Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Change in maximal oxygen uptake (VO2peak) (endurance training groups only)
研究概览
简要总结
The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.
详细描述
The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.
The TOP Study Part I aims at identifying the most appropriate way of individual intensity prescription. In a descriptive cross sectional study, 20 breast and 20 prostate cancer patients perform singe endurance and resistance training sessions prescribed by means of different methods of intensity prescription. The most appropriate method of intensity prescription is identified through considering predictability/homogeneity of physiological responses as well as perceived exertion and enjoyment.
The TOP Study Part II aims at investigating the most effective training method in terms of enhancing physical fitness for both endurance and strength training. The design is an exploratory four-arm 12-week randomized controlled training intervention trial in 60 breast and 60 prostate cancer patients. In two endurance arms, vigorous continuous training is compared to a polarized program consisting of moderate training and aerobic high intensity interval training (HIIT). Similarly, in two resistance training arms, standard machine based hypertrophy training is compared to training following a daily undulating periodization design.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with early stage breast cancer (M0) or prostate cancer (M0 or M1 with PSA evidence of stable disease)
- •6 to 52 weeks after the end of primary therapy
- •≥18 to 75 years of age
- •no regular endurance or resistance training (≥ one session per week) since diagnosis or within the last 6 months
- •sufficient German language skills
- •willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing
- •signed informed consent.
排除标准
- •diagnosed with additional other cancer
- •brain or bone metastases in M1 prostate cancer patients
- •heart failure >NYHA III, unstable angina pectoris or severe arrhythmia
- •uncontrolled hypertension
- •reduced standing or walking ability
- •any other comorbidities that preclude participation in exercise testing or training.
结局指标
主要结局
Change in maximal oxygen uptake (VO2peak) (endurance training groups only)
时间窗: 12 weeks
Change in maximal oxygen uptake (VO2peak) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer
Change in one repetition maximum (1RM) of the knee extensors (resistance training groups only)
时间窗: 12 weeks
Change in one repetition maximum (1RM) of the knee extensors in a machine based 1RM test
Change in maximal isokinetic peak torque (MIPT) of the knee extensors (resistance training groups only)
时间窗: 12 weeks
Change in maximal isokinetic peak torque (MIPT) of the knee extensors assessed in a stationary dynamometer test
次要结局
- Change in peak power output (PPO) (endurance training groups only)(12 weeks)
- Change in blood lactate threshold (endurance training groups only)(12 weeks)
- Change in ventilatory threshold (endurance training groups only)(12 weeks)
- Change in maximum voluntary isometric contraction (MVIC) of the knee extensors (resistance training groups only)(12 weeks)
- Change in total work (TW) of the knee extensors(12 weeks)
- Change in muscular fatigue index (FI%) of the knee extensors(12 weeks)
- Adherence to the training programs(12 weeks)
- Drop-out rate in the training groups(12 weeks)
- Pain during and between training sessions(12 weeks)
- Minor and major adverse events during training sessions(12 weeks)
- Changes in fatigue(12 weeks)
- Changes in Quality of Life (QoL)(12 weeks)
- Changes in depression(12 weeks)
- Enjoyment of the training programs(12 weeks)
研究者
Joachim Wiskemann
Principle Investigator
University Hospital Heidelberg