Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 9:53 AM
Study NCT ID:
NCT03892460
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2019-03-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transitional Rehabilitation in CABG Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.toth@med.uvm.edu', 'phone': '802-656-7989', 'title': 'Michael Toth', 'organization': 'University of Vermont College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'First, patients were not blinded to treatment status because NMES elicits skeletal muscle contraction and any sham treatment would not. Second, study personnel were not blinded, as resources were insufficient for unblinded and blinded personnel. Third, we did not analyze data using an intent-to-treat approach. Fourth, our study included few women. Finally, our study is limited to the strict inclusion/exclusion criteria and studies in larger cohorts are required to assess external validity.'}}, 'adverseEventsModule': {'timeFrame': '1-month post-surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'No treatment control', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pleuritic chest pain', 'notes': 'Pleuritic chest pain during functional stesting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Short Physical Performance Battery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '7.33', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '11.44', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '10.90', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6 Minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '216', 'spread': '22', 'groupId': 'OG000'}, {'value': '238', 'spread': '21', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '482', 'spread': '21', 'groupId': 'OG000'}, {'value': '431', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': '6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in cardiac surgery patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36 - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '40', 'spread': '7', 'groupId': 'OG000'}, {'value': '33', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '70', 'spread': '5', 'groupId': 'OG000'}, {'value': '58', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in physical function due to health problems. Lower scores represent more physical function disability, while higher scores represent less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcome Short Form 36 - Role Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '26', 'spread': '10', 'groupId': 'OG000'}, {'value': '21', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '19', 'spread': '8', 'groupId': 'OG000'}, {'value': '18', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in usual role activities because of physical health problems. Lower scores represent more disability, while higher scores represent less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36 - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '31', 'spread': '4', 'groupId': 'OG000'}, {'value': '28', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '28', 'spread': '3', 'groupId': 'OG000'}, {'value': '27', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-week post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on bodily pain. Lower scores represent more pain, while higher scores represent less pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36 - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '71', 'spread': '4', 'groupId': 'OG000'}, {'value': '63', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '81', 'spread': '3', 'groupId': 'OG000'}, {'value': '72', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-week post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '55', 'spread': '5', 'groupId': 'OG000'}, {'value': '53', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': '4-weeks post-discharge', 'categories': [{'measurements': [{'value': '55', 'spread': '4', 'groupId': 'OG000'}, {'value': '51', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on vitality (energy and fatigue). Lower scores represent less vitality, while higher scores represent more vitality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '74', 'spread': '7', 'groupId': 'OG000'}, {'value': '63', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': '4-week post-discharge', 'categories': [{'measurements': [{'value': '76', 'spread': '6', 'groupId': 'OG000'}, {'value': '72', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in social activities because of physical or emotional problems. Lower scores represent more more limitations, while higher scores represent less lmitations.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36 - Role Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '65', 'spread': '11', 'groupId': 'OG000'}, {'value': '54', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': '4-week post-discharge', 'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'OG000'}, {'value': '51', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-week discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in usual role activities because of emotional problems. Lower scores represent more limitations, while higher scores represent less limitations.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Short Form 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '77', 'spread': '4', 'groupId': 'OG000'}, {'value': '74', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': '4-week post-discharge', 'categories': [{'measurements': [{'value': '86', 'spread': '4', 'groupId': 'OG000'}, {'value': '78', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital discharge and 4-week post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment control'}], 'classes': [{'categories': [{'measurements': [{'value': '125.6', 'groupId': 'OG000'}, {'value': '109.