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

COVID 19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753346
• Other study ID #: I11-670-20
• Status: Recruiting
• Start date: February 15, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Ankara University
• Contact: Burak K Turan
• Phone: 90(312)5082822
• Email: burakkamilturan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Other:
• Physical Activity Level
International Physical Activity Questionnaire
• Anxiety and Depression Assessment
Hospital Anxiety and Depression Scale

Diagnostic Test:
• Exercise Capacity
6 Minute Walk Test
• Pulmonary Function Test
Spirometry
• Cardiopulmonary Fitness Level
Cardiopulmonary Exercise Test

Other:
• Cognitive Assessment
Montreal Cognitive Assessment

Locations

Country	Name	City	State
Turkey	Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake	Cardiopulmonary exercise test	1-6 months
Primary	Oxygen uptake at anaerobic threshold	Cardiopulmonary exercise test	1-6 months
Primary	Borg rating of perceived exertion scale	Cardiopulmonary exercise test	1-6 months
Primary	Walk distance	6 minute walk test	1-6 months
Secondary	Borg dyspnea scale	Cardiopulmonary exercise test	1-6 months
Secondary	Anxiety score	Hospital Anxiety and Depression Scale	1-6 months
Secondary	Depression score	Hospital Anxiety and Depression Scale	1-6 months