Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 2:36 PM
Study NCT ID:
NCT04555512
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Effectiveness of Different High-intensity Interval Training Programs in Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiorepiratory fitness', 'timeFrame': 'Pre and post study completion, approximately 12 weeks', 'description': 'Measure as peak oxygen consumption (VO2 peak)'}], 'secondaryOutcomes': [{'measure': 'Change in oxygen uptake response time', 'timeFrame': 'Weekly, over 12 weeks', 'description': 'Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset'}, {'measure': 'Change in locomotor muscle oxygenation', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)'}, {'measure': 'Change in metaboreflex stimulation', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as changes in blood pressure during recovery from exercise'}, {'measure': 'Changes in mechanoreflex stimulation and sensitization', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as changes in blood pressure during recovery from exercise'}, {'measure': 'Change in cardiac function', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as global longitudinal strain by echocardiography at rest and during sub-maximal exercise'}, {'measure': 'Change in body composition', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as fat mass by dual-energy x-ray absorptiometry'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as resting and mean 24-hr blood pressures by ambulatory blood pressure monitor'}, {'measure': 'Change in blood lipids', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides'}, {'measure': 'Change in physical activity', 'timeFrame': 'Pre and post study completion, 12 weeks', 'description': 'Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Rehabilitation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to examine the effect of two different high intensity interval training (HIIT) prescription approaches on improving fitness, heart function, and the ability of the body's muscles to receive oxygen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years and older.\n* English speaking.\n* Able to provide consent.\n* Has a qualifying indication for center-based cardiac rehabilitation that is non-surgical (i.e., Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, and stable angina).\n\nExclusion Criteria:\n\n* Participants referred to cardiac rehabilitation following coronary artery bypass surgery, heart valve repair/replacement, heart transplant, or those with ventricular assist devices.\n* Patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program are not eligible.\n* Patients unable/unwilling to provide informed consent will not be enrolled.\n* Patients identified as having a contraindication to high intensity exercise.'}, 'identificationModule': {'nctId': 'NCT04555512', 'briefTitle': 'A Study to Compare the Effectiveness of Different High-intensity Interval Training Programs in Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Efficacy of Prescription Methods for High-intensity Interval Training in Patients Enrolled in Outpatient Cardiac Rehabilitation', 'orgStudyIdInfo': {'id': '20-005923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-care interval-training group', 'description': 'Subjects will complete a standard interval-training program that remains constant for the entire 12 weeks of cardiac rehabilitation.', 'interventionNames': ['Other: Constant High Intensity Interval Training (CON-HIIT)']}, {'type': 'EXPERIMENTAL', 'label': 'Progressive interval-training group', 'description': 'Subjects will complete an interval-training program during which the number of intervals and the duration of each interval are changed across the 12-week cardiac rehabilitation program.', 'interventionNames': ['Other: Progressive High Intensity Interval Training (PRO-HIIT)']}], 'interventions': [{'name': 'Progressive High Intensity Interval Training (PRO-HIIT)', 'type': 'OTHER', 'description': 'Individual exercise training sessions, involving two weeks of moderate intensity continuous exercise and 10 weeks of interval exercise training. This protocol involves progression of training of 3 stages: 1) six high-intensity intervals (at an RPE of 15-18) of 1-min separated by five low-intensity intervals of 2-min; 2) three high-intensity intervals of 2-min separated by two low-intensity intervals of 4-min, and a further 2-min of low intensity following the last interval before cool-down; and 3) three high-intensity intervals of 3-min separated by two low-intensity intervals of 3-min, and a further 1-min of low intensity following last interval before cool-down.', 'armGroupLabels': ['Progressive interval-training group']}, {'name': 'Constant High Intensity Interval Training (CON-HIIT)', 'type': 'OTHER', 'description': 'Individual exercise training sessions, involving two weeks of moderate intensity continuous exercise and 10 weeks of interval exercise training. This protocol involves a constant protocol of training, including six high-intensity intervals (at an RPE of 15-18) of 1-min separated by five low-intensity intervals of 2-min.', 'armGroupLabels': ['Standard-care interval-training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Jenna-Lee Taylor, PhD', 'role': 'CONTACT', 'email': 'Taylor.Jenna-lee@mayo.edu', 'phone': '(507) 284-1329'}, {'name': 'Amanda R Bonikowske, PhD', 'role': 'CONTACT', 'email': 'bonikowske.amanda@mayo.edu'}], 'overallOfficials': [{'name': 'Amanda R Bonikowske, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amanda R. Bonikowske', 'investigatorAffiliation': 'Mayo Clinic'}}}}