[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581435":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":25,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":25,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Brisk walking group","EXPERIMENTAL","Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes\u002Fsession, three sessions\u002Fweek).",[13],"Behavioral: Brisk walking",{"label":15,"type":16,"description":17,"interventionNames":18},"CBT-I group","ACTIVE_COMPARATOR","Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session\u002Fweek).",[19],"Behavioral: Cognitive-behavioral therapy for insomnia",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Brisk walking",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Cognitive-behavioral therapy for insomnia",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Zixin Wang, PhD","CONTACT","+852 22528474","wangzx@cuhk.edu.hk",[36],{"facility":37,"status":25,"city":38,"state":25,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The Chinese University of Hong Kong","Hong Kong","HK",{"type":41,"coordinates":42},"Point",[43,44],114.17469,22.27832,{"lat":44,"lon":43},[47],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Zixin Wang","Assistant Professor","100581435","brisk-walking-training-compared-with-cognitive-behavioral-therapy-for-the-treatment-of-chronic-primary-insomnia-in-people-aged-60-years-or-above-a-randomized-partially-blinded-non-inferiority-trial-100581435",false,"NCT06850272","Brisk Walking Training Compared with Cognitive Behavioral Therapy for the Treatment of Chronic Primary Insomnia in People Aged 60 Years or Above: a Randomized, Partially Blinded, Non-inferiority Trial","Inclusion Criteria:\n\n1. Aged ≥60 years;\n2. Ethnic Chinese; able to read, write and speak Cantonese\n3. Having a Hong Kong ID;\n4. Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2.\n5. Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)\n6. Experiencing any one of the following symptoms for ≥3 days per week\n\n   1. Difficulty initiating sleep; OR\n   2. Difficulty maintaining sleep; OR\n   3. Early-morning awakening with inability to return to sleep\n\nExclusion Criteria:\n\n1. Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);\n2. Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes\u002Fsession);\n3. Currently receiving or scheduled to receive CBT-I during the study period;\n4. Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).\n5. Working nightshifts and unable\u002Funwilling to discontinue such work pattern;\n6. Having a diagnosis of a major depressive disorder, anxiety disorders or other severe mental disorder (bipolar disorders, psychosis). Those with mild depression or anxiety disorders will not be excluded;\n7. Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;\n8. Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).\n9. Having a serious somatic condition preventing the participation of brisk walking training\u002FCBT-I.","ALL","60 Years",{"count":61,"type":62},92,"ESTIMATED","INTERVENTIONAL",[65],"NA","This study is a single-blinded (outcome assessor) and parallel-group non-inferiority RCT. Chinese older adults aged ≥60 years with chronic primary insomnia will be randomized evenly (1:1) to either the brisk walking training group or the CBT-I group. Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes\u002Fsession, three sessions\u002Fweek). Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session\u002Fweek). Self-reported and objective sleep outcomes are measured at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).",[68],"Primary Insomnia","NOT_YET_RECRUITING","2025-02-23",{"date":72,"type":73},"2025-02-27","ACTUAL",{"date":75,"type":62},"2025-03-10",{"date":77,"type":62},"2026-09-30",{"name":5,"class":6},1]