Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT03507894
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '8 weeks', 'description': 'Adherence will be monitored with an app that will record activity time (walking time and distance)'}], 'secondaryOutcomes': [{'measure': 'Gait speed', 'timeFrame': '8 weeks', 'description': 'Gait speed will be measured with the Ten Meter Walking Test (10MWT). Participants will be given a 2-meter warm-up distance for walking, preceding the 10-meter distance, and 2 meters beyond the 10 meters. The time that takes to walk 10 meters at a comfortable pace and at their maximum speed will be registered in meters/second'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'exercise', 'stroke', 'adherence'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '34184251', 'type': 'DERIVED', 'citation': 'Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.', 'detailedDescription': 'This is a 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. The aim of the MERP is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. The mobile app technology complements the MERP in order to achieve long term adherence to healthy physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be stroke survivors who have completed a conventional rehabilitation program. They will be recruited from Hospital-Consorci Sanitari de Terrassa (Barcelona, Spain) over a period of six months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ischemic or hemorrhagic stroke\n* age ≥18;\n* Functional Ambulation Classification (FAC) ≥3\n* Barthel Index ≥45\n\nExclusion Criteria:\n\n* Cognitive impairment (Mini Mental State Examination ≤24)\n* Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)\n* Alcohol or other toxic substances abuse\n* Decompensated psychiatric disorders that prevented from following a group session'}, 'identificationModule': {'nctId': 'NCT03507894', 'briefTitle': 'Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study', 'orgStudyIdInfo': {'id': 'ConsorciST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'm-health stroke rehabilitation', 'description': '8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology', 'interventionNames': ['Behavioral: Multimodal Exercise Rehabilitation Program']}], 'interventions': [{'name': 'Multimodal Exercise Rehabilitation Program', 'type': 'BEHAVIORAL', 'description': 'Rehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology', 'armGroupLabels': ['m-health stroke rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08232', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Montserrat Grau-Pellicer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Sanitari de Terrassa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Montserrat Grau-Pellicer', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}