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

NCT04753346 | Unknown

• 1 other identifier: I11-670-20
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Keywords

Cardiopulmonary exercise test; Exercise capacity; COVID 19; 6 minute walk test

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Borg dyspnea scale

  1-6 months

• Anxiety score

  1-6 months

• Depression score

  1-6 months

Study Arms (4)

Mild Disease

Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia.

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

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; Other: Anxiety and Depression Assessment; Diagnostic Test: Exercise Capacity; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Cardiopulmonary Fitness Level; Other: 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; Other: Anxiety and Depression Assessment; Diagnostic Test: Exercise Capacity; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Cardiopulmonary Fitness Level; Other: Cognitive Assessment

Critical Disease

Patients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock.

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

Interventions

Physical Activity Level OTHER

International Physical Activity Questionnaire

Critical Disease; Mild Disease; Pneumonia; Severe Pneumonia

Anxiety and Depression Assessment OTHER

Hospital Anxiety and Depression Scale

Critical Disease; Mild Disease; Pneumonia; Severe Pneumonia

Exercise Capacity DIAGNOSTIC_TEST

6 Minute Walk Test

Critical Disease; Mild Disease; Pneumonia; Severe Pneumonia

Pulmonary Function Test DIAGNOSTIC_TEST

Spirometry

Critical Disease; Mild Disease; Pneumonia; Severe Pneumonia

Cardiopulmonary Fitness Level DIAGNOSTIC_TEST

Cardiopulmonary Exercise Test

Critical Disease; Mild Disease; Pneumonia; Severe Pneumonia

Cognitive Assessment OTHER

Montreal Cognitive Assessment

Critical Disease; Mild Disease; Pneumonia; Severe Pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients applying to COVID-19 follow-up clinics

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department

Ankara, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Respiratory Function Tests; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Burak K Turan

CONTACT

90(312)5082822; burakkamilturan@gmail.com

Yesim Aytür

CONTACT

90(312)5082822; kurtais@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 15, 2021
• Study Start: February 15, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

TU (1)