Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALHigh intensity high impact exercise interventionPatients 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.