Patients Post-COVID-19COR-PHYSNCT05118711
Sequelae of COVID-19 With Focus on Exercise Capacity and Underlying Mechanisms
An observational study of Patients Post-COVID-19 and Controls, run by Arno Schmidt-Trucksäss at 1 site in Switzerland.
Trial summary
The project is designed as a cross-sectional study and aims to examine long-term consequences of coronavirus disease 2019 (COVID-19) for selected bio-behavioural parameters while taking the disease course severity into account. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Post-COVID-19, Controls
- What is being tested?
- Cardiorespiratory fitness, Lung function and Muscular strength and balance tests
- Type of treatment
- Vaccines
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jan 2023to Mar 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Previously hospitalised patients recovering from COVID-19 and fully vaccinated controls with no history of symptomatic COVID-19. Recruitment of patients will be done via the University Hospital of Basel, Switzerland, the Clinic Barmelweid, Barmelweid, Switzerland, and Cantonal Hospital Olten, Olten, Switzerland. Participants for the control group will be recruited prospectively through unaddressed letters distributed in the Basel-Stadt area, newspaper, internet-based media, and word-of-mouth. Recruitment will continue until the number of valid datasets corresponds to the calculated sample size.
Who may be able to join
- tested positive for SARS-CoV-2 using antigen- or PCR tests within the last 18 months
- previous hospitalisation due to COVID-19
- fully vaccinated (only for controls)
Who cannot join
- inability to follow the study procedures (e.g. due to language barriers, psychological disorders, dementia, etc.),
- known pregnancy or lactating women,
- presence of any contraindications for exercising until maximum exhaustion, including insufficient blood pressure control (systolic >170 mmHg, diastolic >100 mmHg), ongoing cancer treatment, unstable angina pectoris, uncontrolled bradyarrhythmia or tachyarrhythmia, severe uncorrected valvular heart disease, clinically relevant acute infection, any form of musculoskeletal injury,
- participating in any interventional clinical trial within the last four weeks,
- previous participation in the current study
- history of symptomatic COVID-19 (only for controls)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052
Arno Schmidt-Trucksäss, MD, MA, FESC, + 41 61 377 87 41, arno.schmidt-trucksaess@unibas.ch
About this study
Official title: COVID-19 Severity, Long-term Consequences for Exercise Capacity and Link to Associated Mechanisms
The project is designed as a cross-sectional study and aims to examine long-term consequences of coronavirus disease 2019 (COVID-19) for selected bio-behavioural parameters while taking the disease course severity into account.
- Conditions
- Patients Post-COVID-19, Controls
- Being tested
- Cardiorespiratory fitness, Lung function, Muscular strength and balance tests, Micro- and macrovascular endothelial function and cardiac function, Blood sampling and analysis
- Keywords
- SARS-CoV-2, Coronavirus, Sequelae, Exercise intolerance, Cardiopulmonary exercise testing
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory fitnessDiagnostic test
Cardiopulmonary exercise testing
Lung functionDiagnostic test
Body plethysmography
Muscular strength and balance testsDiagnostic test
Handgrip strength test, mid-thigh pull test and standing balance test in static tandem stance
Micro- and macrovascular endothelial function and cardiac functionDiagnostic test
Measurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography
Blood sampling and analysisDiagnostic test
Blood sampling by venepuncture
Physical activityDiagnostic test
Physical activity surveillance using accelerometers
QuestionnairesDiagnostic test
Global physical activity questionnaire (GPAQ), short-form 8 health survey (SF-8), barriers to physical activity, fatigue assessment scale (FAS), modified medical research council dyspnea scale (mMRC), depression, anxiety, and stress scale (DASS21), post-COVID-19 syndrome symptoms
Body compositionDiagnostic test
Dual-energy x-ray absorptiometry (DXA)
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 (18 months post-infection) | Individuals with a positive Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) antigen-/polymerase chain reaction (PCR) test within the last 18 months that required hospitalisation. Symptoms typically worsened within a period of 5 to 10 days leading to e.g., prolonged fever, feeling of sickness and/or shortness of breath. This also includes individuals hospitalised in an intensive care ward. Individuals need to be hospitalised due to COVID-19 and not only with COVID-19. Receives: Diagnostic Test: Cardiorespiratory fitness; Diagnostic Test: Lung function; Diagnostic Test: Muscular strength and balance tests; Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function; Diagnostic Test: Blood sampling and analysis; Diagnostic Test: Physical activity; Diagnostic Test: Questionnaires; Diagnostic Test: Body composition | |
| Control group | Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection. Receives: Diagnostic Test: Cardiorespiratory fitness; Diagnostic Test: Lung function; Diagnostic Test: Muscular strength and balance tests; Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function; Diagnostic Test: Blood sampling and analysis; Diagnostic Test: Physical activity; Diagnostic Test: Questionnaires; Diagnostic Test: Body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (as % of predicted V̇O2max)
Measured during cardiopulmonary exercise testing on a cycle ergometer.
