High Impact Training to Patients with Prostate Cancer and Bone Metastases

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Lower body strength measured with the 30-second chair stand test (30s-CST) [Срок оценки: baseline, 16 weeks, 32 weeks and 44 weeks]

Вторичные конечные точки (12)

• Fat free mass (kg) [Срок оценки: Change measures baseline, 32 weeks]
• Body fat (% and kg) [Срок оценки: Change measures baseline, 32 weeks]
• Whole Body (BMC, g) [Срок оценки: Change measures baseline, 32 weeks]
• Whole Body (BMD, g/cm2) [Срок оценки: Change measures baseline, 32 weeks]
• Whole body T-score [Срок оценки: Change measures baseline, 32 weeks]
• Lumbar spine (L1-L4 BMD, g/cm2) [Срок оценки: Change measures baseline, 32 weeks]
• Lumbar spine T-score [Срок оценки: Change measures baseline, 32 weeks]
• Total Hip BMD, g/cm2 [Срок оценки: Change measures baseline, 32 weeks]
• Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score [Срок оценки: Change measures baseline, 32 weeks]
• Total hip T-score [Срок оценки: Change measures baseline, 32 weeks]
• Os Calcis BMD, g/cm2 [Срок оценки: Change measures baseline, 32 weeks]
• Os calcis T-score [Срок оценки: Change measures baseline, 32 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 1 центр

• Herlev and Gentofte Hospital — Herlev

Публикации

• Ragle 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

Идентификаторы

NCT: NCT06259279 · AMRagle

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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