Clinical trial NCT04647734: The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
Official title: The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19, SARS-CoV2
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in left ventricular mass
timeFrame: Through study completion, an average of 12 months
measure: Change in right ventricular volume
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Stroke volume
timeFrame: Through study completion, an average of 12 months
measure: end-diastolic volume
timeFrame: Through study completion, an average of 12 months
measure: IVS thickness (intact ventricular septum)
timeFrame: Through study completion, an average of 12 months
measure: LVID (left ventricular internal dimensions)
timeFrame: Through study completion, an average of 12 months
measure: PWT (posterior wall thickness)
timeFrame: Through study completion, an average of 12 months
measure: LAVI (left atrial volume index)
timeFrame: Through study completion, an average of 12 months
measure: LVEF
timeFrame: Through study completion, an average of 12 months
measure: Global longitudinal strain
timeFrame: Through study completion, an average of 12 months
measure: E/A ratio
timeFrame: Through study completion, an average of 12 months
measure: E´
timeFrame: Through study completion, an average of 12 months
measure: RV volumes
timeFrame: Through study completion, an average of 12 months
measure: RVEF
timeFrame: Through study completion, an average of 12 months
measure: TAPSE
timeFrame: Through study completion, an average of 12 months
measure: Change in maximal tricuspid regurgitation velocity and pressure gradient
timeFrame: Through study completion, an average of 12 months
measure: RV s´
timeFrame: Through study completion, an average of 12 months
measure: Peak E velocity
timeFrame: Through study completion, an average of 12 months
measure: Peak A velocity
timeFrame: Through study completion, an average of 12 months
measure: Septal e´
timeFrame: Through study completion, an average of 12 months
measure: Lateral e´
timeFrame: Through study completion, an average of 12 months
measure: E/e´ septal
timeFrame: Through study completion, an average of 12 months
measure: E/e´ lateral
timeFrame: Through study completion, an average of 12 months
measure: Cardiac inflammation
timeFrame: Through study completion, an average of 12 months
measure: Vascular dysfunction
timeFrame: Through study completion, an average of 12 months
measure: Extracellular volume
timeFrame: Through study completion, an average of 12 months
measure: Diffuse fibrotic changes
timeFrame: Through study completion, an average of 12 months
measure: Blood and plasma volume
timeFrame: Through study completion, an average of 12 months
measure: Body composition analysis measured with DXA
timeFrame: Through study completion, an average of 12 months
measure: Cardiorespiratory fitness
timeFrame: Through study completion, an average of 12 months
measure: Dynamic spirometri
timeFrame: Through study completion, an average of 12 months
measure: Whole body plethymography
timeFrame: Through study completion, an average of 12 months
measure: Diffusion capacity
timeFrame: Through study completion, an average of 12 months
measure: Oral glucose tolerance test
timeFrame: 2 hours at baseline and same after intervention
measure: Continuous glucose monitoring
timeFrame: 3 days at baseline and same after intervention
measure: Axial accelerometer-based physical activity monitors
timeFrame: 4 days at baseline and same after intervention
measure: Blood samples analysed for markers related to low grade inflammation
timeFrame: Through study completion, an average of 12 months
measure: Blood samples analysed for markers related to cardiometabolic biomarkers.
timeFrame: Through study completion, an average of 12 months
measure: SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status
timeFrame: Through study completion, an average of 12 months
measure: King´s Brief Interstitial Lung Disease Questionnaire
timeFrame: Through study completion, an average of 12 months
measure: Post-COVID-19 Functional Status
timeFrame: Through study completion, an average of 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Center for Physical Activity Research, Rigshospitalet
name: Regitse Christensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.