Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

University Hospital Heidelberg

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Polarized endurance training; Behavioral: Standard endurance training; Behavioral: Standard resistance training; Behavioral: Daily undulating periodization resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT02883699

TOP-S-347/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 4 patient groups

Endurance Training Group 1

Active Comparator group

Description:

Standard endurance training

Treatment:

Behavioral: Standard endurance training

Endurance Training Group 2

Experimental group

Description:

Polarized endurance training

Treatment:

Behavioral: Polarized endurance training

Resistance Training Group 1

Active Comparator group

Description:

Standard resistance training

Treatment:

Behavioral: Standard resistance training

Resistance Training Group 2

Experimental group

Description:

Daily undulating periodization resistance training

Treatment:

Behavioral: Daily undulating periodization resistance training