Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-01-04 @ 10:09 AM
Study NCT ID:
NCT02674659
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'C566337', 'term': 'Hypercholesterolemia, Autosomal Dominant, 3'}], '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': 'D055070', 'term': 'Resistance 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bambangdwiputra@gmail.com', 'phone': '0215684093', 'title': 'Bambang Dwiputra, MD, FIHA', 'organization': 'Harapan Kita National Cardiovascular Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study only investigated selected population of patients (post CABG patients) and cannot explain further the mechanism of reduced PCSK9 level by doing resistance training'}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 2, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'wound infection', 'notes': 'postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'wound infection'}], 'seriousEvents': [{'term': 'Acute heart failure', 'notes': 'acute decompensated heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ADHF'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PCSK-9 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '377.5', 'spread': '118.9', 'groupId': 'OG000'}, {'value': '322.53', 'spread': '107.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method", 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the cardiac rehabilitation program'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '106.3', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '96.2', 'spread': '24.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': 'Body Mass Index is calculated by calculating the measured body weight divided by the height square in measure. We take BMI data after cardiac rehabilitation program in every participant.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High-Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '162.2', 'spread': '32.6', 'groupId': 'OG000'}, {'value': '162.1', 'spread': '35.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglyceride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '145.7', 'spread': '50.2', 'groupId': 'OG000'}, {'value': '139.4', 'spread': '50.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '107.7', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '102.4', 'spread': '22.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "Blood glucose concentration was taken after 10-12-hour fasting. This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '117.3', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '118.8', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '74.8', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'FG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'We initiate this project from February 10th, 2016 until September 23rd, 2016. All the subjects (post coronary artery bypass graft operation) were collected from the National Cardiovascular Center Harapan Kita.', 'preAssignmentDetails': 'There is no specific run-in period for every patient enrolled in this study. If they meet the inclusion criteria, they will be randomly assigned to the intervention or control group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'BG001', 'title': 'Intervention Group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)\n\nresistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.\n\naerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years old', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex : Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Sex : Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Sex : Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '164.5', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '162.9', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '163.7', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.2', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '67.1', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'waist circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97.5', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '95.1', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '96.3', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.2', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '24.6', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '24.9', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cardiovascular risk factor', 'classes': [{'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes Mellitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Dyslipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Family history', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ejection Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52.1', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '50.2', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '121.1', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '125.3', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '123.2', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '76.