[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536011":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":97,"studyPopulation":86,"armGroups":98,"interventions":109,"overallOfficials":115,"centralContacts":126,"locations":134,"responsibleParty":152,"collaborators":86,"id":155,"slug":86,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":156,"sex":161,"minAge":162,"maxAge":86,"enrollmentInfo":163,"targetDuration":86,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":137,"whyStopped":86,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Copenhagen University Hospital at Herlev","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":86},[9],{"measure":10,"description":11,"timeFrame":12},"Lower body strength measured with the 30-second chair stand test (30s-CST)","Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assesment will be conducted by blinded physiotherapist","baseline, 16 weeks, 32 weeks and 44 weeks",[14,18,20,22,24,26,28,30,32,34,36,38,40,43,47,50,54,57,60,63,66,69,72,75,78,82],{"measure":15,"description":16,"timeFrame":17},"Fat free mass (kg)","Measured with DXA scans","Change measures baseline, 32 weeks",{"measure":19,"description":16,"timeFrame":17},"Body fat (% and kg)",{"measure":21,"description":16,"timeFrame":17},"Whole Body (BMC, g)",{"measure":23,"description":16,"timeFrame":17},"Whole Body (BMD, g\u002Fcm2)",{"measure":25,"description":16,"timeFrame":17},"Whole body T-score",{"measure":27,"description":16,"timeFrame":17},"Lumbar spine (L1-L4 BMD, g\u002Fcm2)",{"measure":29,"description":16,"timeFrame":17},"Lumbar spine T-score",{"measure":31,"description":16,"timeFrame":17},"Total Hip BMD, g\u002Fcm2",{"measure":33,"description":16,"timeFrame":17},"Total hip T-score Os Calcis BMD, g\u002Fcm2 Os calcis T-score",{"measure":35,"description":16,"timeFrame":17},"Total hip T-score",{"measure":37,"description":16,"timeFrame":17},"Os Calcis BMD, g\u002Fcm2",{"measure":39,"description":16,"timeFrame":17},"Os calcis T-score",{"measure":41,"description":42,"timeFrame":12},"Handgrip strength","Handgrip strength grip test, (measured in Kg, higher score is better outcome)",{"measure":44,"description":45,"timeFrame":46},"Quality of life (QOL)","Measured with the Functional Assessment of Cancer Therapy-Prostate. the questionnaire is divided into several sub-topics, and it differs from topic to topic whether a high score is best. Minimum score:0 and maximum score 4","Change measures baseline, 16 weeks, 32 weeks and 44 weeks",{"measure":48,"description":49,"timeFrame":46},"Fatigue","Measured with the Functional Assessment of Chronic Illness Therapy - Fatigue Scale. Low score is a better outcome the minimum score is 0, maximum score is 4",{"measure":51,"description":52,"timeFrame":53},"Safety (adverse events)","Safety is measured by registration of bone fracture grade \\> 2 according to Common Terminology Criteria for Adverse Events (CTCAE) grading criteria. Adverse events as musculoskeletal grade \\> 2 including pain, or cardiac disorders according to CTCAE, and sprains requiring medical treatment.\n\nGrade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age, appropriate instrumental ADL\\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\\*\\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.","Through study completion, an average of 1 year",{"measure":55,"description":56,"timeFrame":53},"Hospitalizations","Registration of hospital admissions in number",{"measure":58,"description":59,"timeFrame":53},"Hospitalizations, causes","Registration of causes for hospital admissions",{"measure":61,"description":62,"timeFrame":53},"Hospitalizations, length of hospitalizations","Registration of hospital admissions in days",{"measure":64,"description":65,"timeFrame":53},"Falls","Participants will be asked to report incidence of any falls in the project period . Falls requiring treatment will be registered as adverse events and be reported according to CTCAE.",{"measure":67,"description":68,"timeFrame":53},"Feasibility measured by dropout","Feasibility is assessed by dropout in the study",{"measure":70,"description":71,"timeFrame":53},"Feasibility measured by recruitment","Feasibility is assessed by recruitment, numbers of included patients compared to number of eligible patients",{"measure":73,"description":74,"timeFrame":53},"Feasibility measured by adherence.","Feasibility is assessed by adherence. How many times the patients participate in the execise sessions . Numbers from 0-64. Higher score is better.",{"measure":76,"description":77,"timeFrame":46},"Physical activity","Data of daily physical activity will be assessed in the intervention period using the Physical Activity Scale 2 (PAS -2), which measure physical activity levels",{"measure":79,"description":80,"timeFrame":81},"Qualitative assessment of patients' experiences","Qualitative individual semi-structured interviews with participants from the intervention group","Up to 6 months after study completion",{"measure":83,"description":84,"timeFrame":85},"HIPimmune: Immune response in peripheral blood and tumor","Flow-cytometric analysis of circulating immune cell frequencies (T, B, NK cells and myeloid cells) longitudinally during the study period, both before and after the exercise intervention (in the intervention arm). Additionally, prostate biopsies around week 32 will be stained by immunohistochemistry for infiltrating immune cells (T and NK cells).","Baseline, week 8, week 32, week 44",null,{"allocation":88,"interventionModel":89,"interventionModelDescription":90,"primaryPurpose":91,"observationalModel":86,"timePerspective":86,"maskingInfo":92},"RANDOMIZED","PARALLEL","RCT","SUPPORTIVE_CARE",{"masking":93,"maskingDescription":94,"whoMasked":95},"SINGLE","Testers of physical tests (Handgrip strength test and chair-stand-test) and the the statistician will be blinded for allocation.",[96],"OUTCOMES_ASSESSOR","Participants assigned to the intervention group will participate in a 32-week, twice-weekly, 30-minute, supervised HIP program at the hospital in Herlev, Denmark. To ensure a safe transition to high-intensity exercise, the first eight weeks of the intervention includes self-bodyweight and low-impact variations with a focus on getting used to use weight training equipment and gradually learning the movement patterns of the HIP exercises. All participants should be able to perform the four basic exercises of the intervention within two months. The resistance exercises (deadlift, overhead press, and squats) will be performed in five sets of five repetitions for the remaining intervention period, maintaining an intensity of \\> 80% to 85% of 1 repetition maximum (RM). Blood samples and tumor biopsies will be taken at different timepoints of the exercise intervention (HIPimmune) and analyzed for lymphocyte entitumor responses.",[99,105],{"label":100,"type":101,"description":102,"interventionNames":103},"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.",[104],"Behavioral: High intensity high impact exercise intervention",{"label":106,"type":107,"description":108,"interventionNames":86},"Control Group","NO_INTERVENTION","standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.",[110],{"type":111,"name":112,"description":113,"armGroupLabels":114,"otherNames":86},"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.",[100],[116,119,123],{"name":117,"affiliation":5,"role":118},"Anne-Mette Ragle, PhD student","PRINCIPAL_INVESTIGATOR",{"name":120,"affiliation":121,"role":122},"Peter B Østergren","Peter Østergren","STUDY_DIRECTOR",{"name":124,"affiliation":125,"role":122},"Katharina Leuchte, Dr. med.","University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)",[127,131],{"name":117,"role":128,"phone":129,"phoneExt":86,"email":130},"CONTACT","+4527128044","anne-mette.ragle@regionh.dk",{"name":132,"role":128,"phone":86,"phoneExt":86,"email":133},"Peter Busch Østergren, MD, PhD","peter.busch.oestergren@regionh.dk",[135],{"facility":136,"status":137,"city":138,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":147,"contacts":148},"Herlev and Gentofte Hospital","RECRUITING","Herlev","2730","Denmark","DK",{"type":143,"coordinates":144},"Point",[145,146],12.43998,55.72366,{"lat":146,"lon":145},[149,150],{"name":117,"role":128,"phone":129,"phoneExt":86,"email":130},{"name":151,"role":128,"phone":86,"phoneExt":86,"email":133},"Peter B Østergren, MD PhD",{"type":118,"investigatorFullName":153,"investigatorTitle":154,"investigatorAffiliation":5,"oldNameTitle":86,"oldOrganization":86},"Anne-Mette Ragle","Principal Investigator","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":164,"type":165},102,"ESTIMATED","INTERVENTIONAL",[168],"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).",[171],"Prostate Cancer",[173,174,175,176,177],"bone metastases","exercise","bone mineral density","resistance and impact training","antitumor immunity","2025-02-10",{"date":180,"type":181},"2025-02-13","ACTUAL",{"date":183,"type":181},"2024-02-06",{"date":185,"type":165},"2026-12-31",{"name":5,"class":6},1]