ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximal leg strength
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT).
The main questions it aims to answer are:
- How feasible and safe is the new training concept?
- How efficient is the training concept to counteract side effects caused by ADT?
Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects.
Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.
详细描述
Detailed description of the training concept applied in the intervention:
The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences. The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24, 20 s intervals on a Monark cycle ergometer. The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block. When a participant manages to perform all 3 blocks with 8 intervals in each block (a total of 24 intervals) the resistance will be increased by ~20 W. The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min. The starting workload of the intervals will be individually adjusted to ~115 % of the participant's power output at VO2peak. The total duration of a training session will be 30-40 min (including worm-up).
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •histologically confirmed localised or locally advanced prostate cancer
- •planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis.
排除标准
- •very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
- •localized prostate cancer planned for radiotherapy without ADT
- •on-going or previously treated with ADT or other hormonal treatments
- •have any contraindications to physical testing/exercise as per the ACSM guidelines
- •unable to comply with study procedures
结局指标
主要结局
Maximal leg strength
时间窗: Baseline and after 6 and 12 weeks
Isometric squat test (N) measured on force plates
Aerobic fitness
时间窗: Baseline and after 6 and 12 weeks
VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
次要结局
- Body fat(Baseline and after 6 and 12 weeks)
- Walk capacity(Baseline and after 6 and 12 weeks)
- Whole body glucose uptake(Baseline and after 6 and 12 weeks)
- Whole body insulin response(Baseline and after 6 and 12 weeks)
- Quadriceps cross-sectional area(Baseline and after 6 and 12 weeks)
- Lean body mass(Baseline and after 6 and 12 weeks)
- Bone mineral density(Baseline and after 6 and 12 weeks)
- Mitochondrial respiration(Baseline and after 12 weeks)
- Blood biomarkers related to cardiovascular disease.(Baseline and after 6 and 12 weeks)
- Muscle fiber cross-sectional area (CSA)(Baseline and after 12 weeks)
- Physical and psychological health(Baseline and after 6 and 12 weeks)
- Static balance(Baseline and after 6 and 12 weeks)
- Lower body muscular endurance(Baseline and after 6 and 12 weeks)
- Blood pressure(Baseline and after 6 and 12 weeks)
- Capillary content(Baseline and after 12 weeks)
- Satellite cell content(Baseline and after 12 weeks)
- Anxiety and depression(Baseline and after 6 and 12 weeks)
- Cancer and treatment-related fatigue(Baseline and after 6 and 12 weeks)
- Myonuclei content(Baseline and after 12 weeks)
- Transcriptome-wide RNA expression(Baseline and after 12 weeks)
- Gene expression(Baseline and after 12 weeks)
- Physical activity(Baseline and after 6 and 12 weeks)
- Muscle fiber distribution(Baseline and after 12 weeks)
- Protein expression(Baseline and after 12 weeks)
- Cancer treatment-related symptoms(Baseline and after 6 and 12 weeks)
- Mitochondrial content(Baseline and after 12 weeks)
- Genome-wide DNA methylation(Baseline and after 12 weeks)