The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in right ventricular volume
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in right ventricular volume
时间窗: Through study completion, an average of 12 months
measured by MRI scan
Change in left ventricular mass
时间窗: Through study completion, an average of 12 months
measured by MRI scan
次要结局
- LVID (left ventricular internal dimensions)(Through study completion, an average of 12 months)
- Global longitudinal strain(Through study completion, an average of 12 months)
- Stroke volume(Through study completion, an average of 12 months)
- end-diastolic volume(Through study completion, an average of 12 months)
- IVS thickness (intact ventricular septum)(Through study completion, an average of 12 months)
- LAVI (left atrial volume index)(Through study completion, an average of 12 months)
- E/e´ lateral(Through study completion, an average of 12 months)
- Diffuse fibrotic changes(Through study completion, an average of 12 months)
- LVEF(Through study completion, an average of 12 months)
- RVEF(Through study completion, an average of 12 months)
- Septal e´(Through study completion, an average of 12 months)
- E/e´ septal(Through study completion, an average of 12 months)
- Body composition analysis measured with DXA(Through study completion, an average of 12 months)
- Blood samples analysed for markers related to cardiometabolic biomarkers.(Through study completion, an average of 12 months)
- E/A ratio(Through study completion, an average of 12 months)
- Peak A velocity(Through study completion, an average of 12 months)
- Lateral e´(Through study completion, an average of 12 months)
- Extracellular volume(Through study completion, an average of 12 months)
- Blood and plasma volume(Through study completion, an average of 12 months)
- PWT (posterior wall thickness)(Through study completion, an average of 12 months)
- E´(Through study completion, an average of 12 months)
- Change in maximal tricuspid regurgitation velocity and pressure gradient(Through study completion, an average of 12 months)
- RV s´(Through study completion, an average of 12 months)
- Cardiorespiratory fitness(Through study completion, an average of 12 months)
- Dynamic spirometri(Through study completion, an average of 12 months)
- Whole body plethymography(Through study completion, an average of 12 months)
- Continuous glucose monitoring(3 days at baseline and same after intervention)
- Axial accelerometer-based physical activity monitors(4 days at baseline and same after intervention)
- SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status(Through study completion, an average of 12 months)
- King´s Brief Interstitial Lung Disease Questionnaire(Through study completion, an average of 12 months)
- RV volumes(Through study completion, an average of 12 months)
- TAPSE(Through study completion, an average of 12 months)
- Peak E velocity(Through study completion, an average of 12 months)
- Cardiac inflammation(Through study completion, an average of 12 months)
- Vascular dysfunction(Through study completion, an average of 12 months)
- Diffusion capacity(Through study completion, an average of 12 months)
- Oral glucose tolerance test(2 hours at baseline and same after intervention)
- Blood samples analysed for markers related to low grade inflammation(Through study completion, an average of 12 months)
- Post-COVID-19 Functional Status(Through study completion, an average of 12 months)
研究者
Regitse Christensen
Principal investigator
Rigshospitalet, Denmark