Clinical trial NCT04753346: Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19
Official title: Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19 and Investigation of Factors Affecting Physical Capacity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID 19
Keywords: Cardiopulmonary exercise test
Exercise capacity
COVID 19
6 minute walk test
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients applying to COVID-19 follow-up clinics

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: 1-6 months
measure: Oxygen uptake at anaerobic threshold
timeFrame: 1-6 months
measure: Borg rating of perceived exertion scale
timeFrame: 1-6 months
measure: Walk distance
timeFrame: 1-6 months
Secondary outcomes:
measure: Borg dyspnea scale
timeFrame: 1-6 months
measure: Anxiety score
timeFrame: 1-6 months
measure: Depression score
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department
Study officials:
References: