{
  "FullStudy":{
    "Rank":218042,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513486",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MEC 11-3-073"
          },
          "Organization":{
            "OrgFullName":"Maastricht University Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Electrical Stimulation During Immobilization",
          "OfficialTitle":"The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men",
          "Acronym":"ESDIM"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 20, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 22, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Lex Verdijk",
            "ResponsiblePartyInvestigatorTitle":"Assistant Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Maastricht University Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Maastricht University Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Disuse Atrophy",
              "Immobilization",
              "Neuromuscular Electrical Stimulation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"24",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Immobilization with NMES",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Immobilization with daily NMES",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: immobilization"
                  ]
                }
              },{
                "ArmGroupLabel":"Immobilization without NMES",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Immobilization without daily NMES",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: immobilization"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"immobilization",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Immobilization with NMES",
                    "Immobilization without NMES"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"muscle mass, muscle fiber size",
                "PrimaryOutcomeTimeFrame":"three days before immobilization, and directly after immobilization (day of cast removal; day 6)"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension",
                "SecondaryOutcomeTimeFrame":"three days before immobilization, and directly after immobilization (day of cast removal; day 6)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMale\nAged from 18-35 years\n18.5 < BMI < 30 kg/m2\n\nExclusion Criteria:\n\nSmoking\nPerforming regular resistance training in the previous 6 months\nHypertension (according to WHO criteria) [46] and/or cardiovascular disease\nAny back/leg/knee/shoulder complaints which may interfere with the use of crutches\nUse of any prescribed medication\nType 2 diabetes mellitus\nAny family history of thrombosis\nAll co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).\nMyocardial infarction within the last 3 years\nUse of anti-coagulants",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"35 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Luc JC van Loon, PhD",
                "OverallOfficialAffiliation":"Maastricht UMC",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Maastricht University Medical Centre",
                "LocationCity":"Maastricht",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000020966",
                "ConditionMeshTerm":"Muscular Disorders, Atrophic"
              },{
                "ConditionMeshId":"D000001284",
                "ConditionMeshTerm":"Atrophy"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020763",
                "ConditionAncestorTerm":"Pathological Conditions, Anatomical"
              },{
                "ConditionAncestorId":"D000009135",
                "ConditionAncestorTerm":"Muscular Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              },{
                "ConditionAncestorId":"D000009468",
                "ConditionAncestorTerm":"Neuromuscular Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3170",
                "ConditionBrowseLeafName":"Atrophy",
                "ConditionBrowseLeafAsFound":"Atrophy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10675",
                "ConditionBrowseLeafName":"Muscular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21281",
                "ConditionBrowseLeafName":"Muscular Disorders, Atrophic",
                "ConditionBrowseLeafAsFound":"Disuse Atrophy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21103",
                "ConditionBrowseLeafName":"Pathological Conditions, Anatomical",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10994",
                "ConditionBrowseLeafName":"Neuromuscular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}