Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-01 @ 1:49 AM
Study NCT ID:
NCT02731235
Status:
UNKNOWN
Last Update Posted:
2022-09-07
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Aerobic Exercise in Patients With Lacunar Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059409', 'term': 'Stroke, Lacunar'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}], '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': 'D000083244', 'term': 'Thrombotic Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardio-vascular event or death', 'timeFrame': '5 years', 'description': 'Follow-up 5 years from inclusion on cardiovascular events or death'}], 'primaryOutcomes': [{'measure': "Difference in the 'Graded Cycling Test with Talk Test'", 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'Sub-maximal exercise test on a stationary bicycle'}], 'secondaryOutcomes': [{'measure': 'Endothelial response', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'measurement of endothelial response by Endopat2000'}, {'measure': 'Physical Activity Scale (PAS)', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'A questionnaire that measures the level of self-reported physical activity'}, {'measure': 'Short time activity measurements', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'Accelerometer (Axivity) to short time registration of physical activity (24 hours in an 8 day period (after inclusion, before 3 months visit, before 12 month visit)'}, {'measure': 'The WHO-five Well-being Index (WHO-5)', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'A questionnaire that measures current mental well-being'}, {'measure': 'Montreal Cognitive Assessment (MOCA)', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'A cognitive screening test for detection of mild cognitive impairments'}, {'measure': 'Major Depression Inventory (MDI)', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'A self-report mood questionnaire'}, {'measure': 'Multidimensional Fatigue Inventory (MFI-20)', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'A 20-item self-report instrument designed to measure fatigue.'}, {'measure': 'Ull-Meter', 'timeFrame': 'At baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': "An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress."}, {'measure': 'Blood samples', 'timeFrame': 'at baseline, 3 (primary analysis), 6 and 12 months after baseline testing', 'description': 'Blood samples to determine cardiovascular risk factors'}, {'measure': 'Magnetic resonance Imaging (MRI)', 'timeFrame': '12 months after baseline testing', 'description': 'Detection of new infarcts or white matter lesions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'stroke, acute', 'Cerebral small vessel disease'], 'conditions': ['Stroke, Lacunar']}, '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.'}, {'pmid': '31316451', 'type': 'DERIVED', 'citation': 'Steen Krawcyk R, Vinther A, Petersen NC, Faber J, Iversen HK, Christensen T, Lambertsen KL, Rehman S, Klausen TW, Rostrup E, Kruuse C. Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. Front Neurol. 2019 Jun 28;10:664. doi: 10.3389/fneur.2019.00664. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.', 'detailedDescription': 'Little is known about effect of exercise for patients with lacunar stroke, no studies have investigated the feasibility or effect of aerobic exercise in this subgroup of stroke. The patients have few and temporary symptoms and are therefore early discharged from the hospital. After an cerebral infarct the patients have increased risk of recurrent stroke and they are at risk of developing cognitive deficits or vascular dementia over time. Researchers want to investigate if high-intensity training at home in the acute phase has an effect on aerobic fitness, endothelial response and health profile in this potential fragile group of patients. We hope to increase the patients´ physical and mental function, and thereby prevent a recurrent stroke and slow the progression of vascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lacunar stroke verified by clinical examination and CT- or MRI-scans\n* able to speak and read Danish\n\nExclusion Criteria:\n\n* previous large artery stroke,\n* symptoms or co-morbidities in the musculoskeletal system, which hinder bicycling,\n* dyspnoea caused by heart or pulmonary disease,\n* aphasia or dementia which hinder completion of the Talk Test.\n\nAmendment 1 (version 4.0, June 2016) has been modified to allow an extended inclusion period from 0-21 days (previously 0-7 days).\n\nAlso, to allow inclusion of patients with recurrent lacunar stroke, with clinical symptoms and a corresponding ischemic lesion on MRI.\n\nAmendment 2 (version 5.0, June 2017) has allowed inclusion from two other stroke units in the Capital Region of Copenhagen due to low recruitment rate. The article describes protocol version 5.0 from June 6th. 2017'}, 'identificationModule': {'nctId': 'NCT02731235', 'acronym': 'HITPALS', 'briefTitle': 'The Effect of Aerobic Exercise in Patients With Lacunar Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'High-intensity Training in Patients With Lacunar Stroke (HITPALS)', 'orgStudyIdInfo': {'id': 'H-15012371'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Prophylactic stroke medication and recommendations for lifestyle changes', 'interventionNames': ['Drug: prophylactic stroke medication', 'Behavioral: Recommendations for lifestyle changes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks', 'interventionNames': ['Other: High-intensity training', 'Drug: prophylactic stroke medication', 'Behavioral: Recommendations for lifestyle changes']}], 'interventions': [{'name': 'High-intensity training', 'type': 'OTHER', 'description': 'high intensity training 5 days a week for 12 weeks', 'armGroupLabels': ['Exercise']}, {'name': 'prophylactic stroke medication', 'type': 'DRUG', 'description': 'Usual care medication for stroke prophylaxis', 'armGroupLabels': ['Control', 'Exercise']}, {'name': 'Recommendations for lifestyle changes', 'type': 'BEHAVIORAL', 'description': 'Advise on diet, alcohol, smoking and exercise', 'armGroupLabels': ['Control', 'Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital, Dept Neurology', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Christina Kruuse, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital, Dept Neurology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Association of Danish Physiotherapists', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, consultant neurologist', 'investigatorFullName': 'Christina Kruuse', 'investigatorAffiliation': 'Herlev Hospital'}}}}