Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity interval training | Experimental | 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) |
|
| Control group | Active Comparator | This group will be allocated to standard care and therefore no supervised exercise regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity interval training | Behavioral | 12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular mass | measured by MRI scan | Through study completion, an average of 12 months |
| Change in right ventricular volume | measured by MRI scan | Through study completion, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke volume | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| end-diastolic volume | Structural cardiac parameter: measured by MRI scan and echocardiography |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Regitse Christensen, MD, PhD | Center for Physical Activity Research, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34794987 | Derived | Rasmussen IE, Foged F, Bjorn Budde J, Rasmussen RS, Rasmussen V, Lyngbaek M, Jonck S, Krogh-Madsen R, Lindegaard B, Ried-Larsen M, Jorgensen PG, Lund MAV, Kober L, Vejlstrup N, Pedersen BK, Berg RMG, Christensen RH. Protective potential of high-intensity interval training on cardiac structure and function after COVID-19: protocol and statistical analysis plan for an investigator-blinded randomised controlled trial. BMJ Open. 2021 Nov 18;11(11):e048281. doi: 10.1136/bmjopen-2020-048281. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care | Behavioral | standard care after discharge from hospital (control group) |
|
| Through study completion, an average of 12 months |
| IVS thickness (intact ventricular septum) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| LVID (left ventricular internal dimensions) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| PWT (posterior wall thickness) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| LAVI (left atrial volume index) | Structural cardiac parameter: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| LVEF | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| Global longitudinal strain | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| E/A ratio | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| E´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| RV volumes | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| RVEF | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| TAPSE | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| 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 |
| RV s´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| Peak E velocity | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| Peak A velocity | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| Septal e´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| Lateral e´ | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| E/e´ septal | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| E/e´ lateral | Functional cardiac parameters: measured by MRI scan and echocardiography | Through study completion, an average of 12 months |
| Cardiac inflammation | measured with gadolinium and MRI scan | Through study completion, an average of 12 months |
| Vascular dysfunction | measured with gadolinium and MRI scan | Through study completion, an average of 12 months |
| Extracellular volume | measured with gadolinium and MRI scan | Through study completion, an average of 12 months |
| Diffuse fibrotic changes | measured with gadolinium and MRI scan | Through study completion, an average of 12 months |
| Blood and plasma volume | changes | Through study completion, an average of 12 months |
| Body composition analysis measured with DXA | easuring Lean mass, Fat mass and BMD | Through study completion, an average of 12 months |
| Cardiorespiratory fitness | Measured with an incremental VO2 protocol on exercise bike | Through study completion, an average of 12 months |
| Dynamic spirometri | Pulmonary function testing | Through study completion, an average of 12 months |
| Whole body plethymography | Pulmonary function testing | Through study completion, an average of 12 months |
| Diffusion capacity | Pulmonary function testing | Through study completion, an average of 12 months |
| Oral glucose tolerance test | 75g of glucose taken while fasting | 2 hours at baseline and same after intervention |
| 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 |
| 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 |
| Blood samples analysed for markers related to low grade inflammation | 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. | Through study completion, an average of 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |