Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

University Hospital Heidelberg132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

132

Conditions

Cancer

Interventions

Standard endurance trainingBEHAVIORAL

Continuous vigorous training 2 x per week on a cycle ergometer

Polarized endurance trainingBEHAVIORAL

Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer

Standard resistance trainingBEHAVIORAL

Machine based hypertrophy training 2 x per week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Heidelberg University Clinic

Heidelberg, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Change in maximum voluntary isometric contraction (MVIC) of the knee extensors (resistance training groups only)

Data from ClinicalTrials.gov

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