Trials / Recruiting
RecruitingNCT06259279
High Impact Training to Patients with Prostate Cancer and Bone Metastases
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- Copenhagen University Hospital at Herlev · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | High intensity high impact exercise intervention | 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. |
Timeline
- Start date
- 2024-02-06
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-02-14
- Last updated
- 2025-02-13
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06259279. Inclusion in this directory is not an endorsement.