Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01186367
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2010-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scottj1@mskcc.org', 'phone': '646-888-8093', 'title': 'Dr. Jessica Scott, PhD', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.\n\nLinear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 58, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.\n\nNonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Progressive Stretching Group (Attention Control)', 'description': "The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).\n\nProgressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count", 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 8, 'seriousNumAtRisk': 57, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnormal heart response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower extremity fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal blood pressure response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low oxygen saturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.\n\nLinear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'OG001', 'title': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.\n\nNonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'OG002', 'title': 'Progressive Stretching Group (Attention Control)', 'description': "The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).\n\nProgressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count"}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '21.8', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'VO2 or peak oxygen consumption will be measured at Baseline', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.\n\nLinear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'OG001', 'title': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.\n\nNonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'OG002', 'title': 'Progressive Stretching Group (Attention Control)', 'description': "The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).\n\nProgressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count"}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only nonlinear aerobic training measured at 8 weeks'}, {'type': 'PRIMARY', 'title': 'To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.\n\nLinear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'OG001', 'title': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.\n\nNonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'OG002', 'title': 'Progressive Stretching Group (Attention Control)', 'description': "The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).\n\nProgressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count"}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '21.8', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Nonlinear aerobic training measured at 16 weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.\n\nLinear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'FG001', 'title': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.\n\nNonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'FG002', 'title': 'Progressive Stretching Group (Attention Control)', 'description': "The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).\n\nProgressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Did not receive study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.\n\nLinear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'BG001', 'title': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.\n\nNonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count'}, {'id': 'BG002', 'title': 'Progressive Stretching Group (Attention Control)', 'description': "The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).\n\nProgressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.\n\nCardiopulmonary exercise test (CPET)\n\nBlood draws: Complete blood count"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '76'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '78'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '73'}, {'value': '58', 'groupId': 'BG003', 'lowerLimit': '33', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-07', 'size': 923742, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-09T09:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2010-08-19', 'resultsFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-07', 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.', 'timeFrame': 'Baseline', 'description': 'VO2 or peak oxygen consumption will be measured at Baseline'}, {'measure': 'To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.', 'timeFrame': '8 weeks', 'description': 'VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)'}, {'measure': 'To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.', 'timeFrame': '16 weeks', 'description': 'VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'Linear Versus Nonlinear Aerobic Training', '15-147'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '32065769', 'type': 'RESULT', 'citation': 'Scott JM, Thomas SM, Peppercorn JM, Herndon JE 2nd, Douglas PS, Khouri MG, Dang CT, Yu AF, Catalina D, Ciolino C, Capaci C, Michalski MG, Eves ND, Jones LW. Effects of Exercise Therapy Dosing Schedule on Impaired Cardiorespiratory Fitness in Patients With Primary Breast Cancer: A Randomized Controlled Trial. Circulation. 2020 Feb 18;141(7):560-570. doi: 10.1161/CIRCULATIONAHA.119.043483. Epub 2020 Feb 17.'}, {'pmid': '35818548', 'type': 'DERIVED', 'citation': 'Michalski M, Rowed K, Lavery JA, Moskowitz CS, Capaci C, Stene G, Edvardsen E, Eves ND, Jones LW, Scott JM. Validity of Estimated Cardiorespiratory Fitness in Patients With Primary Breast Cancer. JACC CardioOncol. 2022 Jun 21;4(2):210-219. doi: 10.1016/j.jaccao.2022.05.003. eCollection 2022 Jun.'}, {'pmid': '20925920', 'type': 'DERIVED', 'citation': 'Jones LW, Douglas PS, Eves ND, Marcom PK, Kraus WE, Herndon JE 2nd, Inman BA, Allen JD, Peppercorn J. Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer. BMC Cancer. 2010 Oct 6;10:531. doi: 10.1186/1471-2407-10-531.'}], 'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 45-80 years\n* Female\n* Has been diagnosed with early-stage breast cancer\n* Post-menopausal, defined as :\n* Age ≥ 45 with no menses for at least 2 years\n* Chemically induced menopause through ovarian suppression, as determined by the primary oncologist\n* An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease. Primary therapy is defined as:\n\n * Surgery plus radiation\n * Surgery plus chemotherapy\n * Surgery plus trastuzumab\n * Surgery plus hormone therapy Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date. Patients who are currently receiving hormone therapy are eligible for enrollment.\n* Weight of \\< 205 kgs\n* ECOG status of 0 or 1\n* Life expectancy ≥ 6 months\n* Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week.\n* Exercise intolerance defined by a VO2peak below that predicted for sedentary age and sex-matched individuals as defined in Appendix H.\n* Willing to be randomized to one of the study arms\n* Able to complete an acceptable baseline CPET, in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.\n* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\n\n * Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\n * A respiratory exchange ratio ≥ 1.10;\n * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \\[HRmax = 220-Age\\[years\\]);\n * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.\n\nExclusion Criteria:\n\n* Any of the following absolute contraindications to cardiopulmonary exercise testing:\n\n * Acute myocardial infarction within 3-5 days of any planned study procedures;\n * Unstable angina;\n * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;\n * Recurrent syncope;\n * Active endocarditis;\n * Acute myocarditis or pericarditis;\n * Symptomatic severe aortic stenosis;\n * Uncontrolled heart failure;\n * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures\n * Thrombosis of lower extremities;\n * Suspected dissecting aneurysm;\n * Uncontrolled asthma;\n * Pulmonary edema;\n * Respiratory failure;\n * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis);\n* Presence of any other concurrent, actively treated malignancy\n* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)\n* Presence of metastatic disease\n* Room air desaturation at rest ≤ 85%\n* Mental impairment leading to inability to cooperate\n* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial'}, 'identificationModule': {'nctId': 'NCT01186367', 'acronym': 'Excite', 'briefTitle': 'Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer', 'orgStudyIdInfo': {'id': '15-147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.', 'interventionNames': ['Behavioral: Linear Aerobic Training', 'Other: Cardiopulmonary exercise test (CPET)', 'Other: Blood draws']}, {'type': 'EXPERIMENTAL', 'label': 'Nonlinear Aerobic Training', 'description': 'The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.', 'interventionNames': ['Behavioral: Nonlinear Aerobic Training', 'Other: Cardiopulmonary exercise test (CPET)', 'Other: Blood draws']}, {'type': 'EXPERIMENTAL', 'label': 'Progressive Stretching Group (Attention control)', 'description': 'The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).', 'interventionNames': ['Behavioral: Progressive Stretching', 'Other: Cardiopulmonary exercise test (CPET)', 'Other: Blood draws']}], 'interventions': [{'name': 'Linear Aerobic Training', 'type': 'BEHAVIORAL', 'description': 'The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).', 'armGroupLabels': ['Linear Aerobic Training']}, {'name': 'Nonlinear Aerobic Training', 'type': 'BEHAVIORAL', 'description': 'The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).', 'armGroupLabels': ['Nonlinear Aerobic Training']}, {'name': 'Progressive Stretching', 'type': 'BEHAVIORAL', 'description': "All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.", 'armGroupLabels': ['Progressive Stretching Group (Attention control)']}, {'name': 'Cardiopulmonary exercise test (CPET)', 'type': 'OTHER', 'armGroupLabels': ['Linear Aerobic Training', 'Nonlinear Aerobic Training', 'Progressive Stretching Group (Attention control)']}, {'name': 'Blood draws', 'type': 'OTHER', 'description': 'Complete blood count', 'armGroupLabels': ['Linear Aerobic Training', 'Nonlinear Aerobic Training', 'Progressive Stretching Group (Attention control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jessica Scott, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}