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Daily from discharge to 4-week post-discharge evaluation', 'description': 'Physical activity was measured throughout the intervention in control and treatment groups and data. Data were analyzed by regression analysis to obtain the best fit line for the data and to compute a slope of the change in step count with day post-discharge to examine whether groups differed in their rate of recovery of weight-bearing activity (ie, walking).', 'unitOfMeasure': 'step counts per day', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'FG001', 'title': 'Control', 'description': 'No treatment control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Neuromuscular electrical stimulation\n\nneuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation'}, {'id': 'BG001', 'title': 'Control', 'description': 'No treatment control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '65.7', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-17', 'size': 512099, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-10T14:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-10', 'studyFirstSubmitDate': '2019-03-26', 'resultsFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-10', 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Physical Performance Battery', 'timeFrame': '4 weeks', 'description': 'Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk Distance', 'timeFrame': '4 weeks', 'description': '6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in cardiac surgery patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course.'}, {'measure': 'Medical Outcomes Short Form 36 - Physical Function', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in physical function due to health problems. Lower scores represent more physical function disability, while higher scores represent less disability.'}, {'measure': 'Medical Outcome Short Form 36 - Role Physical', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in usual role activities because of physical health problems. Lower scores represent more disability, while higher scores represent less disability.'}, {'measure': 'Medical Outcomes Short Form 36 - Bodily Pain', 'timeFrame': 'Hospital discharge and 4-week post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on bodily pain. Lower scores represent more pain, while higher scores represent less pain.'}, {'measure': 'Medical Outcomes Short Form 36 - General Health', 'timeFrame': 'Hospital discharge and 4-week post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.'}, {'measure': 'Medical Outcomes Short Form 36 - Vitality', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on vitality (energy and fatigue). Lower scores represent less vitality, while higher scores represent more vitality.'}, {'measure': 'Medical Outcomes Short Form 36 - Social Function', 'timeFrame': 'Hospital discharge and 4-weeks post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in social activities because of physical or emotional problems. Lower scores represent more more limitations, while higher scores represent less lmitations.'}, {'measure': 'Medical Outcomes Short Form 36 - Role Emotional', 'timeFrame': 'Hospital discharge and 4-week discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in usual role activities because of emotional problems. Lower scores represent more limitations, while higher scores represent less limitations.'}, {'measure': 'Medical Outcomes Short Form 36', 'timeFrame': 'Hospital discharge and 4-week post-discharge', 'description': 'The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health.'}, {'measure': 'Physical Activity', 'timeFrame': 'Daily from discharge to 4-week post-discharge evaluation', 'description': 'Physical activity was measured throughout the intervention in control and treatment groups and data. Data were analyzed by regression analysis to obtain the best fit line for the data and to compute a slope of the change in step count with day post-discharge to examine whether groups differed in their rate of recovery of weight-bearing activity (ie, walking).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Coronary Artery Bypass Graft Surgery']}, 'referencesModule': {'references': [{'pmid': '33512980', 'type': 'DERIVED', 'citation': 'Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Improvement in Physical Function After Coronary Artery Bypass Graft Surgery Using a Novel Rehabilitation Intervention: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):413-418. doi: 10.1097/HCR.0000000000000576.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.', 'detailedDescription': 'Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important treatment option for coronary artery disease. The post-surgery period of rest and recovery is associated with cardiorespiratory and skeletal muscle deconditioning. The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a bridge between surgery and the start of cardiac rehabilitation to preserve or improve physical function. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery. Assessments will include measurements of physical function by the Short Physical Performance Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36. Additionally, accelerometry will be used to monitor weight-bearing physical activity during the 4 week treatment phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50-80 yrs of age\n* ambulatory\n* scheduled for coronary artery bypass graft surgery\n* able to provide informed consent\n\nExclusion Criteria:\n\n* rheumatoid arthritis or other inflammatory/autoimmune disease\n* cancer, excluding non-melanoma skin cancer\n* exercise limiting peripheral vascular disease\n* neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event\n* body mass index \\>38 kg/m2\n* valvular heart disease not corrected surgically\n* lower extremity blood clot or implantable cardioverter-defibrillator'}, 'identificationModule': {'nctId': 'NCT03892460', 'briefTitle': 'Transitional Rehabilitation in CABG Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients', 'orgStudyIdInfo': {'id': '17-0413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Neuromuscular electrical stimulation', 'interventionNames': ['Device: neuromuscular electrical stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No treatment control'}], 'interventions': [{'name': 'neuromuscular electrical stimulation', 'type': 'DEVICE', 'description': 'bilateral quadriceps exercise with neuromuscular electrical stimulation', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont College of Medicine', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Michael J. Toth, Ph.D.', 'investigatorAffiliation': 'University of Vermont'}}}}