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

NCT05118711 | Unknown

• 1 other identifier: EKNZ 2021-01039
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Post-COVID-19; Controls

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness (as % of predicted V̇O2max)

  Measured during cardiopulmonary exercise testing on a cycle ergometer.

  1.5 hours after inclusion in study

Secondary Outcomes (14)

• 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

• Total lung 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

• Muscle oxygenation at peak exercise (in %)

  1.5 hours after inclusion in study

Study Arms (2)

COVID-19 (18 months post-infection)

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.

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

Control group

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

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

Interventions

Cardiorespiratory fitness DIAGNOSTIC_TEST

Cardiopulmonary exercise testing

COVID-19 (18 months post-infection); Control group

Lung function DIAGNOSTIC_TEST

Body plethysmography

COVID-19 (18 months post-infection); Control group

Muscular strength and balance tests DIAGNOSTIC_TEST

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

COVID-19 (18 months post-infection); Control group

Micro- and macrovascular endothelial function and cardiac function DIAGNOSTIC_TEST

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

COVID-19 (18 months post-infection); Control group

Blood sampling and analysis DIAGNOSTIC_TEST

Blood sampling by venepuncture

COVID-19 (18 months post-infection); Control group

Physical activity DIAGNOSTIC_TEST

Physical activity surveillance using accelerometers

COVID-19 (18 months post-infection); Control group

Questionnaires DIAGNOSTIC_TEST

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

COVID-19 (18 months post-infection); Control group

Body composition DIAGNOSTIC_TEST

Dual-energy x-ray absorptiometry (DXA)

COVID-19 (18 months post-infection); Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arno Schmidt-Trucksäss: lead

Study Sites (1)

Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel

Basel, Canton of Basel-City, 4052, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (total volume 36 mL) will be collected by venipuncture of the cubital fossa, are subsequently centrifuged and the plasma aliquots are frozen at -80°C.

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Cardiorespiratory Fitness; Respiration; Blood Specimen Collection; Exercise; Body Composition

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Physical Fitness; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Motor Activity; Movement; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Study Officials

• Arno Schmidt-Trucksäss, Prof.

  Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arno Schmidt-Trucksäss, Prof.

CONTACT

+41 61 207 47 40; arno.schmidt-trucksaess@unibas.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator and Head of Rehabilitative and Regenerative Sports Medicine, Department of Sport, Exercise and Health

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 12, 2021
• Study Start: January 3, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)