified with Hospital Anxiety and Depression Scale (HADS), which has 14 questions. To evaluate cardiopulmonary fitness level, cardiopulmonary exercise test (CPET) and 6-minute walk test are applied. Cardiopulmonary exercise test is gold standard to determine cardiac and respiratory functions. Pulmonary function test is performed to identify the conditions that affect the results of cardiopulmonary exercise test.

Official Title
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Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19 and Investigation of Factors Affecting Physical Capacity

Conditions
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COVID 19

Intervention / Treatment
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* Other: Physical Activity Level
* Other: Anxiety and Depression Assessment
* Diagnostic Test: Exercise Capacity
* Diagnostic Test: Pulmonary Function Test
* Diagnostic Test: Cardiopulmonary Fitness Level
* Other: Cognitive Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of SARS-Cov2 with a positive result of reverse polymerase-transcriptase chain reaction test It must have been at least 30 days after symptoms of COVID-19 improved. Exclusion Criteria: 5 days after acute myocardial infarction Unstable angina Active endocarditis, myocarditis or pericarditis Symptomatic severe aortic stenosis Uncontrolled heart failure Acute pulmonary embolus, pulmonary infarction or thrombosis of lower extremities Suspected dissecting aneurysm Uncontrolled asthma Room air desaturation at rest (O2 ⩽85%) Respiratory failure Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise Mental impairment Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic) High-degree atrioventricular block Orthopaedic, neurological or systemic impairments that leading to inability to perform test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild Disease<br>Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia. | Other: Physical Activity Level<br>* International Physical Activity Questionnaire<br>Other: Anxiety and Depression Assessment<br>* Hospital Anxiety and Depression Scale<br>Diagnostic Test: Exercise Capacity<br>* 6 Minute Walk Test<br>Diagnostic Test: Pulmonary Function Test<br>* Spirometry<br>Diagnostic Test: Cardiopulmonary Fitness Level<br>* Cardiopulmonary Exercise Test<br>Other: Cognitive Assessment<br>* Montreal Cognitive Assessment<br>|
| Pneumonia<br>Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air | Other: Physical Activity Level<br>* International Physical Activity Questionnaire<br>Other: Anxiety and Depression Assessment<br>* Hospital Anxiety and Depression Scale<br>Diagnostic Test: Exercise Capacity<br>* 6 Minute Walk Test<br>Diagnostic Test: Pulmonary Function Test<br>* Spirometry<br>Diagnostic Test: Cardiopulmonary Fitness Level<br>* Cardiopulmonary Exercise Test<br>Other: Cognitive Assessment<br>* Montreal Cognitive Assessment<br>|
| Severe Pneumonia<br>Patients with clinical signs of pneumonia (fever, cough, dyspnoea,fast breathing) plus one of the following: respiratory rate > 30 breaths/min; severe respiratory distress; or SpO2 < 90% on room air. | Other: Physical Activity Level<br>* International Physical Activity Questionnaire<br>Other: Anxiety and Depression Assessment<br>* Hospital Anxiety and Depression Scale<br>Diagnostic Test: Exercise Capacity<br>* 6 Minute Walk Test<br>Diagnostic Test: Pulmonary Function Test<br>* Spirometry<br>Diagnostic Test: Cardiopulmonary Fitness Level<br>* Cardiopulmonary Exercise Test<br>Other: Cognitive Assessment<br>* Montreal Cognitive Assessment<br>|
| Critical Disease<br>Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock. | Other: Physical Activity Level<br>* International Physical Activity Questionnaire<br>Other: Anxiety and Depression Assessment<br>* Hospital Anxiety and Depression Scale<br>Diagnostic Test: Exercise Capacity<br>* 6 Minute Walk Test<br>Diagnostic Test: Pulmonary Function Test<br>* Spirometry<br>Diagnostic Test: Cardiopulmonary Fitness Level<br>* Cardiopulmonary Exercise Test<br>Other: Cognitive Assessment<br>* Montreal Cognitive Assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake | Cardiopulmonary exercise test | 1-6 months | 
| Oxygen uptake at anaerobic threshold | Cardiopulmonary exercise test | 1-6 months | 
| Borg rating of perceived exertion scale | Cardiopulmonary exercise test | 1-6 months | 
| Walk distance | 6 minute walk test | 1-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg dyspnea scale | Cardiopulmonary exercise test | 1-6 months | 
| Anxiety score | Hospital Anxiety and Depression Scale | 1-6 months | 
| Depression score | Hospital Anxiety and Depression Scale | 1-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary exercise test, Exercise capacity, COVID 19, 6 minute walk test