Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-07 @ 7:19 AM
Study NCT ID:
NCT03259932
Status:
WITHDRAWN
Last Update Posted:
2024-02-28
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, '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'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study could not be set up due to recruitment and feasibility problems', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue relief (assessed by the Fatigue Severity Scale)', 'timeFrame': '4 months after the stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '34695300', 'type': 'DERIVED', 'citation': 'Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.'}]}, 'descriptionModule': {'briefSummary': 'After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* National health insurance cover\n* 1st minor ischaemic stroke (initial NIH score ≤ 4)\n* Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)\n* Patient living close to the participating centre (\\<50 km)\n* With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))\n\nExclusion Criteria:\n\n* haemorrhagic stroke\n* History of ischaemic or haemorrhagic stroke with clinical manifestations\n* History of TIA\n* MMS ≤ 24\n* Pre-existing dementia (defined according to DSM IV criteria)\n* Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible\n* Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)\n* Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion\n* Pre-stroke Rankin score ≥ 3\n* Pregnant patient\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT03259932', 'acronym': 'FRAM', 'briefTitle': 'Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'GREMEAUX PHRC I 2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'usual management', 'interventionNames': ['Other: no physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'physical training', 'interventionNames': ['Other: physical activity']}], 'interventions': [{'name': 'no physical activity', 'type': 'OTHER', 'description': 'no physical activity', 'armGroupLabels': ['usual management']}, {'name': 'physical activity', 'type': 'OTHER', 'description': 'Rehabilitation program will start 4 weeks after discharge from acute care (S4), for a duration of 8 weeks (3 sessions / week). Physical training will include aerobic exercises 30-60 minutes at 50-80% of HRmax, associated with muscle building exercises in circuit training (20 min), and balance and flexibility exercises.', 'armGroupLabels': ['physical training']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}