Nctid:
NCT06226779
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012559", "term"=>"Schizophrenia"}], "ancestors"=>[{"id"=>"D019967", "term"=>"Schizophrenia Spectrum and Other Psychotic Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M15376", "name"=>"Schizophrenia", "asFound"=>"Schizophrenia", "relevance"=>"HIGH"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M21838", "name"=>"Schizophrenia Spectrum and Other Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-18", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change score of the Brief Assessment of Cognition in Schizophrenia (BACS)", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"BACS is a battery of cognition tests that measure verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function.The BACS is comprised of seven subtests: (1) the List Learning Test, (2) Digit Sequencing Test, (3) Token Motor Test, (4) Category Instance Test, (5) Controlled Oral Word Association Test, (6) Symbol Coding, and (7) Tower of London Test."}, {"measure"=>"Change scores of 6-minute walk test", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"This test evaluates cardiovascular fitness and walking speed."}, {"measure"=>"Change scores of 30-second chair stand test", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"This test evaluates muscular endurance of lower-extremities."}, {"measure"=>"Change scores of Timed up-and-go test", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"This test evaluates functional mobility, agility and balance"}, {"measure"=>"Change scores of dual task Timed up-and-go test (manual)", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance."}, {"measure"=>"Change scores of dual task Timed up-and-go test (cognitive)", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance."}], "secondaryOutcomes"=>[{"measure"=>"Change score of Depression, Anxiety Stress Scales-21 (DASS-21)", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"DASS-21 is a self-report questionnaire that measure symptoms of depression, anxiety, and stress."}, {"measure"=>"Change score of Pittsburg Sleep Quality Index", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"PSQI is a self-report assessment which contains 19 items to measure sleep quality"}, {"measure"=>"Change score of Euro-Qol 5-Dimmensions (EQ-5D).", "timeFrame"=>"Baseline, immediate after treatment, 4-week follow up", "description"=>"EQ-5D is a self-reporting questionnaire that measures five dimensions of health state: (1) mobility, (2) self-care, (3)usual activities, (4) pain/discomfort, and (5) anxiety/depression."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["schizophrenia, mindful exercise, exercise, cognition"], "conditions"=>["Schizophrenia", "Exercise", "Condition"]}, "descriptionModule"=>{"briefSummary"=>"The current study intends to recruit participants with schizophrenia for the practice of Baduanjin, brisk walking, and health education after enrollment. The study also including a maintenance program. Cognitive and physical function assessments will be conducted before, after, and during follow-up tests. The research hypothesis posits that both Baduanjin and brisk walking will confer beneficial effects on various aspects of cognitive and physical functions.", "detailedDescription"=>"Cognitive function deficits are core features in patients with schizophrenia. These deficits need active intervention to prevent functional decline. Baduanjin and brisk walking show promise as interventions in patients with schizophrenia. This study investigated the effects of Baduanjin exercise versus brisk walking in patients with schizophrenia.\n\nThis study will be a single-blind, 3-arm, parallel, randomized controlled trial.\n\nA total of 120 patients with schizophrenia will be enrolled and randomly assigned to the Baduanjin group, brisk walking group or control group. The intervention group will practice Badunjin exercise. While participants in brisk walking group will receive brisk walking at the same duration. The controls will watch videos that are not aimed at improving physical exertion. Maintenance programs will also be conducted for participants to encourage practicing in exercise after intervention. All group will undergo evaluation at three time points: baseline, immediately after intervention and 4-week follow up after intervention. The primary outcome will be cognitive function and physical function. Secondary outcomes will include mood, sleep quality, and quality of live."