Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-04 @ 3:22 PM
Study NCT ID:
NCT04075968
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2019-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2019-08-11', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuro-psychometric Test (NPT)', 'timeFrame': '1 hour', 'description': 'It is a test that evaluates memory, working memory, planning, organization, attendance span.Evaluation is made according to the number of items filled. The higher number items filled indicates the better status'}, {'measure': 'Berg Balance Scale', 'timeFrame': '15 minutes', 'description': 'It is a scale which consists of 14 items. Each item is scored on a five-point scale (0-4).The maximum score for this assessment is 56 and the minimum score for this assessment is 0. Scores below 45 indicate balance impairment. The higher point indicates the better status'}, {'measure': 'Mini Mental State Test (MMST)', 'timeFrame': '10-15 minutes', 'description': 'It is a test that evaluates different subset of cognitive status including attention, memory, language, orientation, visuospatial proficiency. It is scored on a scale of 0-30 with scores. Scores above 25 are interpreted as normal cognitive status.'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': '3 minutes', 'description': 'The MAS is a 6-point rating scale which assesses muscle tone by manually manipulating the joint through its available range of motion and clinically recording the resistance to passive movements. The lower point indicates the better status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis. We assume that cognitive therapy is an effective treatment for multiple sclerosis.', 'detailedDescription': 'The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with definitive Multiple Sclerosis between 20-65 years, with an Mini Mental State Test score less than 24, with an Extended Disability Status Scale score less than 4, trained for at least 5 years, have not received steroid therapy in the last 1 month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an Mini Mental State Test score less than 24\n* Patients with an Extended Disability Status Scale score less than 4\n* Patients trained for at least 5 years\n* Patients who have not received steroid therapy in the last 1 month\n\nExclusion Criteria:\n\n* Patients who have not passed at least 3 months from the last Multiple Sclerosis attack\n* Patients with hearing and vision problems that may interfere with communication\n* The patients who Have other neurological and psychiatric disorder that will cause cognitive impairment\n* Patients receiving medical treatment for spasticity, tremor, bladder disorder and fatigue'}, 'identificationModule': {'nctId': 'NCT04075968', 'briefTitle': 'The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'The Effect of Cognitive Group Exercise Combined With Physical Exercise in Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': 'IstanbulPMRTRH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'exercise group; 6 weeks, twice a week, 30 minutes physical group exercises and 30 minutes general cognitive function exercises will be applied as groups.', 'interventionNames': ['Other: Cognitive exercise']}, {'label': 'group 2', 'description': 'control group; patients will be given physical and cognitive home exercise program individually.', 'interventionNames': ['Other: Home exercise']}], 'interventions': [{'name': 'Cognitive exercise', 'type': 'OTHER', 'description': 'Cognitive exercise will be applied', 'armGroupLabels': ['group 1']}, {'name': 'Home exercise', 'type': 'OTHER', 'description': 'Home exercise will be applied', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Arzu Esmeray', 'role': 'STUDY_CHAIR', 'affiliation': 'IstanbulPMHTRH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}