Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT00929994
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2009-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dina.brooks@utoronto.ca', 'phone': '4169781739', 'title': 'Dr.', 'organization': 'Toronto Rehab'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was conducted in a single centre located in a large city centre and may lack generalizability to other programs, including those where CR services are not publicly funded.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exercise', 'description': 'Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding cardiac rehabilitation.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '498.4', 'spread': '95.2', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '503.2', 'spread': '111.1', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '564.2', 'spread': '139.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.06', 'groupIds': ['OG000'], 'pValueComment': 'A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all \\>.05).', 'groupDescription': 'With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.06', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, 6 months (Six Minute Walk Distance)', 'description': '6 minute walk test: the longest distance a person can walk for a duration of 6 minutes', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Transient Ischemic Attack participants who completed the 6 month intervention.'}, {'type': 'PRIMARY', 'title': 'Cardiovascular Fitness (VO2peak)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.7', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '19.1', 'spread': '4.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after the 3 month non-intervention period) and after 6 months of participation.', 'description': 'To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiologic Studies Depression Scale (CES-D).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program after a 12 week period of non intervention which will last 6 months and combine both resistance and aerobic training.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.5', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '7.6', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '4.3', 'spread': '5.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'pValueComment': 'A Bonferroni correction for multiple testing was used for post-hoc contrasts.', 'groupDescription': 'With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation', 'description': 'Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Transient Ischemic Attack. Two patients did not complete questionnaires.'}, {'type': 'SECONDARY', 'title': 'Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Following a 3 month non intervention period, participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '26.8', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '27.1', 'spread': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000'], 'pValueComment': 'A Bonferroni correction for multiple testing was used for post-hoc contrasts', 'groupDescription': 'With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation', 'description': 'Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TIA. Three subjects did not complete the assessment at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise', 'description': 'Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding the exercise program.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'medical issue unrelated to intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'employment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise', 'description': 'Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.\n\nCardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-20', 'studyFirstSubmitDate': '2009-06-29', 'resultsFirstSubmitDate': '2017-04-15', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-20', 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Walk Test', 'timeFrame': 'Baseline, 3 months, 6 months (Six Minute Walk Distance)', 'description': '6 minute walk test: the longest distance a person can walk for a duration of 6 minutes'}, {'measure': 'Cardiovascular Fitness (VO2peak)', 'timeFrame': 'Baseline (after the 3 month non-intervention period) and after 6 months of participation.', 'description': 'To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D).', 'timeFrame': 'Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation', 'description': 'Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).'}, {'measure': 'Cognition', 'timeFrame': 'Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation', 'description': 'Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac rehab'], 'conditions': ['Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': 'It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke.\n\nFurthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition.', 'detailedDescription': 'A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study with a 3 month non-intervention period. Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'TIA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with TIA\n* Three months post-TIA\n* Ability to understand the process and instructions for exercise training and provide informed consent\n\nExclusion Criteria:\n\n* Resting Blood Pressure greater than 160/100 despite medication\n* Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression \\> 2 mm, symptomatic aortic stenosis, complex arrhythmias)\n* Current and extensive exercise participation\n* Hypertrophic Cardiomyopathy\n* Unstable Angina\n* Orthostatic BP decrease of \\> 20 mm Hg with symptoms\n* Other musculoskeletal impairments which would limit the participants ability to walk sufficient durations\n* Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation\n* Cognitive or behavioural issues that would limit participation in exercise testing and training'}, 'identificationModule': {'nctId': 'NCT00929994', 'briefTitle': 'Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Rehabilitation Institute'}, 'officialTitle': 'Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack', 'orgStudyIdInfo': {'id': 'Brooks - 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exercise', 'description': 'Following a 3 month non intervention period, participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.', 'interventionNames': ['Behavioral: Cardiac Rehabilitation']}], 'interventions': [{'name': 'Cardiac Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 1R7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehabilitation Institute - Rumsey Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Dina Brooks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Rehabilitation Institute'}, {'name': 'William E McIllroy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}, {'name': 'Paul Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Rehabilitation Institute'}, {'name': 'Sandra Black, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sunnybrook and Women's College Health Centre"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Rehabilitation Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dina Brooks', 'investigatorAffiliation': 'Toronto Rehabilitation Institute'}}}}