Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 4:43 PM
Study NCT ID:
NCT04647734
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2020-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2020-11-27', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in left ventricular mass', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'measured by MRI scan'}, {'measure': 'Change in right ventricular volume', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'measured by MRI scan'}], 'secondaryOutcomes': [{'measure': 'Stroke volume', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Structural cardiac parameter: measured by MRI scan and echocardiography'}, {'measure': 'end-diastolic volume', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Structural cardiac parameter: measured by MRI scan and echocardiography'}, {'measure': 'IVS thickness (intact ventricular septum)', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Structural cardiac parameter: measured by MRI scan and echocardiography'}, {'measure': 'LVID (left ventricular internal dimensions)', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Structural cardiac parameter: measured by MRI scan and echocardiography'}, {'measure': 'PWT (posterior wall thickness)', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Structural cardiac parameter: measured by MRI scan and echocardiography'}, {'measure': 'LAVI (left atrial volume index)', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Structural cardiac parameter: measured by MRI scan and echocardiography'}, {'measure': 'LVEF', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Global longitudinal strain', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'E/A ratio', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'E´', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'RV volumes', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'RVEF', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'TAPSE', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Change in maximal tricuspid regurgitation velocity and pressure gradient', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'RV s´', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Peak E velocity', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Peak A velocity', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Septal e´', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Lateral e´', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'E/e´ septal', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'E/e´ lateral', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Functional cardiac parameters: measured by MRI scan and echocardiography'}, {'measure': 'Cardiac inflammation', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'measured with gadolinium and MRI scan'}, {'measure': 'Vascular dysfunction', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'measured with gadolinium and MRI scan'}, {'measure': 'Extracellular volume', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'measured with gadolinium and MRI scan'}, {'measure': 'Diffuse fibrotic changes', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'measured with gadolinium and MRI scan'}, {'measure': 'Blood and plasma volume', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'changes'}, {'measure': 'Body composition analysis measured with DXA', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'easuring Lean mass, Fat mass and BMD'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Measured with an incremental VO2 protocol on exercise bike'}, {'measure': 'Dynamic spirometri', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Pulmonary function testing'}, {'measure': 'Whole body plethymography', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Pulmonary function testing'}, {'measure': 'Diffusion capacity', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Pulmonary function testing'}, {'measure': 'Oral glucose tolerance test', 'timeFrame': '2 hours at baseline and same after intervention', 'description': '75g of glucose taken while fasting'}, {'measure': 'Continuous glucose monitoring', 'timeFrame': '3 days at baseline and same after intervention', 'description': '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.'}, {'measure': 'Axial accelerometer-based physical activity monitors', 'timeFrame': '4 days at baseline and same after intervention', 'description': 'Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 4-day period'}, {'measure': 'Blood samples analysed for markers related to low grade inflammation', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Including high-sensitivity C-reactive protein, tumour necrosis factor-α, IL-1RA, interferon-γ and interleukins (IL-6, IL-10 and others)\n\nFollowing 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.'}, {'measure': 'Blood samples analysed for markers related to cardiometabolic biomarkers.', 'timeFrame': 'Through study completion, an average of 12 months', 'description': '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.\n\nFollowing 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.'}, {'measure': 'SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Questionnaires on quality of life will be filled in on baseline and after the intervention'}, {'measure': 'King´s Brief Interstitial Lung Disease Questionnaire', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Questionnaires on quality of life will be filled in on baseline and after the intervention'}, {'measure': 'Post-COVID-19 Functional Status', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Questionnaires on quality of life will be filled in on baseline and after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19, SARS-CoV2']}, 'referencesModule': {'references': [{'pmid': '34794987', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 40 years\n* 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\n* ≤10 L oxygen requirement during hospitalization\n\nExclusion Criteria:\n\n* Present atrial fibrillation\n* Diagnosed with acute myocarditis\n* Health conditions that prevent participating in the exercise intervention\n* Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)\n* Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.'}, 'identificationModule': {'nctId': 'NCT04647734', 'briefTitle': 'The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19', 'orgStudyIdInfo': {'id': 'H-20033733 v.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity interval training', 'description': '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)', 'interventionNames': ['Behavioral: High intensity interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'This group will be allocated to standard care and therefore no supervised exercise regimen.', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'High intensity interval training', 'type': 'BEHAVIORAL', 'description': '12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week', 'armGroupLabels': ['High intensity interval training']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'standard care after discharge from hospital (control group)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Regitse Christensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Physical Activity Research, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Regitse Christensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}