COVID-19, SARS-CoV2 Clinical Trial
Official title:
The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
| Verified date | June 2022 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | February 10, 2022 |
| Est. primary completion date | February 1, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Rigshospitalet | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in left ventricular mass | measured by MRI scan | Through study completion, an average of 12 months | |
| Primary | Change in right ventricular volume | measured by MRI scan | Through study completion, an average of 12 months | |
| Secondary | Stroke volume | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | end-diastolic volume | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | IVS thickness (intact ventricular septum) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | LVID (left ventricular internal dimensions) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | PWT (posterior wall thickness) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | LAVI (left atrial volume index) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | LVEF | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Global longitudinal strain | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | E/A ratio | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | E´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | RV volumes | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | RVEF | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | TAPSE | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Change in maximal tricuspid regurgitation velocity and pressure gradient | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | RV s´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Peak E velocity | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Peak A velocity | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Septal e´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Lateral e´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | E/e´ septal | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | E/e´ lateral | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months | |
| Secondary | Cardiac inflammation | measured with gadolinium and MRI scan | Through study completion, an average of 12 months | |
| Secondary | Vascular dysfunction | measured with gadolinium and MRI scan | Through study completion, an average of 12 months | |
| Secondary | Extracellular volume | measured with gadolinium and MRI scan | Through study completion, an average of 12 months | |
| Secondary | Diffuse fibrotic changes | measured with gadolinium and MRI scan | Through study completion, an average of 12 months | |
| Secondary | Blood and plasma volume | changes | Through study completion, an average of 12 months | |
| Secondary | Body composition analysis measured with DXA | easuring Lean mass, Fat mass and BMD | Through study completion, an average of 12 months | |
| Secondary | Cardiorespiratory fitness | Measured with an incremental VO2 protocol on exercise bike | Through study completion, an average of 12 months | |
| Secondary | Dynamic spirometri | Pulmonary function testing | Through study completion, an average of 12 months | |
| Secondary | Whole body plethymography | Pulmonary function testing | Through study completion, an average of 12 months | |
| Secondary | Diffusion capacity | Pulmonary function testing | Through study completion, an average of 12 months | |
| Secondary | Oral glucose tolerance test | 75g of glucose taken while fasting | 2 hours at baseline and same after intervention | |
| Secondary | Continuous glucose monitoring | 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. | 3 days at baseline and same after intervention | |
| Secondary | Axial accelerometer-based physical activity monitors | Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 4-day period | 4 days at baseline and same after intervention | |
| Secondary | Blood samples analysed for markers related to low grade inflammation | Including high-sensitivity C-reactive protein, tumour necrosis factor-a, IL-1RA, interferon-? 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. |
Through study completion, an average of 12 months | |
| Secondary | Blood samples analysed for markers related to cardiometabolic biomarkers. | 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. |
Through study completion, an average of 12 months | |
| Secondary | SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status | Questionnaires on quality of life will be filled in on baseline and after the intervention | Through study completion, an average of 12 months | |
| Secondary | King´s Brief Interstitial Lung Disease Questionnaire | Questionnaires on quality of life will be filled in on baseline and after the intervention | Through study completion, an average of 12 months | |
| Secondary | Post-COVID-19 Functional Status | Questionnaires on quality of life will be filled in on baseline and after the intervention | Through study completion, an average of 12 months |