[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551516":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":72,"collaborators":52,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":52,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":102,"whyStopped":52,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"IRCCS Centro San Giovanni di Dio Fatebenefratelli","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Participants will engage in a 12-week structured PA programme, preceded by three weekly psychoeducational sessions focused on nutrition. This includes three 60-minute PA sessions per week supervised by a personal trainer.",[13,14],"Behavioral: Structured Physical Activity Programme","Behavioral: Psychoeducational Programme",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Participants will receive a 12-week psychoeducational programme on nutrition and PA. This programme includes 8 sessions divided into modules of 2 or 3 lessons each, covering topics such as the benefits of PA and sports, healthy eating habits, and health risks associated with a sedentary lifestyle. Sessions will be conducted by a dietitian and a clinical psychologist. At the end of the trial, control group participants will be offered the opportunity to participate in the same PA programme as the intervention group at no cost.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Structured Physical Activity Programme","A somatic examination will also be conducted by a sports physician, which will include the assessment of muscle strength, cardiorespiratory fitness, walking gait, blood pressure, and body mass index (BMI). Based on this evaluation, the sports physician will design a personalised physical activity programme for the participants in the intervention group.",[9],[27],"Physical Activity",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Psychoeducational Programme","The control group undergoes a 12-week psychoeducational programme on nutrition and PA, consisting of 8 sessions. Led by a dietitian and psychologist, topics include PA benefits, healthy eating, and sedentary lifestyle risks. The experimental group receives 3 sessions on dietary habits before starting PA intervention, ensuring differentiation. It's expected the experimental group directly benefits from exercise, while the control group benefits from PA education. At the trial's end, control group members can join the PA programme for free.",[16,9],[33,34],"Psychoeducation","Psychoeducation Intervention",[36],{"name":37,"affiliation":38,"role":39},"Giovanni de Girolamo, MD","IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy","PRINCIPAL_INVESTIGATOR",[41,46],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","030-3501590","0039","gdegirolamo@fatebenefratelli.eu",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Silvia Leone, PsyD","030-3501333","sleone@fatebenefratelli.eu",[51],{"facility":5,"status":52,"city":53,"state":52,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},null,"Brescia","25125","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],10.21472,45.53558,{"lat":61,"lon":60},[64,66,67,70],{"name":37,"role":42,"phone":65,"phoneExt":44,"email":45},"030 3501590",{"name":37,"role":39,"phone":52,"phoneExt":52,"email":52},{"name":68,"role":69,"phone":52,"phoneExt":52,"email":52},"Silvia Leone, M.Sc.","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":52,"phoneExt":52,"email":52},"Miriam D'Addazio, M.Sc.",{"type":73,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100551516","physical-activity-in-people-with-borderline-personality-disorder-pabord-100551516",false,"NCT06461104","Physical Activity in People With Borderline Personality Disorder (PABORD)","Physical Activity in People With Borderline Personality Disorder (PABORD): a Study Protocol for a Pilot Randomised Controlled Trial (RCT)","PABORD","Inclusion Criteria:\n\n* Female gender.\n* Age between 18 and 40 years.\n* Primary diagnosis of Borderline Personality Disorder (BPD) according to the diagnostic criteria of the DSM-5.\n* Outpatient treatment.\n* Ability to provide written informed consent.\n* Good understanding of the Italian language.\n* Proficiency in using a smartphone.\n* The presence of ongoing pharmacological and\u002For psychotherapeutic treatments is not considered an exclusion criterion.\n\nExclusion Criteria:\n\n* Current pregnancy or planning a pregnancy within the next 6 months.\n* Acute psychotic symptoms.\n* Comorbidities with Eating Disorders, Substance Use Disorder, and Bipolar Disorder.\n* Absolute contraindications to physical exercise, such as medical conditions that interfere with the ability to perform exercise or with the physiological response to exercise tests, e.g., the use of beta-adrenergic blocking agents.","FEMALE","18 Years","40 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:\n\n1. Does a structured PA program reduce clinical symptoms in patients with BPD?\n2. How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?\n\nParticipants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).\n\nResearchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).",[93],"Borderline Personality Disorder",[27,93,95,96,97,98,99,100,101],"ESM","Females","Global Functioning","Accelerometer","Motivation","Premenstrual Syndrome","Outpatients","NOT_YET_RECRUITING","2024-06-11",{"date":105,"type":106},"2024-06-14","ACTUAL",{"date":108,"type":87},"2024-09-01",{"date":110,"type":87},"2025-04-01",{"name":5,"class":6},1]