Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-04-15 @ 12:06 AM
Study NCT ID:
NCT01560520
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2011-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Immediately After Acute Cerebral Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2011-11-02', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'activity counts per day', 'timeFrame': 'up to 7 days'}], 'secondaryOutcomes': [{'measure': 'Inflammation level', 'timeFrame': 'up to 7 days', 'description': 'biomarker concentration'}, {'measure': 'Disability', 'timeFrame': 'up to 7 days', 'description': 'Scandinavian Stroke Scale score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale score (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'accelerometer'], 'conditions': ['Ischemic Stroke', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '25370584', 'type': 'DERIVED', 'citation': 'Strommen AM, Christensen T, Jensen K. Quantitative measurement of physical activity in acute ischemic stroke and transient ischemic attack. Stroke. 2014 Dec;45(12):3649-55. doi: 10.1161/STROKEAHA.114.006496. Epub 2014 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.\n\nStudies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.\n\nAccelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.\n\nAnother approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.\n\nClarification of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.\n\nThe purpose of the project is to describe the amount and pattern of physical activity in stroke patients in the first week after admission. The investigators hypothesis is that patients are inactive for most of the time during hospitalization, activity being correlated with severity of stroke, but not with age, BMI and sex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stroke admitted acutely to a hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted with acute ischemic stroke\n* age \\> 18 years\n\nExclusion Criteria:\n\n* symptoms attributable to other diseases than ischemic stroke\n* debut of symptoms \\> 48 h prior to admission\n* consent not given \\< 24 h of admission\n* pregnancy or lactation\n* isolation\n* bloodsampling generally not possible\n* allergy due to accelerometer wear\n* ulcers or other skin diseases in the area of accelerometer placement'}, 'identificationModule': {'nctId': 'NCT01560520', 'briefTitle': 'Physical Activity Immediately After Acute Cerebral Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much?', 'orgStudyIdInfo': {'id': '30704'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Accelerometer', 'interventionNames': ['Behavioral: Physical activity']}], 'interventions': [{'name': 'Physical activity', 'type': 'BEHAVIORAL', 'otherNames': ['actical, Actical'], 'description': 'Observation only', 'armGroupLabels': ['Accelerometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Hillerød Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Anna Maria Strømmen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurologic Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical assistant', 'investigatorFullName': 'Anna Maria Strømmen', 'investigatorAffiliation': 'Hillerod Hospital, Denmark'}}}}