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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID 19
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Burak K Turan; Phone Number: 90(312)5082822; Email: burakkamilturan@gmail.com
• Study Contact Backup: Name: Yesim Aytür; Phone Number: 90(312)5082822; Email: kurtais@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Recruiting
    • Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department
    • Contact: Burak K Turan; Phone Number: 90(312)5082822; Email: burakkamilturan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients applying to COVID-19 follow-up clinics

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild Disease; Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.	Other: Physical Activity Level; International Physical Activity Questionnaire; Other: Anxiety and Depression Assessment; Hospital Anxiety and Depression Scale; Diagnostic test: Exercise Capacity; 6 Minute Walk Test; Diagnostic test: Pulmonary Function Test; Spirometry; Diagnostic test: Cardiopulmonary Fitness Level; Cardiopulmonary Exercise Test; Other: Cognitive Assessment; Montreal Cognitive Assessment
Pneumonia; 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; International Physical Activity Questionnaire; Other: Anxiety and Depression Assessment; Hospital Anxiety and Depression Scale; Diagnostic test: Exercise Capacity; 6 Minute Walk Test; Diagnostic test: Pulmonary Function Test; Spirometry; Diagnostic test: Cardiopulmonary Fitness Level; Cardiopulmonary Exercise Test; Other: Cognitive Assessment; Montreal Cognitive Assessment
Severe Pneumonia; 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; International Physical Activity Questionnaire; Other: Anxiety and Depression Assessment; Hospital Anxiety and Depression Scale; Diagnostic test: Exercise Capacity; 6 Minute Walk Test; Diagnostic test: Pulmonary Function Test; Spirometry; Diagnostic test: Cardiopulmonary Fitness Level; Cardiopulmonary Exercise Test; Other: Cognitive Assessment; Montreal Cognitive Assessment
Critical Disease; Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.	Other: Physical Activity Level; International Physical Activity Questionnaire; Other: Anxiety and Depression Assessment; Hospital Anxiety and Depression Scale; Diagnostic test: Exercise Capacity; 6 Minute Walk Test; Diagnostic test: Pulmonary Function Test; Spirometry; Diagnostic test: Cardiopulmonary Fitness Level; Cardiopulmonary Exercise Test; Other: Cognitive Assessment; Montreal Cognitive Assessment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID 19; Exercise capacity; 6 minute walk test; Cardiopulmonary exercise test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: I11-670-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No