{
  "FullStudy":{
    "Rank":218130,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512342",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PacingCFS"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"Artesis University College",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Artesis University College Antwerp"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Vrije Universiteit Brussel",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome",
          "OfficialTitle":"Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome: Randomized Controlled Clinical Trial"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 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":"Artesis University College, Antwerp",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Universiteit Antwerpen",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"University Hospital, Antwerp",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS 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 CFS.",
          "DetailedDescription":"Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS 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 CFS.\n\nAccording to the power calculation, 36 patients fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome (CFS) 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.\n\nOutcome measures include the Canadian Occupational Performance Measure (COPM), Medical Outcomes Short Form 37 Health Status Survey (SF-36), Checklist Individual Strength (CIS), CFS Symptom List and autonomic activity at rest and following 3 activities of daily living (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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Fatigue Syndrome"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "pacing",
              "activity management",
              "relaxation",
              "physiotherapy",
              "occupational therapy",
              "autonomic nervous system"
            ]
          }
        },
        "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":"33",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Pacing",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"The pacing self-management program focussed 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), CFS 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 therapy",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Relaxation therapy comprised of education about the role of stress in CFS 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 therapy"
                  ]
                }
              }
            ]
          },
          "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",
                    "adaptive pacing"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"relaxation therapy",
                "InterventionDescription":"3 one-on-one sessions weekly for 3 consecutive weeks",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "relaxation therapy"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "stress managament",
                    "Jacobson relaxation",
                    "visualisation",
                    "Schultz relaxation"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"the change in score on the Canadian Occupational Performance Measure (COPM)",
                "PrimaryOutcomeDescription":"well-validated, reliable and frequently used outcome measure 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 and it is the most frequently used measure in CFS research.",
                "SecondaryOutcomeTimeFrame":"measured at baseline (week 1) and post-treatment (week 5)"
              },{
                "SecondaryOutcomeMeasure":"the change in Ckecklist 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 at baseline (week 1) and post-treatment (week 5)"
              },{
                "SecondaryOutcomeMeasure":"the change in CFS Symptom List",
                "SecondaryOutcomeDescription":"The CFS Symptom List is a self-reported measure for assessing symptom severity in CFS patients. In order to assess the severity of the symptoms included in the CFS Symptom List, visual analogue scales (100 mm) are used. Psychometric work supporting the use of the CFS Symptom List has been published.",
                "SecondaryOutcomeTimeFrame":"measured at baseline (week 1) and post-treatment (week 5)"
              },{
                "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 at baseline (week 1) and post-treatment (week 5)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nadult\nage range between 18 and 65 years of age\nfemale gender\nwilling to sign informed consent form\nfulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome\n\nExclusion Criteria:\n\n- Not fulfilling each of the inclusion criteria listed above.",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Daphne Kos, PhD",
                "OverallOfficialAffiliation":"Artesis University College Antwerp, Belgium",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Hospital Antwerp",
                "LocationCity":"Antwerp",
                "LocationZip":"B-2650",
                "LocationCountry":"Belgium"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"20104421",
                "ReferenceType":"background",
                "ReferenceCitation":"Nijs J, van Eupen I, Vandecauter J, Augustinus E, Bleyen G, Moorkens G, Meeus M. Can pacing self-management alter physical behavior and symptom severity in chronic fatigue syndrome? A case series. J Rehabil Res Dev. 2009;46(7):985-96."
              },{
                "ReferencePMID":"18382818",
                "ReferenceType":"background",
                "ReferenceCitation":"Nijs J, Paul L, Wallman K. Chronic fatigue syndrome: an approach combining self-management with graded exercise to avoid exacerbations. J Rehabil Med. 2008 Apr;40(4):241-7. doi: 10.2340/16501977-0185."
              },{
                "ReferencePMID":"22032215",
                "ReferenceType":"background",
                "ReferenceCitation":"Meeus M, van Eupen I, van Baarle E, De Boeck V, Luyckx A, Kos D, Nijs J. Symptom fluctuations and daily physical activity in patients with chronic fatigue syndrome: a case-control study. Arch Phys Med Rehabil. 2011 Nov;92(11):1820-6. doi: 10.1016/j.apmr.2011.06.023."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"International Pain in Motion research group",
                "SeeAlsoLinkURL":"http://www.paininmotion.be"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000015673",
                "ConditionMeshTerm":"Fatigue Syndrome, Chronic"
              },{
                "ConditionMeshId":"D000013577",
                "ConditionMeshTerm":"Syndrome"
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                "ConditionMeshId":"D000005221",
                "ConditionMeshTerm":"Fatigue"
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                "ConditionAncestorId":"D000004194",
                "ConditionAncestorTerm":"Disease"
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                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
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                "ConditionAncestorTerm":"Virus Diseases"
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                "ConditionAncestorTerm":"Muscular Diseases"
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                "ConditionAncestorTerm":"Musculoskeletal Diseases"
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                "ConditionAncestorTerm":"Encephalomyelitis"
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                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
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                "ConditionBrowseLeafAsFound":"Syndrome",
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                "ConditionBrowseLeafName":"Fatigue",
                "ConditionBrowseLeafAsFound":"Fatigue",
                "ConditionBrowseLeafRelevance":"high"
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                "ConditionBrowseLeafId":"M16843",
                "ConditionBrowseLeafName":"Fatigue Syndrome, Chronic",
                "ConditionBrowseLeafAsFound":"Chronic Fatigue Syndrome",
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                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
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}