Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-05 @ 2:49 AM
Study NCT ID:
NCT02107768
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2014-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Exercise in Early Subacute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EQ5-D', 'timeFrame': 'Baseline,3month,6month', 'description': 'Quality of life'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'Baseline,3month,6month', 'description': 'Recovery after stroke, participation'}], 'primaryOutcomes': [{'measure': 'Aerobic capacity', 'timeFrame': 'Baseline,3month', 'description': 'cardiorespiratory stress test (Watt)'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': 'Baseline,3month', 'description': 'Time Up and Go(TUG) ,Single Leg Stance(SLS)'}, {'measure': 'Walking capacity', 'timeFrame': 'Baseline,3month', 'description': 'Six minute walk test (6MWT ), 10 meters Walking test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Exercise', 'Randomized trial', 'Quality of Life'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '29338111', 'type': 'DERIVED', 'citation': 'Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.'}, {'pmid': '26903147', 'type': 'DERIVED', 'citation': 'Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand Swedish language.\n* Ability to walk 5 meters with or without the support of any means or person.\n* Be able to get up on a cycle ergometer and cycle in their own chosen pace.\n* Approval of medically responsible physician to conduct physical training in groups.\n\nExclusion Criteria:\n\n* Medical or neurological diseases that may affect the exercise execution.\n* Patients for whom transportation to and from hospital can not be arranged during intervention period'}, 'identificationModule': {'nctId': 'NCT02107768', 'briefTitle': 'Aerobic Exercise in Early Subacute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Ostergotland County Council, Sweden'}, 'officialTitle': 'Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2010/396-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise recommendation', 'description': 'Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts', 'interventionNames': ['Other: Aerobic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise', 'description': "The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added. The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20, Rate of Perceived Exertion (Borg 's RPE scale)\n\nTwo fitness goals was to be achieved during the training session:\n\n1\\. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate.\n\n2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) .Which corresponds to 85% of maximum heart rate.", 'interventionNames': ['Other: Aerobic exercise']}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'OTHER', 'description': "Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) .\n\nTwo fitness goals was to be achieved during the training session\n\n1\\. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate.\n\n2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate.", 'armGroupLabels': ['Aerobic exercise', 'Exercise recommendation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Klas Sandberg, Msc,RPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehab East, Local Health Care Östergötland County Council'}, {'name': 'Marie Kleist, Bsc,RPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehab East, Local Health Care Östergötland County Council'}, {'name': 'Lars Falk, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,'}, {'name': 'Paul Enthoven, PhD,RPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klas Sandberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc,RPT', 'investigatorFullName': 'Klas Sandberg', 'investigatorAffiliation': 'Ostergotland County Council, Sweden'}}}}