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

Recruiting

• Conditions: Patients Post-COVID-19; Controls
• Interventions: 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

• Registration Number: NCT05118711
• Lead Sponsor: Arno Schmidt-Trucksäss

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-12
• Study Start: 2023-01-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Muscular strength and balance tests	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
COVID-19 (18 months post-infection)	Cardiorespiratory fitness	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.
COVID-19 (18 months post-infection)	Lung function	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.
Control group	Body composition	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
COVID-19 (18 months post-infection)	Muscular strength and balance tests	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.
Control group	Cardiorespiratory fitness	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
Control group	Physical activity	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
COVID-19 (18 months post-infection)	Micro- and macrovascular endothelial function and cardiac function	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.
COVID-19 (18 months post-infection)	Questionnaires	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.
Control group	Questionnaires	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
COVID-19 (18 months post-infection)	Blood sampling and analysis	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.
COVID-19 (18 months post-infection)	Physical activity	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.
COVID-19 (18 months post-infection)	Body composition	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.
Control group	Lung function	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
Control group	Blood sampling and analysis	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.
Control group	Micro- and macrovascular endothelial function and cardiac function	Age-, sex-, and comorbidity-matched (frequency matching), fully vaccinated individuals with no history of symptomatic SARS-CoV-2 infection.

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness (as % of predicted V̇O2max)	1.5 hours after inclusion in study	Measured during cardiopulmonary exercise testing on a cycle ergometer.

Secondary Outcome Measures

Name	Time	Method
Macrovascular flow-mediated dilation at rest (in %)	0.5 hours after inclusion in study	Measured by ultrasound.
Score of depression, anxiety, and stress questionnaire (DASS21)	2 to 14 days after inclusion in study	Scores range from 0 to 63 with higher scores indicating worse mental health.
Muscle oxygenation at peak exercise (in %)	1.5 hours after inclusion in study	Measured using near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Handgrip strength (in N)	1 hour after inclusion in study	Measured by a handheld dynamometer.
Cerebral oxygenation at peak exercise (in %)	1.5 hours after inclusion in study	Measured using functional near-infrared spectroscopy during cardiopulmonary exercise testing on a cycle ergometer.
Forced expiratory volume in 1 s (as % of predicted)	1.5 hours after inclusion in study	Measured during bodyplethysmography.
Forced vital capacity (as % of predicted)	1.5 hours after inclusion in study	Measured during bodyplethysmography.
Diffusion capacity of the lungs (as % of predicted)	1.5 hours after inclusion in study	Measured during bodyplethysmography.
Microvascular flow-mediated dilation at rest (in %)	2 to 14 days after inclusion in study	Measured by retinal vessel analysis.
Total lung capacity (as % of predicted)	1.5 hours after inclusion in study	Measured during bodyplethysmography.
Cardiac output at peak exercise (in mL)	1.5 hours after inclusion in study	Measured non-invasive using the PhysioFlow device during cardiopulmonary exercise testing on a cycle ergometer.
Handgrip rate of force development (in N/s)	1 hour after inclusion in study	Measured by a handheld dynamometer.
Fatigue Assessment Scale (FAS) score	2 to 14 days after inclusion in study	Scores range from 5 to 50 with higher scores indicating more severe fatigue.
Health distance	Calculated during statistical analysis	The statistical (Mahalanobis) distance (health distance) is a composite measure of various health biomarkers

Trial Locations

Locations (1)

Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel; 🇨🇭 Basel, BS, Switzerland