Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

Study Overview
=================
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.

Official Title
-----------------
Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Standard endurance training
* Behavioral: Polarized endurance training
* Behavioral: Standard resistance training
* Behavioral: Daily undulating periodization resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endurance Training Group 1<br>Standard endurance training | Behavioral: Standard endurance training<br>* Continuous vigorous training 2 x per week on a cycle ergometer<br>|
| Experimental: Endurance Training Group 2<br>Polarized endurance training | Behavioral: Polarized endurance training<br>* Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer<br>|
| Active Comparator: Resistance Training Group 1<br>Standard resistance training | Behavioral: Standard resistance training<br>* Machine based hypertrophy training 2 x per week<br>|
| Experimental: Resistance Training Group 2<br>Daily undulating periodization resistance training | Behavioral: Daily undulating periodization resistance training<br>* Machine based daily undulating periodization resistance training 1 x per week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal oxygen uptake (VO2peak) (endurance training groups only) | Change in maximal oxygen uptake (VO2peak) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer | 12 weeks | 
| Change in one repetition maximum (1RM) of the knee extensors (resistance training groups only) | Change in one repetition maximum (1RM) of the knee extensors in a machine based 1RM test | 12 weeks | 
| Change in maximal isokinetic peak torque (MIPT) of the knee extensors (resistance training groups only) | Change in maximal isokinetic peak torque (MIPT) of the knee extensors assessed in a stationary dynamometer test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak power output (PPO) (endurance training groups only) | Change in peak power output (PPO) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer | 12 weeks | 
| Change in blood lactate threshold (endurance training groups only) | Change in blood lactate threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer | 12 weeks | 
| Change in ventilatory threshold (endurance training groups only) | Change in ventilatory threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer | 12 weeks | 
| Change in maximum voluntary isometric contraction (MVIC) of the knee extensors (resistance training groups only) | Change in maximum voluntary isometric contraction (MVIC) of the knee extensors assessed in a stationary dynamometer test | 12 weeks | 
| Change in total work (TW) of the knee extensors | Change in total work (TW) of the knee extensors assessed in a stationary dynamometer test | 12 weeks | 
| Change in muscular fatigue index (FI%) of the knee extensors | Change in muscular fatigue index (FI%) of the knee extensors assessed in a stationary dynamometer test | 12 weeks | 
| Adherence to the training programs | Adherence to the training programs | 12 weeks | 
| Drop-out rate in the training groups | Drop-out rate in the training groups | 12 weeks | 
| Pain during and between training sessions | Pain during and between training sessions (Brief Pain Inventory, BPI) | 12 weeks | 
| Minor and major adverse events during training sessions | Minor and major adverse events during training sessions | 12 weeks | 
| Changes in fatigue | Changes in fatigue (Multidimensional Fatigue Inventory, MFI 20) | 12 weeks | 
| Changes in Quality of Life (QoL) | Changes in Quality of Life (QoL) (European Research and Treatment in Cancer Quality of Life Questionnaire, EORTC QLQ-C30) | 12 weeks | 
| Changes in depression | Changes in depression (Center for Epidemiologic Studies Depression Scale, CES-D) | 12 weeks | 
| Enjoyment of the training programs | Enjoyment of the training programs (according to Rogers) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Prostate cancer, Exercise prescription, High intensity interval training, Daily undulating periodization training, Aerobic training, Resistance training, Physical fitness, Exercise