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Completed

NCT Number: NCT04647734

The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19

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).

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Key information

Conditions

COVID-19, SARS-CoV2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Behavioral

12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week

Standard Care

Behavioral

standard care after discharge from hospital (control group)

Primary outcomes

  1. Change in left ventricular mass

    Time frame: Through study completion, an average of 12 months

    measured by MRI scan

  2. Change in right ventricular volume

    Time frame: Through study completion, an average of 12 months

    measured by MRI scan

Secondary outcomes

  1. Stroke volume

    Time frame: Through study completion, an average of 12 months

    Structural cardiac parameter: measured by MRI scan and echocardiography

  2. end-diastolic volume

    Time frame: Through study completion, an average of 12 months

    Structural cardiac parameter: measured by MRI scan and echocardiography

  3. IVS thickness (intact ventricular septum)

    Time frame: Through study completion, an average of 12 months

    Structural cardiac parameter: measured by MRI scan and echocardiography

  4. LVID (left ventricular internal dimensions)

    Time frame: Through study completion, an average of 12 months

    Structural cardiac parameter: measured by MRI scan and echocardiography

  5. PWT (posterior wall thickness)

    Time frame: Through study completion, an average of 12 months

    Structural cardiac parameter: measured by MRI scan and echocardiography

  6. LAVI (left atrial volume index)

    Time frame: Through study completion, an average of 12 months

    Structural cardiac parameter: measured by MRI scan and echocardiography

  7. LVEF

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  8. Global longitudinal strain

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  9. E/A ratio

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  10. E´

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  11. RV volumes

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  12. RVEF

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  13. TAPSE

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  14. Change in maximal tricuspid regurgitation velocity and pressure gradient

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  15. RV s´

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  16. Peak E velocity

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  17. Peak A velocity

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  18. Septal e´

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  19. Lateral e´

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  20. E/e´ septal

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  21. E/e´ lateral

    Time frame: Through study completion, an average of 12 months

    Functional cardiac parameters: measured by MRI scan and echocardiography

  22. Cardiac inflammation

    Time frame: Through study completion, an average of 12 months

    measured with gadolinium and MRI scan

  23. Vascular dysfunction

    Time frame: Through study completion, an average of 12 months

    measured with gadolinium and MRI scan

  24. Extracellular volume

    Time frame: Through study completion, an average of 12 months

    measured with gadolinium and MRI scan

  25. Diffuse fibrotic changes

    Time frame: Through study completion, an average of 12 months

    measured with gadolinium and MRI scan

  26. Blood and plasma volume

    Time frame: Through study completion, an average of 12 months

    changes

  27. Body composition analysis measured with DXA

    Time frame: Through study completion, an average of 12 months

    easuring Lean mass, Fat mass and BMD

  28. Cardiorespiratory fitness

    Time frame: Through study completion, an average of 12 months

    Measured with an incremental VO2 protocol on exercise bike

  29. Dynamic spirometri

    Time frame: Through study completion, an average of 12 months

    Pulmonary function testing

  30. Whole body plethymography

    Time frame: Through study completion, an average of 12 months

    Pulmonary function testing

  31. Diffusion capacity

    Time frame: Through study completion, an average of 12 months

    Pulmonary function testing

  32. Oral glucose tolerance test

    Time frame: 2 hours at baseline and same after intervention

    75g of glucose taken while fasting

  33. Continuous glucose monitoring

    Time frame: 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.

  34. Axial accelerometer-based physical activity monitors

    Time frame: 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

  35. Blood samples analysed for markers related to low grade inflammation

    Time frame: 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.

  36. Blood samples analysed for markers related to cardiometabolic biomarkers.

    Time frame: 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.

  37. SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status

    Time frame: Through study completion, an average of 12 months

    Questionnaires on quality of life will be filled in on baseline and after the intervention

  38. King´s Brief Interstitial Lung Disease Questionnaire

    Time frame: Through study completion, an average of 12 months

    Questionnaires on quality of life will be filled in on baseline and after the intervention

  39. Post-COVID-19 Functional Status

    Time frame: Through study completion, an average of 12 months

    Questionnaires on quality of life will be filled in on baseline and after the intervention

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2020
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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