Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05391620
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2022-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'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': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lactate', 'timeFrame': 'within 2 minutes after TR training session on day 1', 'description': 'mmol/l'}, {'measure': 'change in Testosterone', 'timeFrame': 'within 2 minutes after TR training session on day 1', 'description': 'nmol/l'}, {'measure': 'change Glucocorticoid Cortisol', 'timeFrame': 'within 2 minutes after TR training session on day 1', 'description': 'nmol/l'}, {'measure': 'change in Growth Hormone', 'timeFrame': 'within 2 minutes after TR training session on day 1', 'description': 'ng/ml'}, {'measure': 'change in ph', 'timeFrame': 'within 2 minutes after TR training session on day 1', 'description': 'venoust'}, {'measure': 'change PCO2 venoust', 'timeFrame': 'within 2 minutes after TR training session on day 1', 'description': 'mm Hg'}], 'secondaryOutcomes': [{'measure': 'Borg scale', 'timeFrame': 'within 4 minutes after TR training session on day 1', 'description': 'Borg Rating of Perceived Exertion - Borg modified (0 = no exertion at all -10 maximal exertion)'}, {'measure': 'Pleasure of the session scale', 'timeFrame': 'within 4 minutes after TR training session on day 1', 'description': '0 = worse 10 = better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac rehabilition', 'exercise therapy', 'metabolic stress'], 'conditions': ['Heart Failure', 'Resistance Training', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '35394146', 'type': 'BACKGROUND', 'citation': 'Mang ZA, Realzola RA, Ducharme J, Bellissimo GF, Beam JR, Mermier C, de Castro Magalhaes F, Kravitz L, Amorim FT. The effect of repetition tempo on cardiovascular and metabolic stress when time under tension is matched during lower body exercise. Eur J Appl Physiol. 2022 Jun;122(6):1485-1495. doi: 10.1007/s00421-022-04941-3. Epub 2022 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'The study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population.\n\n3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). This method is compare to 3X9 method, 3 series of 9 repetitions with inter-set (1min).The training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of \\~ 70% of one repetition maximal (1RM).\n\nBefore these trainings all subject perform HIIT on bicycles (2 min high intensity (80% Wmax) and 2 min low intensity (50% Wmax) during 30 minutes.\n\nThe investigators collect blood sample before exercice, after HIIT and after RT.\n\nIt is randomized cross-over study.', 'detailedDescription': 'The subjects come on two different days minimum 2 days and maximum 10 days between the two tests. They were instructed to avoid exercise the day before they participated in the study.\n\nThe investigators collect blood 2 minutes after endurance training (HIIT) and 2 min after RT training.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Coronary artery diseases\n* Heart failure with reduced ejection fraction\n\nExclusion Criteria:\n\n* angina\n* acutely decompensated heart failure\n* electrocardiographic evidence of ischemia\n* significant valvular disease\n* orthopedic/neurologic disorders that limited exercise'}, 'identificationModule': {'nctId': 'NCT05391620', 'briefTitle': 'The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Université Libre de Bruxelles'}, 'officialTitle': 'Acute Effects of the 3/7 Method and 3X9 Method in Resistance Training on Testosterone, Glucocorticoid Cortisol, Growth Hormone and Lactate in Heart Failure and Coronary Artery Disease During Cardiac Rehabilitation', 'orgStudyIdInfo': {'id': '2020276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAD group', 'description': 'Coronary artery diseases', 'interventionNames': ['Other: Cardiac rehabilitation with 3/7 method', 'Other: Cardiac rehabilitation with 3X9 method']}, {'type': 'EXPERIMENTAL', 'label': 'HFrEF group', 'description': 'Heart Failure with reduced Ejection Fraction', 'interventionNames': ['Other: Cardiac rehabilitation with 3/7 method', 'Other: Cardiac rehabilitation with 3X9 method']}], 'interventions': [{'name': 'Cardiac rehabilitation with 3/7 method', 'type': 'OTHER', 'otherNames': ['3/7 method'], 'description': 'HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3/7 method 3 rep (15 sec of rest), 4 rep (15 sec), 5 rep (15 sec), 6 rep (15 sec), 7 rep. (total volume : 25 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension.\n\n1 minute between each machine is planned.', 'armGroupLabels': ['CAD group', 'HFrEF group']}, {'name': 'Cardiac rehabilitation with 3X9 method', 'type': 'OTHER', 'otherNames': ['3X9 method'], 'description': 'HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3X9 method 9 rep 1 minute of rest, 9 rep (1 min) and 9 rep (total volume : 27 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension.\n\n1 minute between each machine is planned', 'armGroupLabels': ['CAD group', 'HFrEF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Philippe van de borne, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexis Gillet', 'investigatorAffiliation': 'Université Libre de Bruxelles'}}}}