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"20 years", "genderBased"=>true, "genderDescription"=>"Based on self-representation of gender identity.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Having a diagnosis of schizophrenia according to the DSM-5.\n2. Who will be above 20-65 years of age .\n3. Having a stable mental status without shift in medication and keep in same dose for at least one month.\n4. Being able to walk independently for 50 meters.\n\nExclusion Criteria:\n\n1. Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.\n2. Visual or auditory impairment that precludes completion of assessment.\n3. Acute psychosis requiring hospitalization.\n4. Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions."}, "identificationModule"=>{"nctId"=>"NCT06226779", "briefTitle"=>"Baduanjin Versus Brisk Walking for Cognition in Schizophrenia", "organization"=>{"class"=>"OTHER", "fullName"=>"Chang Gung Memorial Hospital"}, "officialTitle"=>"Mindful Exercise Baduanjin Versus Brisk Walking for Cognitive Function in Patients With Schizophrenia", "orgStudyIdInfo"=>{"id"=>"202400006B0"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Baduanjin", "description"=>"Parcipants will practice baduanjin exercise.", "interventionNames"=>["Behavioral: Baduanjin exercsie"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Brisk walking", "description"=>"Parcipants will perform brisk walking activities.", "interventionNames"=>["Behavioral: Brisk walking"]}, {"type"=>"OTHER", "label"=>"health education", "description"=>"Parcipants will receive health education classes and watch sport related videos.", "interventionNames"=>["Behavioral: Health education"]}], "interventions"=>[{"name"=>"Baduanjin exercsie", "type"=>"BEHAVIORAL", "otherNames"=>["Mindful baduanjin"], "description"=>"The Baduanjin exercise consists of 8 postures, with emphasis on different body parts. The exercise is commonly practiced as follows: (1) 2 hands holding up the heavens, (2) drawing the bow to shoot the eagle, (3) separating the heaven and earth, (4) wise owl gazing backwards, (5) swaying the head and shaking the tail, (6) 2 hands holding the feet to strengthen the waist, (7) clenching the fists and glaring fiercely, and (8) bouncing on the toes.", "armGroupLabels"=>["Baduanjin"]}, {"name"=>"Brisk walking", "type"=>"BEHAVIORAL", "otherNames"=>["aerobic walking"], "description"=>"The brisk walking will be gradually increased physical exertion from light to moderate of intensity. During the training period, the heart rate of participants will be monitored.", "armGroupLabels"=>["Brisk walking"]}, {"name"=>"Health education", "type"=>"BEHAVIORAL", "otherNames"=>["video watching"], "description"=>"Health education will include lecture classes. Video watching will watch videos which were not aim at improving physical exertion, such as sports games or sports related variety shows", "armGroupLabels"=>["health education"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"833", "city"=>"Kaohsiung", "status"=>"RECRUITING", "country"=>"Taiwan", "contacts"=>[{"name"=>"Chyi-Rong Chen, Master", "role"=>"CONTACT", "email"=>"ccr776@cgmh.org.tw", "phone"=>"+886-7-7317123", "phoneExt"=>"8755"}, {"name"=>"Tzu-Ting Chen, Master", "role"=>"CONTACT", "email"=>"tracy5824@hotmail.com", "phone"=>"+886-7-7317123", "phoneExt"=>"8755"}], "facility"=>"Chang Gung Memorial Hospital, Kaohsiung Medical Center", "geoPoint"=>{"lat"=>22.61626, "lon"=>120.31333}}], "centralContacts"=>[{"name"=>"Chyi-Rong Chen, Master", "role"=>"CONTACT", "email"=>"ccr776@cgmh.org.tw", "phone"=>"886-7-7317123", "phoneExt"=>"8755"}, {"name"=>"Keh-chung Lin, Doctor", "role"=>"CONTACT", "email"=>"kehchunglin@ntu.edu.tw", "phone"=>"886-2-33668180"}], "overallOfficials"=>[{"name"=>"Chen Chyi-Rong, Master", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Chang gung memorial hospital, Kaohsiung branch"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Chang Gung Memorial Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Occupational therapist", "investigatorFullName"=>"Chen Chyi-Rong", "investigatorAffiliation"=>"Chang Gung Memorial Hospital"}}}}
