Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-02 @ 8:09 AM
Study NCT ID:
NCT01718392
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2012-10-23', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin sensitivity (insulin profile)', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'glucose and insulin concentration measurements in blood'}], 'secondaryOutcomes': [{'measure': 'aerobic capacity', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'by means of a submaximal endurance test (ergometer)'}, {'measure': 'aerobic capacity - lactate concentrations', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)'}, {'measure': 'cytokine profile', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'measurements of blood cytokine levels'}, {'measure': 'walking performance', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'Walking performance will be assessed by means of 2 and 6 minute walk test, 25-foot walk test, Chair rise test, Stair climb test'}, {'measure': 'Self-reported measures', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'The self-reported measures contains some questionnaires'}, {'measure': 'body composition', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan'}, {'measure': 'muscle strength of knee flexor', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'by means of an isokinetic dynamometer the muscle strength and endurance will be measured'}, {'measure': 'muscle strength of knee extensor', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'by means of an isokinetic dynamometer the muscle strength and endurance will be measured'}, {'measure': 'muscle strength of elbow flexor', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'by means of an isokinetic dynamometer the muscle strength will be measured'}, {'measure': 'muscle strength of elbow extensor', 'timeFrame': 'change from baseline to 24 weeks', 'description': 'by means of an isokinetic dynamometer the muscle strength will be measured'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['combined training', 'insulin resistance'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to investigate the development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed MS according to the McDonald criteria\n* Expanded Disability Status Scale (EDSS) between 0.5 and 6\n* Be able to train 5 times in 2 weeks at the University\n\nExclusion Criteria:\n\n* Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2)\n* Having had an relapse in a period of 3 months prior to the start of the intervention period\n* Having an relapse during the intervention period\n* Pregnancy and other contra indications for physical activity\n* Mental disorders'}, 'identificationModule': {'nctId': 'NCT01718392', 'briefTitle': 'Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'orgStudyIdInfo': {'id': 'CME 2011/311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': '24 weeks combined exercise programme (supervised)', 'interventionNames': ['Behavioral: Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'sedentary/habitual lifestyle'}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'otherNames': ['24 weeks combined exercise programma (supervised)'], 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3590', 'city': 'Diepenbeek', 'country': 'Belgium', 'facility': 'REVAL', 'geoPoint': {'lat': 50.90769, 'lon': 5.41875}}], 'overallOfficials': [{'name': 'Inez Wens, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reval/Biomed, Hasselt University'}, {'name': "Bert Op't Eijnde, Ph.D.", 'role': 'STUDY_CHAIR', 'affiliation': 'Reval/Biomed, Hasselt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Bert Op't Eijnde", 'investigatorAffiliation': 'Hasselt University'}}}}