{
  "FullStudy":{
    "Rank":217648,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518660",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MS&PRT_SSAU_TK"
          },
          "Organization":{
            "OrgFullName":"University of Aarhus",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Multiple Sclerosis and Progressive Resistance Training",
          "OfficialTitle":"Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 1, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 2, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Aarhus",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Aarhus University Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Biogen",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Multiple Sclerosis (Relapsing Remitting)"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Resistance Training",
              "Strength Training"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"35",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Training",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Training"
                  ]
                }
              },{
                "ArmGroupLabel":"Control",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Training",
                "InterventionDescription":"Bi-weekly progressive resistance training",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Training"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Blood-borne biomarkers",
                "PrimaryOutcomeDescription":"Resting levels of bloodbourne biomarkers;\n\nCytokines\nNeurotrophins",
                "PrimaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Neuro-muscular function of knee extensors",
                "SecondaryOutcomeDescription":"By use of an isokinetic dynamometer, EMG and stimulation equipment the following will be assessed for the knee extensors;\n\nMaximal muscle strength\nSurface EMG\nCentral activation ratio",
                "SecondaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Walking performance",
                "SecondaryOutcomeDescription":"Walking performance will be assessed by the;\n\nTwo minute walk test\n25-foot walk test\nChair rise test\nStair climb test",
                "SecondaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Self-reported measures",
                "SecondaryOutcomeDescription":"The self-reported measures contains questionnaires regarding;\n\nFatigue (Fatigue Severity Scale, Modifies Fatigue Impact Scale)\nHealth-Related Quality of Life (SF-36)\nDepression (Major Depression Inventory)\nDisease impact (MS Impact Scale 29)\nWalking Performance (MS Walking Scale 12)",
                "SecondaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Brain volume",
                "SecondaryOutcomeDescription":"MRI-scans of the head will provide the following measurements;\n\nBrain volume (analysed with SIENA)\nPlaque incidence",
                "SecondaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Body Composition",
                "SecondaryOutcomeDescription":"Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)",
                "SecondaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Thigh muscle cross-sectional area",
                "SecondaryOutcomeDescription":"MRI-scans of the thigh will provide cross-sectional area of\n\nm. quadriceps\nm. hamstring",
                "SecondaryOutcomeTimeFrame":"Change from baseline to 24 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosed relapsing-remitting MS according to the McDonald criteria\nExpanded Disability Status Scale (EDSS) between 2.0 and 5.5\nBe able to train twice a week at the University\nUse interferon based medication\n\nExclusion Criteria:\n\nAlcohol abuse, Alzheimer`s and pacemaker (or other metallic implant)\nComorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases\nHaving had an attack in a period of 8 weeks prior to the start of the intervention period\nHaving an attack during the intervention period\nPregnancy\nSystematic resistance training in a period of 3 months prior to the start of the intervention period.\nTraining adherence of less than 85%.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Tue Kjølhede, M.Sc.",
                "OverallOfficialAffiliation":"Sport Science, Department of Public Health, Aarhus University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Ulrik Dalgas, Ph.D.",
                "OverallOfficialAffiliation":"Sport Science, Department of Public Health, Aarhus University",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Kristian Vissing, Ph.D.",
                "OverallOfficialAffiliation":"Sport Science, Department of Public Health, Aarhus University",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Thor Petersen, Dr.med",
                "OverallOfficialAffiliation":"MS Clinic, Department of Neurology, Aarhus University Hospital",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"MS Clinic, Department of Neurology, Aarhus University Hospital",
                "LocationCity":"Aarhus C",
                "LocationZip":"8000",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Sport Science, Aarhus University",
                "LocationCity":"Aarhus C",
                "LocationZip":"8000",
                "LocationCountry":"Denmark"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009103",
                "ConditionMeshTerm":"Multiple Sclerosis"
              },{
                "ConditionMeshId":"D000012598",
                "ConditionMeshTerm":"Sclerosis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000020278",
                "ConditionAncestorTerm":"Demyelinating Autoimmune Diseases, CNS"
              },{
                "ConditionAncestorId":"D000020274",
                "ConditionAncestorTerm":"Autoimmune Diseases of the Nervous System"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000003711",
                "ConditionAncestorTerm":"Demyelinating Diseases"
              },{
                "ConditionAncestorId":"D000001327",
                "ConditionAncestorTerm":"Autoimmune Diseases"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M10643",
                "ConditionBrowseLeafName":"Multiple Sclerosis",
                "ConditionBrowseLeafAsFound":"Multiple Sclerosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13998",
                "ConditionBrowseLeafName":"Sclerosis",
                "ConditionBrowseLeafAsFound":"Sclerosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3210",
                "ConditionBrowseLeafName":"Autoimmune Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20682",
                "ConditionBrowseLeafName":"Demyelinating Autoimmune Diseases, CNS",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20678",
                "ConditionBrowseLeafName":"Autoimmune Diseases of the Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5492",
                "ConditionBrowseLeafName":"Demyelinating Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}