Sequelae of COVID-19 With Focus on Exercise Capacity and Underlying Mechanisms (COR-PHYS)

Arno Schmidt-Trucksäss

Status: Enrolling

Conditions: Patients Post-COVID-19; Controls

Treatments: Diagnostic Test: Cardiorespiratory fitness; Diagnostic Test: Blood sampling and analysis; Diagnostic Test: Muscular strength and balance tests; Diagnostic Test: Body composition; Diagnostic Test: Lung function; Diagnostic Test: Questionnaires; Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function; Diagnostic Test: Physical activity

Study type: Observational

Funder types: Other

Identifiers

NCT05118711

EKNZ 2021-01039

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

128 participants in 2 patient groups

COVID-19 (18 months post-infection)

Description:

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.

Treatment:

Diagnostic Test: Body composition

Diagnostic Test: Questionnaires

Diagnostic Test: Cardiorespiratory fitness

Diagnostic Test: Blood sampling and analysis

Diagnostic Test: Muscular strength and balance tests

Diagnostic Test: Physical activity

Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function

Diagnostic Test: Lung function

Control group

Description:

Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.

Treatment:

Diagnostic Test: Body composition

Diagnostic Test: Questionnaires

Diagnostic Test: Cardiorespiratory fitness

Diagnostic Test: Blood sampling and analysis

Diagnostic Test: Muscular strength and balance tests

Diagnostic Test: Physical activity

Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function

Diagnostic Test: Lung function