Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05659420
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2022-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Intensity Interval Training in Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data', 'description': 'at the end of training, from baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Anaerobic threshold (kg/ml/min)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data', 'description': 'The anaerobic threshold is the highest exercise intensity that you can sustain for a prolonged period without lactate substantially building up in your blood.'}, {'measure': '6minute walk test (meter)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data'}, {'measure': 'maximal heart rate (bpm)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data'}, {'measure': 'systolic blood pressure (mmHg)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data'}, {'measure': 'diastolic blood pressure (mmHg)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data'}, {'measure': 'resting heart rate (bpm)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data'}, {'measure': 'diastolic blood presure (mmHg)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data'}, {'measure': 'depression scale by Patient Health Questionnaire', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data', 'description': 'Patient Health Questionnaire (PHQ; range, 0-27; higher score = severe depression; cut-off score of 5 for minimal depression)'}, {'measure': 'anxiety scale by Generalized Anxiety Disorder Scale', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data', 'description': 'Generalized Anxiety Disorder Scale (GAD; range, 0-21; higher score = severe anxiety; cut-off score of 5 for mild anxiety)'}, {'measure': 'fatigue scale by fatigue severity scale', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data', 'description': 'fatigue severity scale (FSS; range, 9-63; higher score = severe fatigue; cut-off score of 4 for fatigue)'}, {'measure': 'Quality of Life (QoL) questionnaire (MacNew)', 'timeFrame': 'compare baseline data with 12 weeks rehabilitation data', 'description': 'MacNew QoL questionnaire is a measurement tool for patients with cardiac disease that measures physical, emotional, and social functional levels to provide overall QoL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Heart Failure', 'Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of high-intensity interval training and moderate intensity continuous training on cardiopulmonary functions in chronic heart failure.', 'detailedDescription': 'enroll chronic heart failure patients into 3 randomized controlled group\n\n* high intensity interval training\n* moderate intensity continous training\n* control\n\nperform cardica rehab for 12 weeks, compare primary and secondary endpoints between baseline and 12 weeks results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medically stable chronic heart failure\n* NYHA II-III\n* can perform cardiopulmonary exercise test\n* after 3months with proper medication\n* age 30 to 70\n* ejection fraction\\< 40%\n\nExclusion Criteria:\n\n* contraindication to cardiopulmonary exercise test\n* musculoskeletal problem who cannot perform cardiopulmonary exercise test\n* cognition deficit who cannot understand directions\n* severe medial illness'}, 'identificationModule': {'nctId': 'NCT05659420', 'briefTitle': 'High Intensity Interval Training in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': 'The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'InhaUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity interval training', 'interventionNames': ['Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate intensity continous training', 'interventionNames': ['Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor']}], 'interventions': [{'name': 'Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor', 'type': 'BEHAVIORAL', 'description': 'aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor', 'armGroupLabels': ['Control', 'High intensity interval training', 'Moderate intensity continous training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07980', 'city': 'Incheon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung-Lim Joa, M.D.', 'role': 'CONTACT', 'email': 'drjoakl@gmail.com', 'phone': '+82-10-9111-9432'}], 'facility': 'Inha University hospital'}], 'centralContacts': [{'name': 'Kyung-Lim Joa, M.D.', 'role': 'CONTACT', 'email': 'drjoakl@gmail.com', 'phone': '+82-10-9111-9432'}], 'overallOfficials': [{'name': 'Kyung-Lim Joa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of physical medicine and rehabilitation, Inha University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor, M.D. Ph.D', 'investigatorFullName': 'Joa KyungLim', 'investigatorAffiliation': 'Inha University Hospital'}}}}