COVID 19NCT04753346
Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19
An observational study of COVID 19, run by Ankara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- Physical Activity Level, Anxiety and Depression Assessment and Exercise Capacity
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients applying to COVID-19 follow-up clinics
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University, Faculty of Medicine, Physical Medicine and Rehabilitation Department
Ankara, 06230
Burak K Turan, 90(312)5082822, burakkamilturan@gmail.com
About this study
Official title: 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.
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.
- Conditions
- COVID 19
- Being tested
- Physical Activity Level, Anxiety and Depression Assessment, Exercise Capacity, Pulmonary Function Test, Cardiopulmonary Fitness Level
- Keywords
- Cardiopulmonary exercise test, Exercise capacity, COVID 19, 6 minute walk test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity LevelOther
International Physical Activity Questionnaire
Anxiety and Depression AssessmentOther
Hospital Anxiety and Depression Scale
Exercise CapacityDiagnostic test
6 Minute Walk Test
Pulmonary Function TestDiagnostic test
Spirometry
Cardiopulmonary Fitness LevelDiagnostic test
Cardiopulmonary Exercise Test
Cognitive AssessmentOther
Montreal Cognitive Assessment
| Study group | Role | What they receive |
|---|---|---|
| Mild Disease | Symptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia. Receives: 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 Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Cardiopulmonary exercise test
Measured: 1-6 months
Oxygen uptake at anaerobic threshold
Cardiopulmonary exercise test
Measured: 1-6 months
Borg rating of perceived exertion scale
Cardiopulmonary exercise test
Measured: 1-6 months
Walk distance
6 minute walk test
Measured: 1-6 months
Secondary outcomes (3)
Borg dyspnea scale
Cardiopulmonary exercise test
Measured: 1-6 months
Anxiety score
Hospital Anxiety and Depression Scale
Measured: 1-6 months
Depression score
Hospital Anxiety and Depression Scale
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Feb 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Kamil Turan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753346
- Sponsor's protocol ID
- I11-670-20
- Status last verified
- Dec 2023
- First submitted
- 12 Feb 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19 and Investigation of Factors Affecting Physical Capacity
- ClinicalTrials.gov ID
- NCT04753346
- Acronym / sponsor ID
- I11-670-20
- Conditions
- COVID 19
- Keywords
- Cardiopulmonary exercise test, Exercise capacity, COVID 19, 6 minute walk test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Disease | – | 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 AssessmentSymptomatic patients meeting the case definition for COVID-19 without evidence of viral pneumonia or hypoxia. |
| Pneumonia | – | 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 AssessmentPatients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air |
| Severe Pneumonia | – | 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 AssessmentPatients 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 | – | 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 AssessmentPatients have one of the following: acute respiratory distress syndrome; sepsis; or septic shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients applying to COVID-19 follow-up clinics
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 5 days after acute myocardial infarction
- Unstable angina
- Active endocarditis, myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity LevelInternational Physical Activity Questionnaire | Other | Critical Disease, Mild Disease, Pneumonia, Severe Pneumonia |
| Anxiety and Depression AssessmentHospital Anxiety and Depression Scale | Other | Critical Disease, Mild Disease, Pneumonia, Severe Pneumonia |
| Exercise Capacity6 Minute Walk Test | Diagnostic test | Critical Disease, Mild Disease, Pneumonia, Severe Pneumonia |
| Pulmonary Function TestSpirometry | Diagnostic test | Critical Disease, Mild Disease, Pneumonia, Severe Pneumonia |
| Cardiopulmonary Fitness LevelCardiopulmonary Exercise Test | Diagnostic test | Critical Disease, Mild Disease, Pneumonia, Severe Pneumonia |
| Cognitive AssessmentMontreal Cognitive Assessment | Other | Critical Disease, Mild Disease, Pneumonia, Severe Pneumonia |
Primary outcome
Peak oxygen uptake
Time frame: 1-6 months
Cardiopulmonary exercise test
Oxygen uptake at anaerobic threshold
Time frame: 1-6 months
Cardiopulmonary exercise test
Borg rating of perceived exertion scale
Time frame: 1-6 months
Cardiopulmonary exercise test
Walk distance
Time frame: 1-6 months
6 minute walk test
3 secondary outcomes
Borg dyspnea scale
Time frame: 1-6 months
Anxiety score
Time frame: 1-6 months
Depression score
Time frame: 1-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
Related trials for COVID 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burak K Turan (90(312)5082822, burakkamilturan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: 1-6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.