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

Recruiting

• Conditions: COVID 19
• Interventions: 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

• Registration Number: NCT04753346
• Lead Sponsor: Ankara University

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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study Start: 2021-02-15
• Study First Posted: 2021-02-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-15
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild Disease	Pulmonary Function Test	Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.
Pneumonia	Cardiopulmonary Fitness Level	Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air
Pneumonia	Anxiety and Depression Assessment	Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air
Pneumonia	Cognitive Assessment	Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air
Severe Pneumonia	Exercise Capacity	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.
Mild Disease	Physical Activity Level	Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.
Mild Disease	Anxiety and Depression Assessment	Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.
Mild Disease	Exercise Capacity	Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.
Mild Disease	Cardiopulmonary Fitness Level	Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.
Mild Disease	Cognitive Assessment	Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.
Pneumonia	Physical Activity Level	Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air
Severe Pneumonia	Cardiopulmonary Fitness Level	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.
Pneumonia	Exercise Capacity	Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air
Pneumonia	Pulmonary Function Test	Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air
Severe Pneumonia	Physical Activity Level	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.
Severe Pneumonia	Anxiety and Depression Assessment	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.
Severe Pneumonia	Cognitive Assessment	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.
Critical Disease	Exercise Capacity	Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.
Severe Pneumonia	Pulmonary Function Test	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.
Critical Disease	Cognitive Assessment	Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.
Critical Disease	Physical Activity Level	Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.
Critical Disease	Anxiety and Depression Assessment	Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.
Critical Disease	Pulmonary Function Test	Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.
Critical Disease	Cardiopulmonary Fitness Level	Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake	1-6 months	Cardiopulmonary exercise test
Borg rating of perceived exertion scale	1-6 months	Cardiopulmonary exercise test
Oxygen uptake at anaerobic threshold	1-6 months	Cardiopulmonary exercise test
Walk distance	1-6 months	6 minute walk test

Secondary Outcome Measures

Name	Time	Method
Borg dyspnea scale	1-6 months	Cardiopulmonary exercise test
Anxiety score	1-6 months	Hospital Anxiety and Depression Scale
Depression score	1-6 months	Hospital Anxiety and Depression Scale

Trial Locations

Locations (1)

Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department; 🇹🇷 Ankara, Turkey