Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study
- Conditions
- Cancer
- Interventions
- Behavioral: Standard endurance trainingBehavioral: Standard resistance trainingBehavioral: Daily undulating periodization resistance trainingBehavioral: Polarized endurance training
- Registration Number
- NCT02883699
- Lead Sponsor
- University Hospital Heidelberg
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endurance Training Group 1 Standard endurance training Standard endurance training Resistance Training Group 1 Standard resistance training Standard resistance training Resistance Training Group 2 Daily undulating periodization resistance training Daily undulating periodization resistance training Endurance Training Group 2 Polarized endurance training Polarized endurance training
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Pain during and between training sessions 12 weeks Pain during and between training sessions (Brief Pain Inventory, BPI)
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)
Trial Locations
- Locations (1)
Heidelberg University Clinic
🇩🇪Heidelberg, Germany