[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445113":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":104,"collaborators":106,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":25,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":25,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Lund University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aerobic exercise in group","EXPERIMENTAL","The patients will participate in aerobic group exercise for 60 minutes three times a week for 12 weeks with continuous heart rate monitoring. The sessions will be held in a small gym under supervision of a personal trainer.\n\nThe group training session will begin with a 3-5 minutes check-in round followed by a warm-up to increase heart rate including balance tasks and dynamic stretching for 10-15 minutes. Every third session will be pure aerobic training, every third session will be strengthening exercises designed to also increase heart rate, and every third session will be a mixed session of both aerobic and strength exercises. All major muscle groups will be used at each session. Interval training with gradually increased intensity throughout the program will be applied",[13],"Behavioral: Aerobic exercise in group",{"label":15,"type":16,"description":17,"interventionNames":18},"Leisure activities in group","ACTIVE_COMPARATOR","The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or cards together.",[19],"Behavioral: Leisure activities in group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The goal with every new week should be making every workout a little bit harder than the week before.\n\nStrength sessions\n\nWeek 1- 6: 12-18 repetitions (reps) x 2 set per exercise and muscle 30 seconds (s) rest between exercise Week 7-12: 10-12 reps x 3 set per exercise and muscle 20 s rest between exercises Adding weight with gym equipment or changing body position in the exercises to succeed with the rep scheme and making it harder as the group develop their physical and mental ability.\n\nConditioning sessions\n\nWeek 1- 6: 75 seconds work time x 1 set per exercise 30 seconds of rest between exercises Week 7-12: 50 seconds work time x 2 set per exercise 20 seconds of rest between exercises Mixed sessions\n\nWeek 1- 6: 35 s work time per exercise 25 s rest between exercises x 2 rounds Week 7-12: 45 s work time per exercise 15 s rest between exercises x 2 rounds",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or cards together",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Håkan Jarbin, MD, PhD","CONTACT","+46706778006","hakan.jarbin@regionhalland.se",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Rebecca Mortazavi, MD","+46738011091","rebecca.mortazavi@regionhalland.se",[40,61,78,88],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Region Halland","RECRUITING","Halmstad","30290","Sweden","SE",{"type":48,"coordinates":49},"Point",[50,51],12.85676,56.67446,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":56,"phoneExt":25,"email":34},"Håkan Jarbin, MD PhD","+64226961628",{"name":58,"role":32,"phone":59,"phoneExt":25,"email":60},"Henriette Nielsen","+46705104392","henriette.nielsen@regionhalland.se",{"facility":62,"status":42,"city":63,"state":25,"zip":64,"country":45,"countryCode":46,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Prima Barn och vuxenpsykiatri AB (Stockholm-Handen)","Stockholm","11846",{"type":48,"coordinates":66},[67,68],18.06871,59.32938,{"lat":68,"lon":67},[71,75],{"name":72,"role":32,"phone":73,"phoneExt":25,"email":74},"Åsa Mårsell, MD","+46705601222","asa.marsell@prima.se",{"name":76,"role":32,"phone":25,"phoneExt":25,"email":77},"Åsa Söderström, nurse","asa.soderstrom@prima.se",{"facility":79,"status":42,"city":63,"state":25,"zip":64,"country":45,"countryCode":46,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"PRIMA Barn och vuxenpsykiatri AB (Stockholm-Järva)",{"type":48,"coordinates":81},[67,68],{"lat":68,"lon":67},[84,85],{"name":72,"role":32,"phone":73,"phoneExt":25,"email":74},{"name":86,"role":32,"phone":25,"phoneExt":25,"email":87},"Sara Karlsson, social worker","sara.c.karlsson@prima.se",{"facility":41,"status":42,"city":89,"state":25,"zip":90,"country":45,"countryCode":46,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Varberg","43343",{"type":48,"coordinates":92},[93,94],12.25078,57.10557,{"lat":94,"lon":93},[97,101],{"name":98,"role":32,"phone":99,"phoneExt":25,"email":100},"Kristina Ingemarsson, MD","+46703807140","kristina.ingemarsson@regionhalland.se",{"name":102,"role":32,"phone":25,"phoneExt":25,"email":103},"Jessica Axheden","jessica.axheden@regionhalland.se",{"type":105,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[107,108,110,112,115,117],{"name":41,"class":6},{"name":109,"class":6},"Halmstad University",{"name":111,"class":6},"Karolinska University Hospital",{"name":113,"class":114},"The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden","UNKNOWN",{"name":116,"class":6},"Region Skane",{"name":118,"class":114},"PRIMA Barn- och Vuxenpsykiatri AB","100445113","aerobic-versus-leisure-group-for-adolescents-with-depression-100445113",false,"NCT05076214","Aerobic Versus Leisure Group for Adolescents With Depression","A Randomised Multicentre Study Comparing Vigorous Group Aerobic Exercise vs. Group Leisure Activities for Mild to Moderate Depression in Adolescents","Inclusion Criteria:\n\n* DSM-5 mild to moderate depression\n* who have received evaluation and basic psychosocial interventions for 4-8 weeks (minimum three visits) without response, i.e. not achieved improvement by at least 50 % as assessed from clinical records\n\nExclusion Criteria:\n\n* Severe depression\n* Eating disorder\n* High risk for suicide\n* Intellectual disability\n* Actual physical activity the last four weeks meeting the level for sustained health by American College of Sports Medicine, i.e. at least 150 min per week of moderate intensity or 75 min per week of high intensity38\n* Adjustment of antidepressant medication within the last four weeks or stimulants the last two weeks\n* Chronic somatic illness precluding exercise\n* In need of interpreter\n* Social circumstances interfering with a regular exercise schedule\n* Concomitant psychotherapy","ALL","13 Years","17 Years",{"count":130,"type":131},122,"ESTIMATED","INTERVENTIONAL",[134],"NA","The aim is to evaluate aerobic group exercise versus leisure group activities in adolescents with mild to moderate depression.\n\nPrimary outcome is Children's Depression Rating Scale - Revised (CDRS-R). Secondary outcomes are Clinical Global Impressions - Severity and Improvement scales (CGI), self-reported Quick Inventory of Depression Symptomatology (QIDS- A17-SR), the self-reported Outcome Rating Scale (ORS), clinician rated Children Global Assessment Scale (C-GAS), aerobic capacity (VO2max), muscular strength, body, Body Mass Index (BMI), presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples and a cost evaluation rated by parents with Trimbos\u002FiMTA questionnaire for Costs associated with Psychiatric Illness - Child version (Tic-P) and the Child Health Utility (CHU9D) to facilitate estimation of Quality Adjusted Life Years. Further objectives are qualitative interviews to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced and a validation of QIDS- A17-C and QIDS- A17-SR versus CDRS-R will be performed.",[137],"Depressive Disorder, Major",[139,140,141,142,143,144,145],"adolescent","depression","exercise intervention","leisure intervention","biomarker","cost evaluation","qualitative","2025-03-21",{"date":148,"type":149},"2025-03-26","ACTUAL",{"date":151,"type":149},"2022-02-28",{"date":153,"type":131},"2026-03-10",{"name":5,"class":6},4]