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '75.7', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Statin therapy', 'classes': [{'title': 'Simvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Simvastatin 10 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Simvastatin 20 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Atorvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Length of stay', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '9.1', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CPB duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81.5', 'spread': '26.4', 'groupId': 'BG000'}, {'value': '81.2', 'spread': '21.3', 'groupId': 'BG001'}, {'value': '81.4', 'spread': '23.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'CABG patients on pump (using CPB machine)'}, {'title': 'Aortic cross clamp duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.9', 'spread': '24.1', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '16.9', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '20.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'CABG patients on pump (using CPB machine)'}, {'title': 'Cardiac Rehabilitation Program Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Frequency 3 times/week', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Frequency 5 times/week', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting Blood Glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '116.5', 'spread': '41.5', 'groupId': 'BG000'}, {'value': '116.6', 'spread': '37.6', 'groupId': 'BG001'}, {'value': '116.6', 'spread': '39.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lipid profile', 'classes': [{'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '161.1', 'spread': '32.4', 'groupId': 'BG000'}, {'value': '160.4', 'spread': '36.5', 'groupId': 'BG001'}, {'value': '160.8', 'spread': '34.5', 'groupId': 'BG002'}]}]}, {'title': 'High Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.9', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '33.7', 'spread': '8.3', 'groupId': 'BG002'}]}]}, {'title': 'Low Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '96.7', 'spread': '30.1', 'groupId': 'BG000'}, {'value': '96.3', 'spread': '30.2', 'groupId': 'BG001'}, {'value': '96.5', 'spread': '30.2', 'groupId': 'BG002'}]}]}, {'title': 'Trigliseride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '172.2', 'spread': '63.2', 'groupId': 'BG000'}, {'value': '171.8', 'spread': '58.7', 'groupId': 'BG001'}, {'value': '172', 'spread': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate Aminotransferase (AST)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.6', 'spread': '16.5', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '26.7', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine Aminotransferase (ALT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.3', 'spread': '23.3', 'groupId': 'BG000'}, {'value': '49.2', 'spread': '24.2', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '23.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Uric acid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '1.03', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.05', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PCSK-9', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '382.4', 'spread': '127.3', 'groupId': 'BG000'}, {'value': '407.04', 'spread': '112.3', 'groupId': 'BG001'}, {'value': '394.7', 'spread': '119.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2016-02-02', 'resultsFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-19', 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCSK-9 Level', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method"}], 'secondaryOutcomes': [{'measure': 'Low Density Lipoprotein', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program"}, {'measure': 'Body Mass Index', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': 'Body Mass Index is calculated by calculating the measured body weight divided by the height square in measure. We take BMI data after cardiac rehabilitation program in every participant.'}, {'measure': 'High-Density Lipoprotein', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program"}, {'measure': 'Total Cholesterol', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program"}, {'measure': 'Triglyceride', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program"}, {'measure': 'Fasting Blood Glucose', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "Blood glucose concentration was taken after 10-12-hour fasting. This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program"}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program"}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)', 'description': "this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resistance training, PCSK9, coronary artery bypass grafting'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '15121495', 'type': 'BACKGROUND', 'citation': 'Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.'}, {'pmid': '21896934', 'type': 'BACKGROUND', 'citation': 'Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6.'