COR-PHYS: Sequelae of COVID-19 With Focus on Exercise Capacity and Underlying Mechanisms
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: Cardiorespiratory fitness
Cardiopulmonary exercise testing
Diagnostic Test: Lung function
Body plethysmography
Diagnostic Test: Muscular strength and balance tests
Handgrip strength test, mid-thigh pull test and standing balance test in static tandem stance
Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function
Measurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography
Diagnostic Test: Blood sampling and analysis
Blood sampling by venepuncture
Diagnostic Test: Physical activity
Physical activity surveillance using accelerometers
Diagnostic Test: Questionnaires
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
Diagnostic Test: Body composition
Dual-energy x-ray absorptiometry (DXA)
|
| Control group Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection. |
Diagnostic Test: Cardiorespiratory fitness
Cardiopulmonary exercise testing
Diagnostic Test: Lung function
Body plethysmography
Diagnostic Test: Muscular strength and balance tests
Handgrip strength test, mid-thigh pull test and standing balance test in static tandem stance
Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function
Measurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography
Diagnostic Test: Blood sampling and analysis
Blood sampling by venepuncture
Diagnostic Test: Physical activity
Physical activity surveillance using accelerometers
Diagnostic Test: Questionnaires
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
Diagnostic Test: Body composition
Dual-energy x-ray absorptiometry (DXA)
|
Outcome Measures
Primary Outcome Measures
- Cardiorespiratory fitness (as % of predicted V̇O2max) [1.5 hours after inclusion in study]
Measured during cardiopulmonary exercise testing on a cycle ergometer.
Secondary Outcome Measures
- Forced expiratory volume in 1 s (as % of predicted) [1.5 hours after inclusion in study]
Measured during bodyplethysmography.
- Forced vital capacity (as % of predicted) [1.5 hours after inclusion in study]
Measured during bodyplethysmography.
- Total lung capacity (as % of predicted) [1.5 hours after inclusion in study]
Measured during bodyplethysmography.
- Diffusion capacity of the lungs (as % of predicted) [1.5 hours after inclusion in study]
Measured during bodyplethysmography.
- Muscle oxygenation at peak exercise (in %) [1.5 hours after inclusion in study]
Measured using near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
- Cardiac output at peak exercise (in mL) [1.5 hours after inclusion in study]
Measured non-invasive using the PhysioFlow device during cardiopulmonary exercise testing on a cycle ergometer.
- Handgrip strength (in N) [1 hour after inclusion in study]
Measured by a handheld dynamometer.
- Handgrip rate of force development (in N/s) [1 hour after inclusion in study]
Measured by a handheld dynamometer.
- Macrovascular flow-mediated dilation at rest (in %) [0.5 hours after inclusion in study]
Measured by ultrasound.
- Microvascular flow-mediated dilation at rest (in %) [2 to 14 days after inclusion in study]
Measured by retinal vessel analysis.
- Fatigue Assessment Scale (FAS) score [2 to 14 days after inclusion in study]
Scores range from 5 to 50 with higher scores indicating more severe fatigue.
- Score of depression, anxiety, and stress questionnaire (DASS21) [2 to 14 days after inclusion in study]
Scores range from 0 to 63 with higher scores indicating worse mental health.
- Health distance [Calculated during statistical analysis]
The statistical (Mahalanobis) distance (health distance) is a composite measure of various health biomarkers
- Cerebral oxygenation at peak exercise (in %) [1.5 hours after inclusion in study]
Measured using functional near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
Exclusion Criteria:
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel | Basel | BS | Switzerland | 4052 |
Sponsors and Collaborators
- Arno Schmidt-Trucksäss
Investigators
- Principal Investigator: Arno Schmidt-Trucksäss, Prof., Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EKNZ 2021-01039