{
  "FullStudy":{
    "Rank":218131,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512329",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PaceMS"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"Artesis University College",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Artesis University College Antwerp PWO"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Vrije Universiteit Brussel",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Pacing Activity Self-management for Patients With Multiple Sclerosis",
          "OfficialTitle":"Pacing Activity Self-management for Patients With Multiple Sclerosis: Randomized Controlled Clinical Trial"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 16, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 17, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jo Nijs",
            "ResponsiblePartyInvestigatorTitle":"associate professor",
            "ResponsiblePartyInvestigatorAffiliation":"Vrije Universiteit Brussel"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Vrije Universiteit Brussel",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University Hospital, Antwerp",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Universiteit Antwerpen",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Artesis University College, Antwerp",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (MS), it is examined whether physical behavior and health status of patients with MS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with MS.",
          "DetailedDescription":"Up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (MS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Multiple Sclerosis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "neurology",
              "physiotherapy",
              "physical therapy",
              "occupational therapy",
              "stress management",
              "activity management",
              "treatment"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"31",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"pacing",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"The pacing self-management program (3 one-on-one sessions weekly for 3 consecutive weeks) focused on teaching the patient to estimate their current physical capabilities prior to commencing an activity. In order to appropriately pace activities (daily activities and exercise bouts), MS patients were learned to estimate their current physical capabilities prior to commencing an activity, keeping in mind the regular fluctuating nature of their symptoms. The activity duration used within the program was less than that reported by the patient so to account for typical overestimations made by the patient. Each activity block was interspersed with breaks, with the length of this break equating to the duration of the activity.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: pacing"
                  ]
                }
              },{
                "ArmGroupLabel":"relaxation",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Relaxation therapy (3 one-on-one sessions weekly for 3 consecutive weeks) comprised of education about the role of stress in MS biology, and the opportunities stress management provides to handle this issue. Patients were then taught how to apply stress management techniques like Jacobson relaxation skills, Schultz relaxation skills, visualization, etc.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: relaxation"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"pacing",
                "InterventionDescription":"3 one-on-one sessions weekly for 3 consecutive weeks",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "pacing"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "activity self-management",
                    "activity management"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"relaxation",
                "InterventionDescription":"3 one-on-one sessions weekly for 3 consecutive weeks",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "relaxation"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Schultz relaxation",
                    "visualisation",
                    "Jacobson relaxation",
                    "stress management"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"the change in scores obtained from the Canadian Occupational Performance Measure (COPM)",
                "PrimaryOutcomeDescription":"Semi-structered interview.",
                "PrimaryOutcomeTimeFrame":"measured at baseline (week 1) and post-treatment (week 5)"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)",
                "SecondaryOutcomeDescription":"The SF-36 assesses functional status and well-being or quality of life. The SF-36 has been documented to have reliability and validity in a wide variety of patient populations.",
                "SecondaryOutcomeTimeFrame":"measured once at baseline and once post-treatment"
              },{
                "SecondaryOutcomeMeasure":"the change in subscale scores on the Checklist Individual Strength (CIS)",
                "SecondaryOutcomeDescription":"The CIS aims at assessing the subjective fatigue experience, concentration difficulties, motivation and physical activity. Higher scores on the CIS correspond to severe fatigue, many concentration difficulties, problems with motivation and a low level of physical activity. Its psychometric properties are well established.",
                "SecondaryOutcomeTimeFrame":"measured once at baseline and once post-treatment"
              },{
                "SecondaryOutcomeMeasure":"the change in autonomic activity at rest and following 3 activities of daily living",
                "SecondaryOutcomeDescription":"The 3 activities of daily living entail writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs. For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.",
                "SecondaryOutcomeTimeFrame":"measured once at baseline and once post-treatment"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nadult\nage range between 18 and 65 years of age\nwilling to sign informed consent form\nfulfilling the criteria for the diagnosis of multiple sclerosis\n\nExclusion Criteria:\n\n- Not fulfilling each of the inclusion criteria listed above.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jo Nijs, PhD",
                "OverallOfficialAffiliation":"Artesis University College, Antwerp",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Daphne Kos, PhD",
                "OverallOfficialAffiliation":"Artesis University College, Antwerp",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Nationaal Multiple Sclerosis Centrum",
                "LocationCity":"Melsbroek",
                "LocationCountry":"Belgium"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"17453852",
                "ReferenceType":"background",
                "ReferenceCitation":"Kos D, Nagels G, D'Hooghe MB, Duquet W, Ilsbroukx S, Delbeke S, Kerckhofs E. Measuring activity patterns using actigraphy in multiple sclerosis. Chronobiol Int. 2007;24(2):345-56."
              },{
                "ReferencePMID":"16916440",
                "ReferenceType":"background",
                "ReferenceCitation":"Kos D, Nagels G, D'Hooghe MB, Duportail M, Kerckhofs E. A rapid screening tool for fatigue impact in multiple sclerosis. BMC Neurol. 2006 Aug 17;6:27."
              },{
                "ReferencePMID":"17623738",
                "ReferenceType":"background",
                "ReferenceCitation":"Kos D, Duportail M, D'hooghe M, Nagels G, Kerckhofs E. Multidisciplinary fatigue management programme in multiple sclerosis: a randomized clinical trial. Mult Scler. 2007 Sep;13(8):996-1003. Epub 2007 Jul 10."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"International Pain in Motion research group",
                "SeeAlsoLinkURL":"http://www.paininmotion.be"
              }
            ]
          }
        }
      },
      "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"
              }
            ]
          }
        }
      }
    }
  }
}