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RecruitingNCT04753346Updated Dec 15, 2023

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

An observational study in COVID 19, sponsored by Ankara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Ankara University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID 19

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Keywords

  • Cardiopulmonary exercise test
  • Exercise capacity
  • COVID 19
  • 6 minute walk test
03

In context

COVID-19

7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.

This study's planned enrollment of 240 is close to the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients applying to COVID-19 follow-up clinics

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPhysical Activity Level

    International Physical Activity Questionnaire

  • OtherAnxiety and Depression Assessment

    Hospital Anxiety and Depression Scale

  • Diagnostic testExercise Capacity

    6 Minute Walk Test

  • Diagnostic testPulmonary Function Test

    Spirometry

  • Diagnostic testCardiopulmonary Fitness Level

    Cardiopulmonary Exercise Test

  • OtherCognitive Assessment

    Montreal Cognitive Assessment

06

What researchers measure

Primary outcomes

  1. Peak oxygen uptake

    Cardiopulmonary exercise test

    Time frame: 1-6 months

  2. Oxygen uptake at anaerobic threshold

    Cardiopulmonary exercise test

    Time frame: 1-6 months

  3. Borg rating of perceived exertion scale

    Cardiopulmonary exercise test

    Time frame: 1-6 months

  4. Walk distance

    6 minute walk test

    Time frame: 1-6 months

Secondary outcomes

  1. Borg dyspnea scale

    Cardiopulmonary exercise test

    Time frame: 1-6 months

  2. Anxiety score

    Hospital Anxiety and Depression Scale

    Time frame: 1-6 months

  3. Depression score

    Hospital Anxiety and Depression Scale

    Time frame: 1-6 months

07

Study locations

1 of 1 sites recruiting
  • Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department
    Ankara, 06230, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04753346
Lead sponsor
Ankara University
Responsible party
Burak Kamil Turan (MD, Ankara University) — Principal investigator
First posted
Feb 15, 2021
Start date
Feb 15, 2021
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Dec 15, 2023

Study contacts

Burak K Turan
Contact
burakkamilturan@gmail.com
90(312)5082822
Yesim Aytür
Contact
kurtais@gmail.com
90(312)5082822

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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