Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-20 @ 11:10 PM
Study NCT ID:
NCT02902367
Status:
UNKNOWN
Last Update Posted:
2017-09-19
First Post:
2016-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-13', 'releaseDate': '2022-11-01'}, {'resetDate': '2024-04-11', 'releaseDate': '2023-10-03'}], 'estimatedResultsFirstSubmitDate': '2022-11-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'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': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-17', 'studyFirstSubmitDate': '2016-09-11', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walk test (6MWT)', 'timeFrame': 'from baseline walking capacity to three months', 'description': 'walking capacity'}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'from baseline SPPB to three months', 'description': 'mobility'}, {'measure': '10 meter walk test (10mWT)', 'timeFrame': 'from baseline 10mWT to three months', 'description': 'gait speed'}, {'measure': 'Hand-dynamometer (Jamar)', 'timeFrame': 'from baseline Jamar to three months', 'description': 'hand-grip strength'}, {'measure': 'Body composition (bioelectric impedance analysis)', 'timeFrame': 'from baseline body composition to three months', 'description': 'muscles and fat mass and BMI'}, {'measure': 'Cardiometabolic risk markers', 'timeFrame': 'from baseline cardiometabolic risk markers to three months', 'description': 'blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)'}, {'measure': 'Heart and lung foundation stress test', 'timeFrame': 'at baseline', 'description': 'self-perceived stress'}, {'measure': 'Food frequency questionnaire', 'timeFrame': 'at baseline', 'description': 'self-reported food intake and quality'}, {'measure': 'Montreal outcome assessment (MoCA)', 'timeFrame': 'at baseline', 'description': 'cognition'}, {'measure': 'Modified rankin scale (MRS)', 'timeFrame': 'at baseline', 'description': 'motor function'}, {'measure': 'Mortality', 'timeFrame': 'from baseline to 1 year', 'description': 'register-based mortality'}, {'measure': 'Health-related quality of life', 'timeFrame': 'from baseline to 1 year', 'description': 'register-based quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mobility', 'exercise', 'walking capacity', 'fat mass', 'muscles'], 'conditions': ['Acute Stroke', 'TIA (Transient Ischemic Attack)']}, 'referencesModule': {'references': [{'pmid': '38443081', 'type': 'DERIVED', 'citation': 'Vahlberg BM, Eriksson S, Holmback U, Lundstrom E. Factors associated with changes in walking performance in individuals 3 months after stroke or TIA: secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden. BMJ Open. 2024 Mar 4;14(3):e078180. doi: 10.1136/bmjopen-2023-078180.'}, {'pmid': '34663672', 'type': 'DERIVED', 'citation': 'Vahlberg BM, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Potential effects on cardiometabolic risk factors and body composition by short message service (SMS)-guided training after recent minor stroke or transient ischaemic attack: post hoc analyses of the STROKEWALK randomised controlled trial. BMJ Open. 2021 Oct 18;11(10):e054851. doi: 10.1136/bmjopen-2021-054851.'}, {'pmid': '32942914', 'type': 'DERIVED', 'citation': 'Vahlberg B, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Effects on walking performance and lower body strength by short message service guided training after stroke or transient ischemic attack (The STROKEWALK Study): a randomized controlled trial. Clin Rehabil. 2021 Feb;35(2):276-287. doi: 10.1177/0269215520954346. Epub 2020 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity, mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be documented.', 'detailedDescription': 'Eighty community-living individuals in Uppsala municipality will be included in a randomized controlled trial with two arms.\n\nIntervention: Participants will perform an outdoor walking exercise program together with one strength exercise for 12 weeks. The intensity and frequency of the training will progressively increase. Participants are supposed to walk and perform strength training 5-7 days/week.\n\nMethods: Clinical assessments, questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.\n\nAssessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity (primary outcome measure), mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be evaluated.\n\nPower analysis is performed. The investigators will analyze the data using an intention-to -treat analysis. Participants should have participated in at least 50% of the training sessions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Verified ischemic cerebral infarction or intracerebral hemorrhage.\n2. Sufficient walking capacity and motor function\n3. Able to communicate in Swedish\n4. Signed consent\n\nExclusion Criteria:\n\nOne or more of the following:\n\n1. Subarachnoid bleeding\n2. Insufficient cognition and impaired ability to understand instructions\n3. Medical problems that make it unsuitable to participate\n4. Pacemaker (body composition measurements)'}, 'identificationModule': {'nctId': 'NCT02902367', 'acronym': 'SMS/TIA', 'briefTitle': 'Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Uppsala County Council, Sweden'}, 'officialTitle': 'Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UppsalaCC2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention:', 'description': 'Outdoor walking and strength exercise, Three months, daily SMS.', 'interventionNames': ['Other: Outdoor walking and strength exercise']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Usual care; no restriction for exercise, Three months', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'Outdoor walking and strength exercise', 'type': 'OTHER', 'otherNames': ['exercise'], 'description': 'Exercise group: Participants are supposed to perform an outdoor walking exercise program and one strength exercise for 12 weeks. The first 2 weeks start with daily walks. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, i.e. chair-rising which also should be performed daily.', 'armGroupLabels': ['Intervention:']}, {'name': 'control group', 'type': 'OTHER', 'otherNames': ['control'], 'description': 'Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Birgit Vahlberg, Med Dr, RPT', 'role': 'CONTACT', 'email': 'birgit.vahlberg@pubcare.uu.se', 'phone': '+18709583473'}, {'name': 'Tommy Cederholm, Professor', 'role': 'CONTACT', 'email': 'tommy.cederholm@pubcare.uu.se', 'phone': '+18702733192'}], 'facility': 'Birgit Vahlberg', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Birgit Vahlberg, Med Dr, RPT', 'role': 'CONTACT', 'email': 'birgit.vahlberg@pubcare.uu.se', 'phone': '+46709583473'}, {'name': 'Tommy Cederholm, Professor,MD', 'role': 'CONTACT', 'email': 'tommy.cederholm@pubcare.uu.se', 'phone': '+46702733192'}], 'overallOfficials': [{'name': 'Birgit Vahlberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sweden,Uppsala Uppsala University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala County Council, Sweden', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md Dr, RPT', 'investigatorFullName': 'Birgit Vahlberg', 'investigatorAffiliation': 'Uppsala County Council, Sweden'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-01', 'type': 'RELEASE'}, {'date': '2023-09-13', 'type': 'RESET'}, {'date': '2023-10-03', 'type': 'RELEASE'}, {'date': '2024-04-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Birgit Vahlberg, PhD, RPT, Uppsala County Council, Sweden'}}}}