Clinical trial NCT05118711: Sequelae of COVID-19 With Focus on Exercise Capacity and Underlying Mechanisms
Official title: COVID-19 Severity, Long-term Consequences for Exercise Capacity and Link to Associated Mechanisms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Post-COVID-19
Controls
Keywords: SARS-CoV-2
Coronavirus
Sequelae
Exercise intolerance
Cardiopulmonary exercise testing
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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)

Primary outcomes:
measure: Cardiorespiratory fitness (as % of predicted V̇O2max)
timeFrame: 1.5 hours after inclusion in study
Secondary outcomes:
measure: Forced expiratory volume in 1 s (as % of predicted)
timeFrame: 1.5 hours after inclusion in study
measure: Forced vital capacity (as % of predicted)
timeFrame: 1.5 hours after inclusion in study
measure: Total lung capacity (as % of predicted)
timeFrame: 1.5 hours after inclusion in study
measure: Diffusion capacity of the lungs (as % of predicted)
timeFrame: 1.5 hours after inclusion in study
measure: Muscle oxygenation at peak exercise (in %)
timeFrame: 1.5 hours after inclusion in study
measure: Cardiac output at peak exercise (in mL)
timeFrame: 1.5 hours after inclusion in study
measure: Handgrip strength (in N)
timeFrame: 1 hour after inclusion in study
measure: Handgrip rate of force development (in N/s)
timeFrame: 1 hour after inclusion in study
measure: Macrovascular flow-mediated dilation at rest (in %)
timeFrame: 0.5 hours after inclusion in study
measure: Microvascular flow-mediated dilation at rest (in %)
timeFrame: 2 to 14 days after inclusion in study
measure: Fatigue Assessment Scale (FAS) score
timeFrame: 2 to 14 days after inclusion in study
measure: Score of depression, anxiety, and stress questionnaire (DASS21)
timeFrame: 2 to 14 days after inclusion in study
measure: Health distance
timeFrame: Calculated during statistical analysis
measure: Cerebral oxygenation at peak exercise (in %)
timeFrame: 1.5 hours after inclusion in study
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
state: BS
Study officials:
affiliation: Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
name: Arno Schmidt-Trucksäss, Prof.
role: PRINCIPAL_INVESTIGATOR
References: