Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-22 @ 11:54 AM
Study NCT ID:
NCT04248894
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2020-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle sympathetic nerve activity (MSNA)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'MSNA is being assessed by microneurography'}, {'measure': 'Change muscle mechanoreceptor sensitivity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The mechanoreceptor sensitivity is being assessed via passive exercise to the leg'}, {'measure': 'Change muscle metaboreceptor sensitivity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.'}, {'measure': 'Change in chemoreceptor sensitivity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Hypoxia via 10% oxygen'}], 'secondaryOutcomes': [{'measure': 'Peripheral vascular function', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Brachial artery flow-mediated dilation is being used to assess the vascular function'}, {'measure': 'Skeletal muscle function', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '32673501', 'type': 'DERIVED', 'citation': 'Sales ARK, Azevedo LF, Silva TOC, Rodrigues AG, Oliveira PA, Jordao CP, Andrade ACM, Urias U, Guimaraes GV, Bocchi EA, Alves MJNN, Hajjar LA, Filho RK, Grunewald ZI, Martinez-Lemus LA, Padilla J, Negrao CE. High-Intensity Interval Training Decreases Muscle Sympathetic Nerve Activity and Improves Peripheral Vascular Function in Patients With Heart Failure With Reduced Ejection Fraction. Circ Heart Fail. 2020 Aug;13(8):e007121. doi: 10.1161/CIRCHEARTFAILURE.120.007121. Epub 2020 Jul 16. No abstract available.'}, {'pmid': '32578441', 'type': 'DERIVED', 'citation': 'Xiao P, Wang C, Li J, Su H, Yang L, Wu P, Lewno MT, Liu J, Wang X. COP9 Signalosome Suppresses RIPK1-RIPK3-Mediated Cardiomyocyte Necroptosis in Mice. Circ Heart Fail. 2020 Aug;13(8):e006996. doi: 10.1161/CIRCHEARTFAILURE.120.006996. Epub 2020 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF).', 'detailedDescription': 'In this study, the investigators are testing the hypothesis that reductions in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF). To test this hypothesis patients with chronic heart failure (30 - 65 years), left ventricular ejection fraction ≤40%, Functional Classes II-III), are being randomized into exercise with HIIT, MICT or no training (NT) three times/week for 12 weeks. Muscle sympathetic nerve activity is assessed by microneurography. Brachial artery flow-mediated dilation (FMD), blood flow and vascular conductance were assessed by ultrasonography. Blood pressure (BP) and heart rate (HR) by are being measured via finger photoplethysmograph and peak oxygen uptake (V̇O2peak) by a cardiopulmonary exercise test on ergometer cycle for leg. Biopsy samples from the lateral vast of the thigh are being collected for analysis of the intracellular mechanisms in the skeletal muscle. Exercise training is being conducted under supervision at the Heart Institute, School of Medicine, University of São Paulo. Both HIIT and MICT are performed on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session is established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point (RCP). The intensity of the HIIT session is established based on the HR and workload levels corresponding to 5% above the RCP. All exercise sessions were performed under the supervision of an exercise physiologist. The patients in the NT group were instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study. All patients are being assessed before (pre) and after (post) both exercise training modes or control, no training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functional Class II to III of New York Heart Association\n* Left ventricular ejection fraction ≤40%\n* Peak oxygen uptake (V̇O2) \\<20 ml•kg-1•min-1\n\nExclusion Criteria:\n\n* Myocardial infarction within three months\n* Unstable angina\n* Acute heart failure\n* Pacemaker\n* Pulmonary disease\n* Chronic renal disease\n* Peripheral neuropathy\n* History of stroke\n* Untreated hypo/hyperthyroidism\n* Body mass index (BMI) \\>30 kg/m2\n* History of smoking'}, 'identificationModule': {'nctId': 'NCT04248894', 'briefTitle': 'Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'The Impact of High-intensity Interval Training Versus Moderate Continuous Training on Neurovascular Control in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'SDC: 4070/14/050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity interval training (HIIT)', 'description': 'High-intensity interval training (HIIT) = the exercise of high intensity perform on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the HIIT session was established based on the HR and workload levels corresponding to 5% above the respiratory compensation point.', 'interventionNames': ['Other: Exercise training of High Intensity']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate-intensity continuous training (MICT)', 'description': 'Moderate-intensity continuous training (MICT) = the exercise of moderate intensity perform on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session was established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point', 'interventionNames': ['Other: Exercise training of Moderate Intensity']}, {'type': 'SHAM_COMPARATOR', 'label': 'No training', 'description': 'The patients are instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study.', 'interventionNames': ['Other: Untraining']}], 'interventions': [{'name': 'Exercise training of High Intensity', 'type': 'OTHER', 'otherNames': ['Physical exercise'], 'description': 'High intensity', 'armGroupLabels': ['High-intensity interval training (HIIT)']}, {'name': 'Exercise training of Moderate Intensity', 'type': 'OTHER', 'description': 'Moderate intensity', 'armGroupLabels': ['Moderate-intensity continuous training (MICT)']}, {'name': 'Untraining', 'type': 'OTHER', 'description': 'Sedentary', 'armGroupLabels': ['No training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'Cerqueira Cesar', 'country': 'Brazil', 'facility': 'Heart Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute (InCor)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Calors Negrao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'aHeart Institute, University of São Paulo Medical School, São Paulo, Brazil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}