Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT01518660
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Sclerosis and Progressive Resistance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2012-01-06', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood-borne biomarkers', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'Resting levels of bloodbourne biomarkers;\n\n* Cytokines\n* Neurotrophins'}], 'secondaryOutcomes': [{'measure': 'Neuro-muscular function of knee extensors', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'By use of an isokinetic dynamometer, EMG and stimulation equipment the following will be assessed for the knee extensors;\n\n* Maximal muscle strength\n* Surface EMG\n* Central activation ratio'}, {'measure': 'Walking performance', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'Walking performance will be assessed by the;\n\n* Two minute walk test\n* 25-foot walk test\n* Chair rise test\n* Stair climb test'}, {'measure': 'Self-reported measures', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'The self-reported measures contains questionnaires regarding;\n\n* Fatigue (Fatigue Severity Scale, Modifies Fatigue Impact Scale)\n* Health-Related Quality of Life (SF-36)\n* Depression (Major Depression Inventory)\n* Disease impact (MS Impact Scale 29)\n* Walking Performance (MS Walking Scale 12)'}, {'measure': 'Brain volume', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'MRI-scans of the head will provide the following measurements;\n\n* Brain volume (analysed with SIENA)\n* Plaque incidence'}, {'measure': 'Body Composition', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)'}, {'measure': 'Thigh muscle cross-sectional area', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'MRI-scans of the thigh will provide cross-sectional area of\n\n* m. quadriceps\n* m. hamstring'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Resistance Training', 'Strength Training'], 'conditions': ['Multiple Sclerosis (Relapsing Remitting)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.', 'detailedDescription': 'Exercise in general, and progressive resistance training (PRT) in particular, is regarded as an important tool in the rehabilitation of people with multiple sclerosis (MS).\n\nPrevious studies have reported positive effects of PRT on muscle strength, functional capacity, fatigue and quality of life. Also, a possible disease modifying effect has been proposed. However, the underlying physiological mechanisms that might explain these beneficial effects and the possible effects on disease progression are unresolved. Additionally, none of the previous studies has been concerned with the possible impact of MS progression type, gender and/or medication.\n\nThe purpose of this randomized, controlled, gender stratified trial is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed relapsing-remitting MS according to the McDonald criteria\n* Expanded Disability Status Scale (EDSS) between 2.0 and 5.5\n* Be able to train twice a week at the University\n* Use interferon based medication\n\nExclusion Criteria:\n\n* Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)\n* Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases\n* Having had an attack in a period of 8 weeks prior to the start of the intervention period\n* Having an attack during the intervention period\n* Pregnancy\n* Systematic resistance training in a period of 3 months prior to the start of the intervention period.\n* Training adherence of less than 85%."}, 'identificationModule': {'nctId': 'NCT01518660', 'briefTitle': 'Multiple Sclerosis and Progressive Resistance Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training', 'orgStudyIdInfo': {'id': 'MS&PRT_SSAU_TK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'interventionNames': ['Behavioral: Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'description': 'Bi-weekly progressive resistance training', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'MS Clinic, Department of Neurology, Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Sport Science, Aarhus University', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Tue Kjølhede, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sport Science, Department of Public Health, Aarhus University'}, {'name': 'Ulrik Dalgas, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sport Science, Department of Public Health, Aarhus University'}, {'name': 'Kristian Vissing, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sport Science, Department of Public Health, Aarhus University'}, {'name': 'Thor Petersen, Dr.med', 'role': 'STUDY_CHAIR', 'affiliation': 'MS Clinic, Department of Neurology, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}