The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
- Conditions
- COVID-19, SARS-CoV2
- Interventions
- Behavioral: Standard careBehavioral: High intensity interval training
- Registration Number
- NCT04647734
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
40 COVID-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. Patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group).
- Detailed Description
40 patients will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, Pulmonary function, VO2max, RM, plasma volume, AX3, CGM, echocardiography, cardiac MRI.
After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, both groups will complete a series of follow-up tests (as baseline testing). A 1-year follow-up experimental day is also planned in order to evaluate fitness, cardiac and pulmonary structure and function.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Age ≥ 40 years
- A laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 6 months after hospital discharge
- ≤10 L oxygen requirement during hospitalization
- Present atrial fibrillation
- Diagnosed with acute myocarditis
- Health conditions that prevent participating in the exercise intervention
- Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)
- Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Standard care This group will be allocated to standard care and therefore no supervised exercise regimen. High intensity interval training High intensity interval training The experimental group will on top of standard care undergo a 12 weeks supervised exercise high intensity interval exercise training on an ergometer bike three times a week for 38 minutes. The specific intervals will be determined from our ongoing pilot study (NCT04549337)
- Primary Outcome Measures
Name Time Method Change in right ventricular volume Through study completion, an average of 12 months measured by MRI scan
Change in left ventricular mass Through study completion, an average of 12 months measured by MRI scan
- Secondary Outcome Measures
Name Time Method LVID (left ventricular internal dimensions) Through study completion, an average of 12 months Structural cardiac parameter: measured by MRI scan and echocardiography
Global longitudinal strain Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
LVEF Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
RVEF Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Septal e´ Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
E/e´ septal Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Body composition analysis measured with DXA Through study completion, an average of 12 months easuring Lean mass, Fat mass and BMD
Blood samples analysed for markers related to cardiometabolic biomarkers. Through study completion, an average of 12 months Including total troponins, D-dimer, creatinine kinase, total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, glycated haemoglobin, fasting insulin, fasting plasma glucose, pro-brain natriuretic peptide, haematology, electrolytes and liver and renal status.
Following an overnight fast (10 hours), blood samples, are collected and processed by a trained laboratory technician and analysed according to standard procedures. Plasma is stored at - 80 °C prior to analysis.E/A ratio Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Peak A velocity Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Lateral e´ Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Extracellular volume Through study completion, an average of 12 months measured with gadolinium and MRI scan
Blood and plasma volume Through study completion, an average of 12 months changes
PWT (posterior wall thickness) Through study completion, an average of 12 months Structural cardiac parameter: measured by MRI scan and echocardiography
E´ Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Change in maximal tricuspid regurgitation velocity and pressure gradient Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
RV s´ Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Cardiorespiratory fitness Through study completion, an average of 12 months Measured with an incremental VO2 protocol on exercise bike
Dynamic spirometri Through study completion, an average of 12 months Pulmonary function testing
Whole body plethymography Through study completion, an average of 12 months Pulmonary function testing
Continuous glucose monitoring 3 days at baseline and same after intervention Three days of continuous glucose monitoring (CGM) is performed using enzyme-coated electrodes (iPro MMT- 7745WW; Medtronic, Northridge, CA, USA) placed subcutaneously in the abdominal wall. For calibration of the CGM system, finger-prick blood glucose measurements are performed by the participant four times daily.
Axial accelerometer-based physical activity monitors 4 days at baseline and same after intervention Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 4-day period
SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status Through study completion, an average of 12 months Questionnaires on quality of life will be filled in on baseline and after the intervention
King´s Brief Interstitial Lung Disease Questionnaire Through study completion, an average of 12 months Questionnaires on quality of life will be filled in on baseline and after the intervention
RV volumes Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
TAPSE Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Peak E velocity Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Cardiac inflammation Through study completion, an average of 12 months measured with gadolinium and MRI scan
Vascular dysfunction Through study completion, an average of 12 months measured with gadolinium and MRI scan
Diffusion capacity Through study completion, an average of 12 months Pulmonary function testing
Oral glucose tolerance test 2 hours at baseline and same after intervention 75g of glucose taken while fasting
Blood samples analysed for markers related to low grade inflammation Through study completion, an average of 12 months Including high-sensitivity C-reactive protein, tumour necrosis factor-α, IL-1RA, interferon-γ and interleukins (IL-6, IL-10 and others)
Following an overnight fast (10 hours), blood samples, are collected and processed by a trained laboratory technician and analysed according to standard procedures. Plasma is stored at - 80 °C prior to analysis.Post-COVID-19 Functional Status Through study completion, an average of 12 months Questionnaires on quality of life will be filled in on baseline and after the intervention
Stroke volume Through study completion, an average of 12 months Structural cardiac parameter: measured by MRI scan and echocardiography
end-diastolic volume Through study completion, an average of 12 months Structural cardiac parameter: measured by MRI scan and echocardiography
IVS thickness (intact ventricular septum) Through study completion, an average of 12 months Structural cardiac parameter: measured by MRI scan and echocardiography
LAVI (left atrial volume index) Through study completion, an average of 12 months Structural cardiac parameter: measured by MRI scan and echocardiography
E/e´ lateral Through study completion, an average of 12 months Functional cardiac parameters: measured by MRI scan and echocardiography
Diffuse fibrotic changes Through study completion, an average of 12 months measured with gadolinium and MRI scan
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark