Clinical trial · Interventional
High Impact Training to Patients with Prostate Cancer and Bone Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High intensity high impact exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 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.
- interventionNames
- Behavioral: High intensity high impact exercise intervention
- type
- NO_INTERVENTION
- label
- Control Group
- description
- standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.
Primary outcomes (1)
- measure
- Lower body strength measured with the 30-second chair stand test (30s-CST)
- timeFrame
- baseline, 16 weeks, 32 weeks and 44 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic hormone sensitive prostate cancer (mHSPC) * Patients must have bone metastases according to the most recent imaging (Bone scan, CT, MRI and/or PET) * Patients must be treated with androgen deprivation therapy (ADT) (orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist treatment) started \< 12 months ago. Additional treatment in the mHSPC setting, i.e., radiotherapy (RT) of the prostate, novel hormone agents (NHA) and/or docetaxel is permitted * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score \<2 * Patients must be able to speak and read Danish and provide a signed informed consent form * Patients must be ambulatory without walking aids Exclusion Criteria: * Patients with any physical condition that interferes with the performance of physical exercise training * Patients with presence of any musculoskeletal, cardiovascular, or neurologic conditions that may prevent patients from exercising * Patients with bone pain requiring opioids * Patients with planned or prior palliative radiation therapy to the bone * Patients with major surgery within the past 6 months HIPimmune: all patients included in HIP are eligible for HIPimmune
References
Publications (1)
- DERIVEDRagle AM, Mikkelsen MK, Vinther A, Zerahn B, Bogh Juhl C, Theile S, Madsen K, Nielsen DL, Ostergren PB. High-intensity resistance and impact training for patients with hormone-sensitive prostate cancer and bone metastases-study protocol of a randomized clinical trial. Trials. 2025 Jul 28;26(1):259. doi: 10.1186/s13063-025-08937-0. PMID 40722114