An observational study in Patients Post-COVID-19 and Controls, sponsored by Arno Schmidt-Trucksäss. Status unknown at 1 site in Switzerland. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Arno Schmidt-Trucksäss · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 128 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Arno Schmidt-Trucksäss is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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 · 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
Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 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 composition
Cardiopulmonary exercise testing
Body plethysmography
Handgrip strength test, mid-thigh pull test and standing balance test in static tandem stance
Measurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography
Blood sampling by venepuncture
Physical activity surveillance using accelerometers
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
Dual-energy x-ray absorptiometry (DXA)
Cardiorespiratory fitness (as % of predicted V̇O2max)
Measured during cardiopulmonary exercise testing on a cycle ergometer.
Time frame: 1.5 hours after inclusion in study
Forced expiratory volume in 1 s (as % of predicted)
Measured during bodyplethysmography.
Time frame: 1.5 hours after inclusion in study
Forced vital capacity (as % of predicted)
Measured during bodyplethysmography.
Time frame: 1.5 hours after inclusion in study
Total lung capacity (as % of predicted)
Measured during bodyplethysmography.
Time frame: 1.5 hours after inclusion in study
Diffusion capacity of the lungs (as % of predicted)
Measured during bodyplethysmography.
Time frame: 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.
Time frame: 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.
Time frame: 1.5 hours after inclusion in study
Handgrip strength (in N)
Measured by a handheld dynamometer.
Time frame: 1 hour after inclusion in study
Handgrip rate of force development (in N/s)
Measured by a handheld dynamometer.
Time frame: 1 hour after inclusion in study
Macrovascular flow-mediated dilation at rest (in %)
Measured by ultrasound.
Time frame: 0.5 hours after inclusion in study
Microvascular flow-mediated dilation at rest (in %)
Measured by retinal vessel analysis.
Time frame: 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.
Time frame: 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.
Time frame: 2 to 14 days after inclusion in study
Health distance
The statistical (Mahalanobis) distance (health distance) is a composite measure of various health biomarkers
Time frame: Calculated during statistical analysis
Cerebral oxygenation at peak exercise (in %)
Measured using functional near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Time frame: 1.5 hours after inclusion in study
Plan to share: No
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Arno Schmidt-Trucksäss