[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536011":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":36,"locations":44,"responsibleParty":62,"collaborators":18,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":18,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Copenhagen University Hospital at Herlev","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Patients in the intervention group will receive a 32-week exercise-based intervention that includes supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.",[13],"Behavioral: High intensity high impact exercise intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","High intensity high impact exercise intervention","Patients in the intervention group will receive a 32-week exercise-based intervention that includes:\n\n\\- Supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.",[9],[26,29,33],{"name":27,"affiliation":5,"role":28},"Anne-Mette Ragle, PhD student","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":32},"Peter B Østergren","Peter Østergren","STUDY_DIRECTOR",{"name":34,"affiliation":35,"role":32},"Katharina Leuchte, Dr. med.","University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)",[37,41],{"name":27,"role":38,"phone":39,"phoneExt":18,"email":40},"CONTACT","+4527128044","anne-mette.ragle@regionh.dk",{"name":42,"role":38,"phone":18,"phoneExt":18,"email":43},"Peter Busch Østergren, MD, PhD","peter.busch.oestergren@regionh.dk",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Herlev and Gentofte Hospital","RECRUITING","Herlev","2730","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],12.43998,55.72366,{"lat":56,"lon":55},[59,60],{"name":27,"role":38,"phone":39,"phoneExt":18,"email":40},{"name":61,"role":38,"phone":18,"phoneExt":18,"email":43},"Peter B Østergren, MD PhD",{"type":28,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Anne-Mette Ragle","Principal Investigator","100536011","high-impact-training-to-patients-with-prostate-cancer-and-bone-metastases-100536011",false,"NCT06259279","High Impact Training to Patients with Prostate Cancer and Bone Metastases","HIP","Inclusion Criteria:\n\n* Patients with metastatic hormone sensitive prostate cancer (mHSPC)\n* Patients must have bone metastases according to the most recent imaging (Bone scan, CT, MRI and\u002For PET)\n* Patients must be treated with androgen deprivation therapy (ADT) (orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist treatment) started \\\u003C 12 months ago. Additional treatment in the mHSPC setting, i.e., radiotherapy (RT) of the prostate, novel hormone agents (NHA) and\u002For docetaxel is permitted\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score \\\u003C2\n* Patients must be able to speak and read Danish and provide a signed informed consent form\n* Patients must be ambulatory without walking aids\n\nExclusion Criteria:\n\n* Patients with any physical condition that interferes with the performance of physical exercise training\n* Patients with presence of any musculoskeletal, cardiovascular, or neurologic conditions that may prevent patients from exercising\n* Patients with bone pain requiring opioids\n* Patients with planned or prior palliative radiation therapy to the bone\n* Patients with major surgery within the past 6 months\n\nHIPimmune: all patients included in HIP are eligible for HIPimmune","MALE","18 Years",{"count":75,"type":76},102,"ESTIMATED","INTERVENTIONAL",[79],"NA","HIP is a randomized controlled trial. The aim is investigate the effect, safety and feasibility of brief, high-impact exercise targeting bones in patients with prostate cancer and bone metastases. Furthermore, to investigate the effects of the intervention on bone status (bone mineral density) and body composition, physical function and performance, patient reported quality-of-life outcomes, falls and hospitalizations. The effects of resistance training on the antitumor immunity will be assessed in the peripheral blood and tumor biopsies (HIPimmune).",[82],"Prostate Cancer",[84,85,86,87,88],"bone metastases","exercise","bone mineral density","resistance and impact training","antitumor immunity","2025-02-10",{"date":91,"type":92},"2025-02-13","ACTUAL",{"date":94,"type":92},"2024-02-06",{"date":96,"type":76},"2026-12-31",{"name":5,"class":6},1]