High Impact Training to Patients with Prostate Cancer and Bone Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Lower body strength measured with the 30-second chair stand test (30s-CST)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Testers of physical tests (Handgrip strength test and chair-stand-test) and the the statistician will be blinded for allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Lower body strength measured with the 30-second chair stand test (30s-CST)
时间窗: baseline, 16 weeks, 32 weeks and 44 weeks
Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assesment will be conducted by blinded physiotherapist
次要结局
- Fat free mass (kg)(Change measures baseline, 32 weeks)
- Body fat (% and kg)(Change measures baseline, 32 weeks)
- Whole Body (BMC, g)(Change measures baseline, 32 weeks)
- Whole Body (BMD, g/cm2)(Change measures baseline, 32 weeks)
- Whole body T-score(Change measures baseline, 32 weeks)
- Lumbar spine (L1-L4 BMD, g/cm2)(Change measures baseline, 32 weeks)
- Lumbar spine T-score(Change measures baseline, 32 weeks)
- Total Hip BMD, g/cm2(Change measures baseline, 32 weeks)
- Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score(Change measures baseline, 32 weeks)
- Total hip T-score(Change measures baseline, 32 weeks)
- Os Calcis BMD, g/cm2(Change measures baseline, 32 weeks)
- Os calcis T-score(Change measures baseline, 32 weeks)
- Handgrip strength(baseline, 16 weeks, 32 weeks and 44 weeks)
- Quality of life (QOL)(Change measures baseline, 16 weeks, 32 weeks and 44 weeks)
- Fatigue(Change measures baseline, 16 weeks, 32 weeks and 44 weeks)
- Hospitalizations, length of hospitalizations(Through study completion, an average of 1 year)
- Safety (adverse events)(Through study completion, an average of 1 year)
- Hospitalizations(Through study completion, an average of 1 year)
- Hospitalizations, causes(Through study completion, an average of 1 year)
- Falls(Through study completion, an average of 1 year)
- Feasibility measured by dropout(Through study completion, an average of 1 year)
- Feasibility measured by recruitment(Through study completion, an average of 1 year)
- Feasibility measured by adherence.(Through study completion, an average of 1 year)
- Physical activity(Change measures baseline, 16 weeks, 32 weeks and 44 weeks)
- Qualitative assessment of patients' experiences(Up to 6 months after study completion)
- HIPimmune: Immune response in peripheral blood and tumor(Baseline, week 8, week 32, week 44)
研究者
Anne-Mette Ragle
Principal Investigator
Copenhagen University Hospital at Herlev