{
  "FullStudy":{
    "Rank":217916,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515163",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Lupus and exercise"
          },
          "Organization":{
            "OrgFullName":"University of Sao Paulo",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Exercise and Systemic Lupus Erythematosus"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2016",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2016",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 12, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 13, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Bruno Gualano",
            "ResponsiblePartyInvestigatorTitle":"PhD, Assistant Professor",
            "ResponsiblePartyInvestigatorAffiliation":"University of Sao Paulo"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Sao Paulo",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Systemic Lupus Erythematosus"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"90",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Exercise",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"3-month exercise training program",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Exercise training"
                  ]
                }
              },{
                "ArmGroupLabel":"Control",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Control group"
              },{
                "ArmGroupLabel":"Healthy control",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Exercise training"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Exercise training",
                "InterventionDescription":"Aerobic exercise training, two times a week",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Exercise",
                    "Healthy control"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl)",
                "PrimaryOutcomeTimeFrame":"3 months"
              },{
                "PrimaryOutcomeMeasure":"Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp",
                "PrimaryOutcomeTimeFrame":"3 months"
              },{
                "PrimaryOutcomeMeasure":"Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml)",
                "PrimaryOutcomeTimeFrame":"3 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Cardiovascular parameters",
                "SecondaryOutcomeDescription":"Aerobic capacity, chronotropic function",
                "SecondaryOutcomeTimeFrame":"3 months"
              },{
                "SecondaryOutcomeMeasure":"Muscle Strength",
                "SecondaryOutcomeDescription":"Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol",
                "SecondaryOutcomeTimeFrame":"3 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge between 7 and 40 years\nSLEDAI ≤ 4\n\nExclusion Criteria:\n\nCardiovascular dysfunction\nRhythm and conduction disorders\nMusculoskeletal disturbances\nKidney and pulmonary involvements\nPeripheral neuropathy\nUse of tobacco\nTreatment with lipid-lowering or hypoglycemic drugs\nFibromyalgia\nUse of chronotropic or antihypertensive drugs\nPhysically active subjects",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"7 Years",
          "MaximumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Sao Paulo",
                "LocationCity":"Sao Paulo",
                "LocationState":"SP",
                "LocationZip":"05403-000",
                "LocationCountry":"Brazil"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29755474",
                "ReferenceType":"derived",
                "ReferenceCitation":"Benatti FB, Miyake CNH, Dantas WS, Zambelli VO, Shinjo SK, Pereira RMR, Silva MER, Sá-Pinto AL, Borba E, Bonfá E, Gualano B. Exercise Increases Insulin Sensitivity and Skeletal Muscle AMPK Expression in Systemic Lupus Erythematosus: A Randomized Controlled Trial. Front Immunol. 2018 Apr 27;9:906. doi: 10.3389/fimmu.2018.00906. eCollection 2018."
              },{
                "ReferencePMID":"24972700",
                "ReferenceType":"derived",
                "ReferenceCitation":"Benatti FB, Miossi R, Passareli M, Nakandakare ER, Perandini L, Lima FR, Roschel H, Borba E, Bonfá E, Gualano B, de Sá Pinto AL. The effects of exercise on lipid profile in systemic lupus erythematosus and healthy individuals: a randomized trial. Rheumatol Int. 2015 Jan;35(1):61-9. doi: 10.1007/s00296-014-3081-4. Epub 2014 Jun 28."
              },{
                "ReferencePMID":"23531226",
                "ReferenceType":"derived",
                "ReferenceCitation":"Prado DM, Benatti FB, de Sá-Pinto AL, Hayashi AP, Gualano B, Pereira RM, Sallum AM, Bonfá E, Silva CA, Roschel H. Exercise training in childhood-onset systemic lupus erythematosus: a controlled randomized trial. Arthritis Res Ther. 2013 Mar 26;15(2):R46. doi: 10.1186/ar4205."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008180",
                "ConditionMeshTerm":"Lupus Erythematosus, Systemic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003240",
                "ConditionAncestorTerm":"Connective Tissue Diseases"
              },{
                "ConditionAncestorId":"D000001327",
                "ConditionAncestorTerm":"Autoimmune Diseases"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9760",
                "ConditionBrowseLeafName":"Lupus Erythematosus, Systemic",
                "ConditionBrowseLeafAsFound":"Systemic Lupus Erythematosus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5047",
                "ConditionBrowseLeafName":"Connective Tissue Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3210",
                "ConditionBrowseLeafName":"Autoimmune Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}