Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04821518
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart rate at rest', 'timeFrame': 'baseline', 'description': 'heart rate per minute'}, {'measure': 'heart rate at rest', 'timeFrame': '3 weeks', 'description': 'heart rate per minute'}, {'measure': 'heart rate after SMWT', 'timeFrame': 'baseline', 'description': 'heart rate per minute'}, {'measure': 'heart rate after SMWT', 'timeFrame': '3 weeks', 'description': 'heart rate per minute'}, {'measure': 'heart rate after SCT', 'timeFrame': 'baseline', 'description': 'heart rate per minute'}, {'measure': 'heart rate after SCT', 'timeFrame': '3 weeks', 'description': 'heart rate per minute'}, {'measure': 'heart rhythm at rest', 'timeFrame': 'baseline', 'description': 'heart rhythm interpreting ECG (regular or irregular)'}, {'measure': 'heart rhythm at rest', 'timeFrame': '3 weeks', 'description': 'heart rhythm interpreting ECG (regular or irregular)'}, {'measure': 'heart rhythm after SMWT', 'timeFrame': 'baseline', 'description': 'heart rhythm interpreting ECG (regular or irregular)'}, {'measure': 'heart rhythm after SMWT', 'timeFrame': '3 weeks', 'description': 'heart rhythm interpreting ECG (regular or irregular)'}, {'measure': 'heart rhythm after SCT', 'timeFrame': 'baseline', 'description': 'heart rhythm interpreting ECG (regular or irregular)'}, {'measure': 'heart rhythm after SCT', 'timeFrame': '3 weeks', 'description': 'heart rhythm interpreting ECG (regular or irregular)'}, {'measure': 'increased blood pressure at rest', 'timeFrame': 'baseline', 'description': 'blood pressure value \\[mm/Hg\\]'}, {'measure': 'increased blood pressure at rest', 'timeFrame': '3 weeks', 'description': 'blood pressure value \\[mm/Hg\\]'}, {'measure': 'increased blood pressure after SMWT', 'timeFrame': 'baseline', 'description': 'blood pressure value \\[mm/Hg\\]'}, {'measure': 'increased blood pressure after SMWT', 'timeFrame': '3 weeks', 'description': 'blood pressure value \\[mm/Hg\\]'}, {'measure': 'increased blood pressure after SCT', 'timeFrame': 'baseline', 'description': 'blood pressure value \\[mm/Hg\\]'}, {'measure': 'increased blood pressure after SCT', 'timeFrame': '3 weeks', 'description': 'blood pressure value \\[mm/Hg\\]'}, {'measure': 'Distance of walk after SMWT', 'timeFrame': 'baseline', 'description': 'Distance (metres)'}, {'measure': 'Distance of walk after SMWT', 'timeFrame': '3 weeks', 'description': 'Distance (metres)'}, {'measure': 'Distance of walk after SCT', 'timeFrame': 'baseline', 'description': 'Distance (metres)'}, {'measure': 'Distance of walk after SCT', 'timeFrame': '3 weeks', 'description': 'Distance (metres)'}, {'measure': 'Steps after SMWT', 'timeFrame': 'baseline', 'description': 'Number of steps (number)'}, {'measure': 'Steps after SMWT', 'timeFrame': '3 weeks', 'description': 'Number of steps (number)'}, {'measure': 'Steps after SCT', 'timeFrame': 'baseline', 'description': 'Number of steps (number)'}, {'measure': 'Steps after SCT', 'timeFrame': '3 weeks', 'description': 'Number of steps (number)'}, {'measure': 'Velocity of walk after SMWT', 'timeFrame': 'baseline', 'description': 'Mean velocity (km/h)'}, {'measure': 'Velocity of walk after SMWT', 'timeFrame': '3 weeks', 'description': 'Mean velocity (km/h)'}, {'measure': 'Velocity of walk after SCT', 'timeFrame': 'baseline', 'description': 'Mean velocity (km/h)'}, {'measure': 'Velocity of walk after SCT', 'timeFrame': '3 weeks', 'description': 'Mean velocity (km/h)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mobile Applications', 'Secondary Prevention', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '34071967', 'type': 'DERIVED', 'citation': 'Lucki M, Chlebus E, Warenczak A, Lisinski P. The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance in the Secondary Prevention in Patients after Ischemic Stroke. Int J Environ Res Public Health. 2021 May 27;18(11):5753. doi: 10.3390/ijerph18115753.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of cardiological parameters.', 'detailedDescription': 'In the post-stroke group and in the control group, SMWT (Six Minute Walk Test) and SCT( Stair Climb Test) were preceded by a 10-minute rest in sitting position. The time of test performance, the walked distance and steps made as well as the mean and maximum gait velocity and the calories burned were assessed using the above-mentioned Samsung Health application . ECG results were assessed with the use of ECG M-Trace Base II application described above. In addition, cardiological parameters such as: systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR) and arterial blood saturation were assessed. The measurements were performed at rest and directly after SCMT and SCT. Additionally, after the tests, the level of dyspnoea and fatigue was assessed according to the modified Borg scale (score 0-10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '42 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department.\n\nThe control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria to the post-stroke group were as follows :\n\n1. occurrence of hemiparesis after the first episode of ischaemic stroke\n2. stroke confirmed in the diagnostic imaging records\n3. score \\>3 on Lovett's scale of muscle strength in the paretic limbs\n4. score above 15 in Barthel's scale of performance in activities of daily living\n5. score below 12 in the National Institutes of Health Stroke Scale (NIHSS)\n6. available complete medical records concerning the assessed risk factors of recurrent CVD event\n7. lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma\n\nExclusion criteria from the post-stroke group were as follows:\n\n1. hemiparesis or tetraparesis following many episodes of stroke,\n2. lack of diagnostic imaging scans confirming the occurrence of stroke\n3. hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke\n4. incomplete medical records concerning the assessed risk factors of recurrent CVD event\n5. score \\>3 on Lovett's scale of muscle strength in the paretic limbs\n6. score below 14 in Barthel's scale of performance in activities of daily living\n7. score above 13 in the NIHSS scale\n8. occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases."}, 'identificationModule': {'nctId': 'NCT04821518', 'briefTitle': 'The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke', 'orgStudyIdInfo': {'id': '1/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study group (post-stroke)', 'description': 'The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań'}, {'label': 'The control group', 'description': 'The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-545', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Department of Rehabilitation and Physiotherapy Rehabilitation,', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Ewa Chlebuś', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic Rehabilitation, University of Medical Sciences in Poznań'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}