}, {'pmid': '23414745', 'type': 'RESULT', 'citation': 'Ghroubi S, Elleuch W, Abid L, Abdenadher M, Kammoun S, Elleuch MH. Effects of a low-intensity dynamic-resistance training protocol using an isokinetic dynamometer on muscular strength and aerobic capacity after coronary artery bypass grafting. Ann Phys Rehabil Med. 2013 Mar;56(2):85-101. doi: 10.1016/j.rehab.2012.10.006. Epub 2012 Dec 7.'}, {'pmid': '23176104', 'type': 'RESULT', 'citation': 'Busch JC, Lillou D, Wittig G, Bartsch P, Willemsen D, Oldridge N, Bjarnason-Wehrens B. Resistance and balance training improves functional capacity in very old participants attending cardiac rehabilitation after coronary bypass surgery. J Am Geriatr Soc. 2012 Dec;60(12):2270-6. doi: 10.1111/jgs.12030. Epub 2012 Nov 23.'}, {'pmid': '26081791', 'type': 'RESULT', 'citation': 'Kamani CH, Gencer B, Montecucco F, Courvoisier D, Vuilleumier N, Meyer P, Mach F. Stairs instead of elevators at the workplace decreases PCSK9 levels in a healthy population. Eur J Clin Invest. 2015 Oct;45(10):1017-24. doi: 10.1111/eci.12480. Epub 2015 Aug 26.'}, {'pmid': '23973703', 'type': 'RESULT', 'citation': 'Urban D, Poss J, Bohm M, Laufs U. Targeting the proprotein convertase subtilisin/kexin type 9 for the treatment of dyslipidemia and atherosclerosis. J Am Coll Cardiol. 2013 Oct 15;62(16):1401-8. doi: 10.1016/j.jacc.2013.07.056. Epub 2013 Aug 21.'}, {'pmid': '18547466', 'type': 'RESULT', 'citation': 'Kim HS, Wu Y, Lin SJ, Deerochanawong C, Zambahari R, Zhao L, Zhang Q, Yan P. Current status of cholesterol goal attainment after statin therapy among patients with hypercholesterolemia in Asian countries and region: the Return on Expenditure Achieved for Lipid Therapy in Asia (REALITY-Asia) study. Curr Med Res Opin. 2008 Jul;24(7):1951-63. doi: 10.1185/03007990802138731. Epub 2008 Jun 10.'}, {'pmid': '23128163', 'type': 'RESULT', 'citation': 'Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.'}, {'pmid': '16554528', 'type': 'RESULT', 'citation': 'Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264-72. doi: 10.1056/NEJMoa054013.'}, {'pmid': '17080197', 'type': 'RESULT', 'citation': 'Lagace TA, Curtis DE, Garuti R, McNutt MC, Park SW, Prather HB, Anderson NN, Ho YK, Hammer RE, Horton JD. Secreted PCSK9 decreases the number of LDL receptors in hepatocytes and in livers of parabiotic mice. J Clin Invest. 2006 Nov;116(11):2995-3005. doi: 10.1172/JCI29383.'}, {'pmid': '17452316', 'type': 'RESULT', 'citation': 'Zhang DW, Lagace TA, Garuti R, Zhao Z, McDonald M, Horton JD, Cohen JC, Hobbs HH. Binding of proprotein convertase subtilisin/kexin type 9 to epidermal growth factor-like repeat A of low density lipoprotein receptor decreases receptor recycling and increases degradation. J Biol Chem. 2007 Jun 22;282(25):18602-18612. doi: 10.1074/jbc.M702027200. Epub 2007 Apr 23.'}, {'pmid': '23862065', 'type': 'RESULT', 'citation': 'Wen S, Jadhav KS, Williamson DL, Rideout TC. Treadmill Exercise Training Modulates Hepatic Cholesterol Metabolism and Circulating PCSK9 Concentration in High-Fat-Fed Mice. J Lipids. 2013;2013:908048. doi: 10.1155/2013/908048. Epub 2013 Jun 19.'}, {'pmid': '20643803', 'type': 'RESULT', 'citation': 'European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.'}, {'pmid': '17881241', 'type': 'RESULT', 'citation': 'Fiorina C, Vizzardi E, Lorusso R, Maggio M, De Cicco G, Nodari S, Faggiano P, Dei Cas L. The 6-min walking test early after cardiac surgery. Reference values and the effects of rehabilitation programme. Eur J Cardiothorac Surg. 2007 Nov;32(5):724-9. doi: 10.1016/j.ejcts.2007.08.013. Epub 2007 Sep 18.'}, {'pmid': '27771273', 'type': 'RESULT', 'citation': 'Wang J, Yu W, Zhao D, Liu N, Yu Y. In-Hospital and Long-Term Mortality in 35,173 Chinese Patients Undergoing Coronary Artery Bypass Grafting in Beijing: Impact of Sex, Age, Myocardial Infarction, and Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):26-31. doi: 10.1053/j.jvca.2016.08.004. Epub 2016 Aug 4.'}, {'pmid': '25520374', 'type': 'RESULT', 'citation': 'Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.'}, {'pmid': '27760527', 'type': 'RESULT', 'citation': 'Pieri M, Belletti A, Monaco F, Pisano A, Musu M, Dalessandro V, Monti G, Finco G, Zangrillo A, Landoni G. Outcome of cardiac surgery in patients with low preoperative ejection fraction. BMC Anesthesiol. 2016 Oct 18;16(1):97. doi: 10.1186/s12871-016-0271-5.'}, {'pmid': '12730697', 'type': 'RESULT', 'citation': 'Abifadel M, Varret M, Rabes JP, Allard D, Ouguerram K, Devillers M, Cruaud C, Benjannet S, Wickham L, Erlich D, Derre A, Villeger L, Farnier M, Beucler I, Bruckert E, Chambaz J, Chanu B, Lecerf JM, Luc G, Moulin P, Weissenbach J, Prat A, Krempf M, Junien C, Seidah NG, Boileau C. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003 Jun;34(2):154-6. doi: 10.1038/ng1161.'}, {'pmid': '18033751', 'type': 'RESULT', 'citation': 'Careskey HE, Davis RA, Alborn WE, Troutt JS, Cao G, Konrad RJ. Atorvastatin increases human serum levels of proprotein convertase subtilisin/kexin type 9. J Lipid Res. 2008 Feb;49(2):394-8. doi: 10.1194/jlr.M700437-JLR200. Epub 2007 Nov 21.'}, {'pmid': '27919352', 'type': 'RESULT', 'citation': 'Boyer M, Levesque V, Poirier P, Marette A, Mathieu P, Despres JP, Larose E, Arsenault BJ. Impact of a 1-year lifestyle modification program on plasma lipoprotein and PCSK9 concentrations in patients with coronary artery disease. J Clin Lipidol. 