Cancer
Conditions
Keywords
Breast cancer, Prostate cancer, Exercise prescription, High intensity interval training, Daily undulating periodization training, Aerobic training, Resistance training, Physical fitness, Exercise
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard endurance training
Continuous vigorous training 2 x per week on a cycle ergometer
BEHAVIORALPolarized endurance training
Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer
BEHAVIORALStandard resistance training
Machine based hypertrophy training 2 x per week
BEHAVIORALDaily undulating periodization resistance training
Machine based daily undulating periodization resistance training 1 x per week
Sponsors
Friederike Rosenberger (University Hospital Heidelberg), Principal Investigator
Dietmar Hopp Stiftung
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maximal oxygen uptake (VO2peak) (endurance training groups only) | 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) | 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) | 12 weeks | Change in maximal isokinetic peak torque (MIPT) of the knee extensors assessed in a stationary dynamometer test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maximum voluntary isometric contraction (MVIC) of the knee extensors (resistance training groups only) | 12 weeks | Change in maximum voluntary isometric contraction (MVIC) of the knee extensors assessed in a stationary dynamometer test |
| Change in total work (TW) of the knee extensors | 12 weeks | Change in total work (TW) of the knee extensors assessed in a stationary dynamometer test |
| Change in muscular fatigue index (FI%) of the knee extensors | 12 weeks | Change in muscular fatigue index (FI%) of the knee extensors assessed in a stationary dynamometer test |
| Adherence to the training programs | 12 weeks | Adherence to the training programs |
| Drop-out rate in the training groups | 12 weeks | Drop-out rate in the training groups |
| Change in peak power output (PPO) (endurance training groups only) | 12 weeks | Change in peak power output (PPO) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer |
| Minor and major adverse events during training sessions | 12 weeks | Minor and major adverse events during training sessions |
| Changes in fatigue | 12 weeks | Changes in fatigue (Multidimensional Fatigue Inventory, MFI 20) |
| Changes in Quality of Life (QoL) | 12 weeks | Changes in Quality of Life (QoL) (European Research and Treatment in Cancer Quality of Life Questionnaire, EORTC QLQ-C30) |
| Changes in depression | 12 weeks | Changes in depression (Center for Epidemiologic Studies Depression Scale, CES-D) |
| Enjoyment of the training programs | 12 weeks | Enjoyment of the training programs (according to Rogers) |
| Pain during and between training sessions | 12 weeks | Pain during and between training sessions (Brief Pain Inventory, BPI) |
| Change in blood lactate threshold (endurance training groups only) | 12 weeks | Change in blood lactate threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer |
| Change in ventilatory threshold (endurance training groups only) | 12 weeks | Change in ventilatory threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer |
Countries
Germany
Outcome results
None listed