Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 10:35 PM
Study NCT ID:
NCT01915368
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Optimal Post-Stroke Exercise (DOSE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-16', 'releaseDate': '2020-08-27'}], 'estimatedResultsFirstSubmitDate': '2020-08-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'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': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory function measured by the Six Minute Walk Test', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission)'}], 'secondaryOutcomes': [{'measure': 'Ambulatory Function from the Six Minute Walk Test', 'timeFrame': '6 and 12 months post-stroke'}, {'measure': 'Ambulatory function from the 5 Meter Walk Test', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke'}, {'measure': 'Balance function from the Berg Balance Scale', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke'}, {'measure': 'Ambulatory function from the Functional Ambulation Classification', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke'}, {'measure': 'Quality of life measured with EuroQol', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke'}, {'measure': 'Cognition measured by the Montreal Cognitive Assessment', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke'}, {'measure': 'Cognition measured by the Digit Symbols Substitution Test', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke'}, {'measure': 'Cognition measured by the Trail Making Test', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke'}, {'measure': 'Depression measured by Patient Health Questionnaire-9', 'timeFrame': 'Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke'}, {'measure': 'Heart rate measured during the intervention sessions', 'timeFrame': 'From 10 intervention sessions within the 4-week intervention'}, {'measure': 'Step count measured during the intervention sessions', 'timeFrame': 'From 10 intervention sessions within the 4-week intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise', 'Rehabilitation', 'Dose', 'Randomized controlled trial', 'Stroke'], 'conditions': ['Cerebrovascular Accident', 'Stroke', 'Cerebral Infarction', 'Brain Infarction', 'Brain Ischemia', 'Cerebrovascular Disorders', 'Brain Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '37360352', 'type': 'DERIVED', 'citation': 'Peters S, Lohse KR, Klassen TD, Liu-Ambrose T, Dukelow SP, Bayley MT, Hill MD, Pooyania S, Yao J, Eng JJ. Higher intensity walking improves global cognition during inpatient rehabilitation: a secondary analysis of a randomized control trial. Front Neurol. 2023 Jun 9;14:1023488. doi: 10.3389/fneur.2023.1023488. eCollection 2023.'}, {'pmid': '34949129', 'type': 'DERIVED', 'citation': 'Peters S, Klassen T, Schneeberg A, Dukelow S, Bayley M, Hill M, Pooyania S, Yao J, Eng J. Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. Neurorehabil Neural Repair. 2022 Feb;36(2):97-102. doi: 10.1177/15459683211062894. Epub 2021 Dec 23.'}, {'pmid': '32811378', 'type': 'DERIVED', 'citation': 'Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Schneeberg A, Yao J, Eng JJ. Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation. Stroke. 2020 Sep;51(9):2639-2648. doi: 10.1161/STROKEAHA.120.029245. Epub 2020 Aug 19.'}, {'pmid': '31711211', 'type': 'DERIVED', 'citation': 'Janssen J, Klassen TD, Connell LA, Eng JJ. Factors Influencing the Delivery of Intensive Rehabilitation in Stroke: Patient Perceptions Versus Rehabilitation Therapist Perceptions. Phys Ther. 2020 Feb 7;100(2):307-316. doi: 10.1093/ptj/pzz159.'}, {'pmid': '30010509', 'type': 'DERIVED', 'citation': 'Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Yao J, Eng JJ. Determining optimal poststroke exercise: Study protocol for a randomized controlled trial investigating therapeutic intensity and dose on functional recovery during stroke inpatient rehabilitation. Int J Stroke. 2019 Jan;14(1):80-86. doi: 10.1177/1747493018785064. Epub 2018 Jul 16.'}, {'pmid': '28784922', 'type': 'DERIVED', 'citation': 'Klassen TD, Semrau JA, Dukelow SP, Bayley MT, Hill MD, Eng JJ. Consumer-Based Physical Activity Monitor as a Practical Way to Measure Walking Intensity During Inpatient Stroke Rehabilitation. Stroke. 2017 Sep;48(9):2614-2617. doi: 10.1161/STROKEAHA.117.018175. Epub 2017 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.', 'detailedDescription': 'Participants admitted for stroke rehabilitation will be randomly assigned to either the Stroke Management Group, Stroke Monitoring Group or Stroke Supplementary Group. All three groups will receive usual care, in addition to the intervention. The Stroke Management Group will be provided with periodic information about their progress in the area of mobility using specialized activity monitors. The Stroke Monitoring Group will be progressed according to customized protocols using feedback from specialized activity monitors. The Stroke Supplementary Group will receive the same as the Stroke Monitoring Group, but will also receive one additional hour of daily (5 times per week) physical exercise'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been admitted to a hospital unit for stroke rehabilitation\n* Within 10 weeks post-stroke\n* 19 years or older\n* Are experiencing difficulty walking\n\nExclusion Criteria:\n\n* Requires greater than one person assist for transfer or ambulation\n* Have uncontrolled medical condition or another serious medication condition in addition to stroke\n* Unable to understand or follow directions'}, 'identificationModule': {'nctId': 'NCT01915368', 'briefTitle': 'Determining Optimal Post-Stroke Exercise (DOSE)', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Determining Optimal Post-Stroke Exercise (DOSE)', 'orgStudyIdInfo': {'id': 'H13-01933'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stroke Management Program (SMP)', 'description': 'Participants will have usual care, and in addition, be provided with periodic information about their progress in the area of mobility using specialized activity monitors', 'interventionNames': ['Behavioral: Stroke Management Program (SMP)']}, {'type': 'EXPERIMENTAL', 'label': 'Stroke Monitoring Program (SMonP)', 'description': 'Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors', 'interventionNames': ['Behavioral: Stroke Monitoring Program (SMonP)']}, {'type': 'EXPERIMENTAL', 'label': 'Stroke Supplementary Program (SSP)', 'description': 'Participants will have usual care, and in addition, will receive the same as the Stroke Monitoring Group, and also receive one additional hour of daily (5 times per week) physical exercise', 'interventionNames': ['Behavioral: Stroke Supplementary Program (SSP)']}], 'interventions': [{'name': 'Stroke Management Program (SMP)', 'type': 'BEHAVIORAL', 'description': 'Participants will have usual care, and in addition, be provided with periodic information about their progress in the area of mobility using specialized activity monitors', 'armGroupLabels': ['Stroke Management Program (SMP)']}, {'name': 'Stroke Monitoring Program (SMonP)', 'type': 'BEHAVIORAL', 'description': 'Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors', 'armGroupLabels': ['Stroke Monitoring Program (SMonP)']}, {'name': 'Stroke Supplementary Program (SSP)', 'type': 'BEHAVIORAL', 'description': 'Participants will have usual care, and in addition, will receive the same as the Stroke Monitoring Group, and also receive one additional hour of daily (5 times per week) physical exercise', 'armGroupLabels': ['Stroke Supplementary Program (SSP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Fanning Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V3T 4H9', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Laurel Place', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Surrey Memorial Hospital', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 2G9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GF Strong Rehab Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Holy Family Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3L 2P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Riverview Health Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehabilitation Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Janice Eng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Janice Eng', 'investigatorAffiliation': 'University of British Columbia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-27', 'type': 'RELEASE'}, {'date': '2020-09-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Janice Eng, Principal Investigator, University of British Columbia'}}}}