2016 Nov-Dec;10(6):1353-1361. doi: 10.1016/j.jacl.2016.08.014. Epub 2016 Sep 2.'}, {'pmid': '19628659', 'type': 'RESULT', 'citation': "Baass A, Dubuc G, Tremblay M, Delvin EE, O'Loughlin J, Levy E, Davignon J, Lambert M. Plasma PCSK9 is associated with age, sex, and multiple metabolic markers in a population-based sample of children and adolescents. Clin Chem. 2009 Sep;55(9):1637-45. doi: 10.1373/clinchem.2009.126987. Epub 2009 Jul 23."}, {'pmid': '12937035', 'type': 'RESULT', 'citation': 'Chen YW, Hubal MJ, Hoffman EP, Thompson PD, Clarkson PM. Molecular responses of human muscle to eccentric exercise. J Appl Physiol (1985). 2003 Dec;95(6):2485-94. doi: 10.1152/japplphysiol.01161.2002. Epub 2003 Aug 22.'}, {'pmid': '17211497', 'type': 'RESULT', 'citation': 'Brooks N, Layne JE, Gordon PL, Roubenoff R, Nelson ME, Castaneda-Sceppa C. Strength training improves muscle quality and insulin sensitivity in Hispanic older adults with type 2 diabetes. Int J Med Sci. 2006 Dec 18;4(1):19-27. doi: 10.7150/ijms.4.19.'}, {'pmid': '25128757', 'type': 'RESULT', 'citation': 'Arsenault BJ, Pelletier-Beaumont E, Almeras N, Tremblay A, Poirier P, Bergeron J, Despres JP. PCSK9 levels in abdominally obese men: association with cardiometabolic risk profile and effects of a one-year lifestyle modification program. Atherosclerosis. 2014 Oct;236(2):321-6. doi: 10.1016/j.atherosclerosis.2014.07.010. Epub 2014 Jul 26.'}, {'pmid': '16826016', 'type': 'RESULT', 'citation': 'Shaibi GQ, Cruz ML, Ball GD, Weigensberg MJ, Salem GJ, Crespo NC, Goran MI. Effects of resistance training on insulin sensitivity in overweight Latino adolescent males. Med Sci Sports Exerc. 2006 Jul;38(7):1208-15. doi: 10.1249/01.mss.0000227304.88406.0f.'}, {'pmid': '10720604', 'type': 'RESULT', 'citation': 'Kelley GA, Kelley KS. Progressive resistance exercise and resting blood pressure : A meta-analysis of randomized controlled trials. Hypertension. 2000 Mar;35(3):838-43. doi: 10.1161/01.hyp.35.3.838.'}, {'pmid': '37946122', 'type': 'DERIVED', 'citation': 'Dwiputra B, Santoso A, Purwowiyoto BS, Radi B, Ambari AM. The effect of resistance training on PCSK9 levels in patients undergoing cardiac rehabilitation after coronary artery bypass grafting: a randomized study. BMC Cardiovasc Disord. 2023 Nov 9;23(1):549. doi: 10.1186/s12872-023-03571-7.'}], 'seeAlsoLinks': [{'url': 'http://www.pjnhk.go.id/', 'label': 'website of hospital where the study protocol will be held'}, {'url': 'http://www.ui.ac.id', 'label': 'website of educational institution inside the hospital'}]}, 'descriptionModule': {'briefSummary': 'This research add resistance training to patients who undergo cardiac rehabilitation program after coronary bypass surgery, comparing the level of PCSK9 level on that group to another group who receives conventional rehabilitation program (only aerobic exercise)', 'detailedDescription': 'The PCSK9 level measured before and after cardiac rehabilitation program (around 3-4 weeks), and compared between two groups. ELISA method will be used to measure plasma PCSK9 level.\n\nResistance training will be given by professional trainer in gymnasium of National Cardiovascular Center Harapan Kita supervised by cardiologists, following rules from American College of Sports Medicine guideline regarding to exercise after cardiac event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* post elective coronary artery bypass surgery\n* \\> 18 years old\n* sign informed consent\n\nExclusion Criteria:\n\n* contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic \\> 160 mmHg diastolic \\> 100 mmHg), acute heart failure, pulmonary diseases, arrhythmia malignant)\n* musculoskeletal pain, visual analog scale \\>3\n* post congenital heart disease surgery\n* post elective coronary artery bypass surgery with malfunction valves (operated or not)'}, 'identificationModule': {'nctId': 'NCT02674659', 'briefTitle': 'The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}, 'officialTitle': 'The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 (PCSK-9) Level in Patients After Coronary Bypass Surgery', 'orgStudyIdInfo': {'id': 'RUHK-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)', 'interventionNames': ['Behavioral: aerobic training']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)', 'interventionNames': ['Behavioral: resistance training', 'Behavioral: aerobic training']}], 'interventions': [{'name': 'resistance training', 'type': 'BEHAVIORAL', 'description': 'resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session was held for around 30 minutes.', 'armGroupLabels': ['Intervention group']}, {'name': 'aerobic training', 'type': 'BEHAVIORAL', 'description': 'aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bambang Dwiputra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cardiovascular Center Harapan Kita'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cardiovascular Center Harapan Kita Hospital Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bambang Dwiputra', 'investigatorAffiliation': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}}}}