Sequelae of COVID-19 With Focus on Exercise Capacity and Underlying Mechanisms

Controls Clinical Trial

— COR-PHYS  

Official title:

COVID-19 Severity, Long-term Consequences for Exercise Capacity and Link to Associated Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118711
• Other study ID #: EKNZ 2021-01039
• Status: Recruiting
• Start date: January 3, 2023
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: University of Basel
• Contact: Arno Schmidt-Trucksäss, Prof.
• Phone: +41 61 207 47 40
• Email: arno.schmidt-trucksaess[@]unibas.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Controls
• COVID-19

Intervention

Diagnostic Test:
• Cardiorespiratory fitness
Cardiopulmonary exercise testing
• Lung function
Body plethysmography
• Muscular strength and balance tests
Handgrip strength test, mid-thigh pull test and standing balance test in static tandem stance
• Micro- and macrovascular endothelial function and cardiac function
Measurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography
• Blood sampling and analysis
Blood sampling by venepuncture
• Physical activity
Physical activity surveillance using accelerometers
• 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
• Body composition
Dual-energy x-ray absorptiometry (DXA)

Locations

Country	Name	City	State
Switzerland	Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
Arno Schmidt-Trucksäss

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness (as % of predicted V?O2max)	Measured during cardiopulmonary exercise testing on a cycle ergometer.	1.5 hours after inclusion in study
Secondary	Forced expiratory volume in 1 s (as % of predicted)	Measured during bodyplethysmography.	1.5 hours after inclusion in study
Secondary	Forced vital capacity (as % of predicted)	Measured during bodyplethysmography.	1.5 hours after inclusion in study
Secondary	Total lung capacity (as % of predicted)	Measured during bodyplethysmography.	1.5 hours after inclusion in study
Secondary	Diffusion capacity of the lungs (as % of predicted)	Measured during bodyplethysmography.	1.5 hours after inclusion in study
Secondary	Muscle oxygenation at peak exercise (in %)	Measured using near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.	1.5 hours after inclusion in study
Secondary	Cardiac output at peak exercise (in mL)	Measured non-invasive using the PhysioFlow device during cardiopulmonary exercise testing on a cycle ergometer.	1.5 hours after inclusion in study
Secondary	Handgrip strength (in N)	Measured by a handheld dynamometer.	1 hour after inclusion in study
Secondary	Handgrip rate of force development (in N/s)	Measured by a handheld dynamometer.	1 hour after inclusion in study
Secondary	Macrovascular flow-mediated dilation at rest (in %)	Measured by ultrasound.	0.5 hours after inclusion in study
Secondary	Microvascular flow-mediated dilation at rest (in %)	Measured by retinal vessel analysis.	2 to 14 days after inclusion in study
Secondary	Fatigue Assessment Scale (FAS) score	Scores range from 5 to 50 with higher scores indicating more severe fatigue.	2 to 14 days after inclusion in study
Secondary	Score of depression, anxiety, and stress questionnaire (DASS21)	Scores range from 0 to 63 with higher scores indicating worse mental health.	2 to 14 days after inclusion in study
Secondary	Health distance	The statistical (Mahalanobis) distance (health distance) is a composite measure of various health biomarkers	Calculated during statistical analysis
Secondary	Cerebral oxygenation at peak exercise (in %)	Measured using functional near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.	1.5 hours after inclusion in study