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

Arno Schmidt-Trucksäss1 site in 1 country128 target enrollmentJanuary 3, 2023

ConditionsPatients Post-COVID-19 Controls

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients Post-COVID-19
Sponsor: Arno Schmidt-Trucksäss
Enrollment: 128
Locations: 1
Primary Endpoint: Cardiorespiratory fitness (as % of predicted V̇O2max)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2023

End Date

March 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Arno Schmidt-Trucksäss

Responsible Party

Sponsor Investigator

Principal Investigator

Arno Schmidt-Trucksäss

Sponsor-Investigator and Head of Rehabilitative and Regenerative Sports Medicine, Department of Sport, Exercise and Health

University of Basel

Eligibility 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)

Outcomes

Primary Outcomes

Cardiorespiratory fitness (as % of predicted V̇O2max)

Time Frame: 1.5 hours after inclusion in study

Measured during cardiopulmonary exercise testing on a cycle ergometer.

Secondary Outcomes

Handgrip strength (in N)(1 hour after inclusion in study)
Macrovascular flow-mediated dilation at rest (in %)(0.5 hours after inclusion in study)
Cerebral oxygenation at peak exercise (in %)(1.5 hours after inclusion in study)
Forced expiratory volume in 1 s (as % of predicted)(1.5 hours after inclusion in study)
Forced vital capacity (as % of predicted)(1.5 hours after inclusion in study)
Diffusion capacity of the lungs (as % of predicted)(1.5 hours after inclusion in study)
Microvascular flow-mediated dilation at rest (in %)(2 to 14 days after inclusion in study)
Muscle oxygenation at peak exercise (in %)(1.5 hours after inclusion in study)
Total lung capacity (as % of predicted)(1.5 hours after inclusion in study)
Cardiac output at peak exercise (in mL)(1.5 hours after inclusion in study)
Handgrip rate of force development (in N/s)(1 hour after inclusion in study)
Fatigue Assessment Scale (FAS) score(2 to 14 days after inclusion in study)
Health distance(Calculated during statistical analysis)
Score of depression, anxiety, and stress questionnaire (DASS21)(2 to 14 days after inclusion in study)