Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT01493193
Status:
COMPLETED
Last Update Posted:
2013-08-01
First Post:
2011-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Endurance Training Protocols in Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076663', 'term': 'Endurance Training'}, {'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-31', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual maximum power output in watt (Pmax)', 'timeFrame': '6 weeks', 'description': 'Change of individual maximum power output in watt (Pmax) on a bicycle ergometer after the training intervention of controlled physical activity within 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Power output in watt at lactate threshold of 2 and 4 mmol/l', 'timeFrame': '6 weeks', 'description': 'Change of power output in watt at lactate thresholds at 2 and 4 mmol/l'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19351942', 'type': 'BACKGROUND', 'citation': "Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457."}, {'pmid': '9355890', 'type': 'BACKGROUND', 'citation': 'Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kalberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kubler W. Attenuated progression of coronary artery disease after 6 years of multifactorial risk intervention: role of physical exercise. Circulation. 1997 Oct 21;96(8):2534-41. doi: 10.1161/01.cir.96.8.2534.'}, {'pmid': '19351941', 'type': 'BACKGROUND', 'citation': "O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454."}, {'pmid': '17414804', 'type': 'BACKGROUND', 'citation': 'Helgerud J, Hoydal K, Wang E, Karlsen T, Berg P, Bjerkaas M, Simonsen T, Helgesen C, Hjorth N, Bach R, Hoff J. Aerobic high-intensity intervals improve VO2max more than moderate training. Med Sci Sports Exerc. 2007 Apr;39(4):665-71. doi: 10.1249/mss.0b013e3180304570.'}, {'pmid': '17548726', 'type': 'BACKGROUND', 'citation': 'Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.'}], 'seeAlsoLinks': [{'url': 'http://www.salk.at/sportmedizin.html', 'label': 'Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg, Austria'}, {'url': 'http://www.salk.at', 'label': 'Salzburg Regional Hospital'}]}, 'descriptionModule': {'briefSummary': 'It is the aim of the study to compare the effects of 6 weeks of either high-intensity interval training (HIT; carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.\n\nThe three exercise arms (isocaloric) are composed as follows:\n\nEndurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min; Pyramids (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.\n\nAll protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRpeak.\n\nPrimary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate thresholds at 2 and 4 mmol/l.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAt least one of the following diagnoses within the previous 3 months:\n\n* acute coronary syndrome (STEMI)\n* acute coronary syndrome (NSTEMI)\n* aortocoronary bypass surgery\n* PCI\n* stable coronary heart disease\n\nExclusion Criteria:\n\n* Unstable angina pectoris\n* Heart failure (NYHA IV)\n* Acute endomyocarditis or other acute infections\n* Pulmonary artery embolism or phlebothrombosis within the previous 6 months\n* Hemodynamically unstable arrhythmia\n* Hypertrophic cardiomyopathy\n* participation in another study within the previous 6 months\n* Medical conditions which prevent patients from complying with the exercise program'}, 'identificationModule': {'nctId': 'NCT01493193', 'briefTitle': 'Different Endurance Training Protocols in Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Paracelsus Medical University'}, 'officialTitle': 'Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients', 'orgStudyIdInfo': {'id': 'UISM-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endurance training with constant work load', 'interventionNames': ['Other: Endurance training with constant work load']}, {'type': 'EXPERIMENTAL', 'label': 'Pyramid-Training', 'interventionNames': ['Other: Pyramid-Training']}, {'type': 'EXPERIMENTAL', 'label': 'High-intensity interval training', 'interventionNames': ['Other: High-intensity interval training']}], 'interventions': [{'name': 'Endurance training with constant work load', 'type': 'OTHER', 'description': 'Endurance training with constant work load(n=15): 31min at 65-75% HRmax', 'armGroupLabels': ['Endurance training with constant work load']}, {'name': 'Pyramid-Training', 'type': 'OTHER', 'description': 'Pyramid-Training (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.', 'armGroupLabels': ['Pyramid-Training']}, {'name': 'High-intensity interval training', 'type': 'OTHER', 'description': 'HIT (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min', 'armGroupLabels': ['High-intensity interval training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Josef Niebauer, MD, PhD, MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Paracelsus Medical University'}, {'name': 'Marcus Tschentscher, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paracelsus Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primar', 'investigatorFullName': 'Prof. Josef Niebauer M.D., Ph.D., MBA', 'investigatorAffiliation': 'Paracelsus Medical University'}}}}