High-intensity resistance and impact training for patients with hormone-sensitive prostate cancer and bone metastases-study protocol of a randomized clinical trial

BACKGROUND: Men with metastatic prostate cancer are at an increased risk of metabolic syndrome, cardiovascular disease, and pathological fracture. The latter is both attributed to the cancer itself, bones are the most common site of metastases in prostate cancer, as well as the treatment with androgen deprivation therapy. Exercise therapy has been shown to be beneficial, but with uncertainty about its safety, applicability, and suitability for patients with prostate cancer and bone metastases. In these patients, we aim to investigate the safety and efficacy of exercise therapy that specifically targets bone in terms of bone density in the legs.

METHODS/DESIGN: This blinded, randomized, controlled trial will include 102 patients with prostate cancer and bone metastases. Participants will be assigned to a supervised 32-week high-intensity progressive resistance and impact training program (intervention group) or standard treatment including a municipal 12-week standard training program, if desired (control group). Primary outcomes are changes in physical capacity and lower extremity strength measured by the 30-s Chair Stand Test. Secondary outcomes include bone mineral density and body composition, physical function, quality of life, safety (i.e., adverse events and pain), hospitalizations, physical activity, falls, feasibility, and patient experiences. Data will be collected at baseline, midway intervention (16 weeks), post-intervention (32 weeks), and follow-up (44 weeks).

DISCUSSION: This study is the first to examine a long-term high-intensity progressive resistance and impact training in patients with prostate cancer and bone metastases. While exercise recommendations for these patients have typically been cautious, high-intensity progressive resistance and impact training has demonstrated safety and benefit in patients with osteoporosis. This research will shed light on the efficacy and safety of progressive resistance and impact training in patients with prostate cancer and bone metastases, potentially improving treatment-related side effects and quality of life.

TRIAL REGISTRATION: This trial is approved by the Regional Ethics Committee for the Capital Region of Denmark (J.nr.:H-23015286) and by the Danish Data Protection Agency (j.nr.: P-2023-2018). The study was prospectively registered at ClinicalTrials.gov on February 24, 2024 (ID: NCT06259279).