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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05118711
Acronym
COR-PHYS
Enrollment
128
Registered
2021-11-12
Start date
2023-01-03
Completion date
2024-03-31
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Controls, Patients Post-COVID-19

Keywords

SARS-CoV-2, Coronavirus, Sequelae, Exercise intolerance, Cardiopulmonary exercise testing

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.

Interventions

DIAGNOSTIC_TESTCardiorespiratory fitness

Cardiopulmonary exercise testing

DIAGNOSTIC_TESTLung function

Body plethysmography

DIAGNOSTIC_TESTMuscular strength and balance tests

Handgrip strength test, mid-thigh pull test and standing balance test in static tandem stance

DIAGNOSTIC_TESTMicro- and macrovascular endothelial function and cardiac function

Measurement of flow-mediated dilation, static and dynamic retinal vessel analysis, echocardiography

Blood sampling by venepuncture

DIAGNOSTIC_TESTPhysical activity

Physical activity surveillance using accelerometers

DIAGNOSTIC_TESTQuestionnaires

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_TESTBody composition

Dual-energy x-ray absorptiometry (DXA)

Sponsors

Arno Schmidt-Trucksäss
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory fitness (as % of predicted V̇O2max)1.5 hours after inclusion in studyMeasured during cardiopulmonary exercise testing on a cycle ergometer.

Secondary

MeasureTime frameDescription
Forced vital capacity (as % of predicted)1.5 hours after inclusion in studyMeasured during bodyplethysmography.
Total lung capacity (as % of predicted)1.5 hours after inclusion in studyMeasured during bodyplethysmography.
Diffusion capacity of the lungs (as % of predicted)1.5 hours after inclusion in studyMeasured during bodyplethysmography.
Muscle oxygenation at peak exercise (in %)1.5 hours after inclusion in studyMeasured 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 studyMeasured non-invasive using the PhysioFlow device during cardiopulmonary exercise testing on a cycle ergometer.
Handgrip strength (in N)1 hour after inclusion in studyMeasured by a handheld dynamometer.
Forced expiratory volume in 1 s (as % of predicted)1.5 hours after inclusion in studyMeasured during bodyplethysmography.
Macrovascular flow-mediated dilation at rest (in %)0.5 hours after inclusion in studyMeasured by ultrasound.
Microvascular flow-mediated dilation at rest (in %)2 to 14 days after inclusion in studyMeasured by retinal vessel analysis.
Fatigue Assessment Scale (FAS) score2 to 14 days after inclusion in studyScores 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 studyScores range from 0 to 63 with higher scores indicating worse mental health.
Health distanceCalculated during statistical analysisThe 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 studyMeasured using functional near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Handgrip rate of force development (in N/s)1 hour after inclusion in studyMeasured by a handheld dynamometer.

Countries

Switzerland

Contacts

Primary ContactArno Schmidt-Trucksäss, Prof.
arno.schmidt-trucksaess@unibas.ch+41 61 207 47 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026