Measured: 1.5 hours after inclusion in study
Secondary outcomes (14)
Forced expiratory volume in 1 s (as % of predicted)
Measured during bodyplethysmography.
Measured: 1.5 hours after inclusion in study
Forced vital capacity (as % of predicted)
Measured during bodyplethysmography.
Measured: 1.5 hours after inclusion in study
Total lung capacity (as % of predicted)
Measured during bodyplethysmography.
Measured: 1.5 hours after inclusion in study
Diffusion capacity of the lungs (as % of predicted)
Measured during bodyplethysmography.
Measured: 1.5 hours after inclusion in study
Muscle oxygenation at peak exercise (in %)
Measured using near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Measured: 1.5 hours after inclusion in study
Cardiac output at peak exercise (in mL)
Measured non-invasive using the PhysioFlow device during cardiopulmonary exercise testing on a cycle ergometer.
Measured: 1.5 hours after inclusion in study
Handgrip strength (in N)
Measured by a handheld dynamometer.
Measured: 1 hour after inclusion in study
Handgrip rate of force development (in N/s)
Measured by a handheld dynamometer.
Measured: 1 hour after inclusion in study
Macrovascular flow-mediated dilation at rest (in %)
Measured by ultrasound.
Measured: 0.5 hours after inclusion in study
Microvascular flow-mediated dilation at rest (in %)
Measured by retinal vessel analysis.
Measured: 2 to 14 days after inclusion in study
Fatigue Assessment Scale (FAS) score
Scores range from 5 to 50 with higher scores indicating more severe fatigue.
Measured: 2 to 14 days after inclusion in study
Score of depression, anxiety, and stress questionnaire (DASS21)
Scores range from 0 to 63 with higher scores indicating worse mental health.
Measured: 2 to 14 days after inclusion in study
Health distance
The statistical (Mahalanobis) distance (health distance) is a composite measure of various health biomarkers
Measured: Calculated during statistical analysis
Cerebral oxygenation at peak exercise (in %)
Measured using functional near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Measured: 1.5 hours after inclusion in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start3 Jan 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Post-COVID-19Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arno Schmidt-Trucksäss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arno Schmidt-Trucksäss, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, Prof., Principal investigator, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118711
- Sponsor's protocol ID
- EKNZ 2021-01039
- Acronym
- COR-PHYS
- Status last verified
- Feb 2023
- First submitted
- 8 Nov 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Severity, Long-term Consequences for Exercise Capacity and Link to Associated Mechanisms
- ClinicalTrials.gov ID
- NCT05118711
- Acronym / sponsor ID
- COR-PHYS / EKNZ 2021-01039
- Conditions
- Patients Post-COVID-19, Controls
- Keywords
- SARS-CoV-2, Coronavirus, Sequelae, Exercise intolerance, Cardiopulmonary exercise testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Arno Schmidt-TrucksässUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 12 Nov 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.
The project is designed as a cross-sectional study and aims to examine long-term consequences of coronavirus disease 2019 (COVID-19) for selected bio-behavioural parameters while taking the disease course severity into account.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 (18 months post-infection) | – | Diagnostic Test: Cardiorespiratory fitness, Diagnostic Test: Lung function, Diagnostic Test: Muscular strength and balance tests, Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function, Diagnostic Test: Blood sampling and analysis, Diagnostic Test: Physical activity, Diagnostic Test: Questionnaires, Diagnostic Test: Body compositionIndividuals with a positive Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) antigen-/polymerase chain reaction (PCR) test within the last 18 months that required hospitalisation. Symptoms typically worsened within a period of 5 to 10 days leading to e.g., prolonged fever, feeling of sickness and/or shortness of breath. This also includes individuals hospitalised in an intensive care ward. Individuals need to be hospitalised due to COVID-19 and not only with COVID-19. |
| Control group | – | Diagnostic Test: Cardiorespiratory fitness, Diagnostic Test: Lung function, Diagnostic Test: Muscular strength and balance tests, Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function, Diagnostic Test: Blood sampling and analysis, Diagnostic Test: Physical activity, Diagnostic Test: Questionnaires, Diagnostic Test: Body compositionAge-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Previously hospitalised patients recovering from COVID-19 and fully vaccinated controls with no history of symptomatic COVID-19. Recruitment of patients will be done via the University Hospital of Basel, Switzerland, the Clinic Barmelweid, Barmelweid, Switzerland, and Cantonal Hospital Olten, Olten, Switzerland. Participants for the control group will be recruited prospectively through unaddressed letters distributed in the Basel-Stadt area, newspaper, internet-based media, and word-of-mouth. Recruitment will continue until the number of valid datasets corresponds to the calculated sample size.
Key inclusion criteria (3 listed)
- tested positive for SARS-CoV-2 using antigen- or PCR tests within the last 18 months
- previous hospitalisation due to COVID-19
- fully vaccinated (only for controls)
Key exclusion criteria (6 listed)
- inability to follow the study procedures (e.g. due to language barriers, psychological disorders, dementia, etc.),
- known pregnancy or lactating women,
- presence of any contraindications for exercising until maximum exhaustion, including insufficient blood pressure control (systolic >170 mmHg, diastolic >100 mmHg), ongoing cancer treatment, unstable angina pectoris, uncontrolled bradyarrhythmia or tachyarrhythmia, severe uncorrected valvular heart disease, clinically relevant acute infection, any form of musculoskeletal injury,
- participating in any interventional clinical trial within the last four weeks,
- previous participation in the current study
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 |
|---|---|---|
| Cardiorespiratory fitnessCardiopulmonary exercise testing | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| Lung functionBody plethysmography | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| Muscular strength and balance testsHandgrip strength test, mid-thigh pull test and standing balance test in static tandem stance | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| Micro- and macrovascular endothelial function and cardiac functionMeasurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| Blood sampling and analysisBlood sampling by venepuncture | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| Physical activityPhysical activity surveillance using accelerometers | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| QuestionnairesGlobal physical activity questionnaire (GPAQ), short-form 8 health survey (SF-8), barriers to physical activity, fatigue assessment scale (FAS), modified medical research council dyspnea scale (mMRC), depression, anxiety, and stress scale (DASS21), post-COVID-19 syndrome symptoms | Diagnostic test | COVID-19 (18 months post-infection), Control group |
| Body compositionDual-energy x-ray absorptiometry (DXA) | Diagnostic test | COVID-19 (18 months post-infection), Control group |
Primary outcome
Cardiorespiratory fitness (as % of predicted V̇O2max)
Time frame: 1.5 hours after inclusion in study
Measured during cardiopulmonary exercise testing on a cycle ergometer.
14 secondary outcomes
Forced expiratory volume in 1 s (as % of predicted)
Time frame: 1.5 hours after inclusion in study
Forced vital capacity (as % of predicted)
Time frame: 1.5 hours after inclusion in study
Total lung capacity (as % of predicted)
Time frame: 1.5 hours after inclusion in study
Diffusion capacity of the lungs (as % of predicted)
Time frame: 1.5 hours after inclusion in study
Muscle oxygenation at peak exercise (in %)
Time frame: 1.5 hours after inclusion in study
Cardiac output at peak exercise (in mL)
Time frame: 1.5 hours after inclusion in study
Handgrip strength (in N)
Time frame: 1 hour after inclusion in study
Handgrip rate of force development (in N/s)
Time frame: 1 hour after inclusion in study
Macrovascular flow-mediated dilation at rest (in %)
Time frame: 0.5 hours after inclusion in study
Microvascular flow-mediated dilation at rest (in %)
Time frame: 2 to 14 days after inclusion in study
Fatigue Assessment Scale (FAS) score
Time frame: 2 to 14 days after inclusion in study
Score of depression, anxiety, and stress questionnaire (DASS21)
Time frame: 2 to 14 days after inclusion in study
Health distance
Time frame: Calculated during statistical analysis
Cerebral oxygenation at peak exercise (in %)
Time frame: 1.5 hours after inclusion in study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Arno Schmidt-Trucksäss, Prof. principal investigator
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
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 Patients Post-COVID-19 and Controls, run by Arno Schmidt-Trucksäss at 1 site in Switzerland.
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 3 inclusion and 6 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 10 Feb 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 Switzerland. 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 Arno Schmidt-Trucksäss, Prof. (+41 61 207 47 40, arno.schmidt-trucksaess@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (as % of predicted V̇O2max) (time frame: 1.5 hours after inclusion in study). 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 10 Feb 2023.