Skip to main content
OpenTrials
Completed

NCT Number: NCT02883699

Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Behavior Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University Clinic

Heidelberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard endurance training

Behavioral

Continuous vigorous training 2 x per week on a cycle ergometer

Polarized endurance training

Behavioral

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

Standard Resistance Training

Behavioral

Machine based hypertrophy training 2 x per week

Daily undulating periodization resistance training

Behavioral

Machine based daily undulating periodization resistance training 1 x per week

Primary outcomes

  1. Change in maximal oxygen uptake (VO2peak) (endurance training groups only)

    Time frame: 12 weeks

    Change in maximal oxygen uptake (VO2peak) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

  2. Change in one repetition maximum (1RM) of the knee extensors (resistance training groups only)

    Time frame: 12 weeks

    Change in one repetition maximum (1RM) of the knee extensors in a machine based 1RM test

  3. Change in maximal isokinetic peak torque (MIPT) of the knee extensors (resistance training groups only)

    Time frame: 12 weeks

    Change in maximal isokinetic peak torque (MIPT) of the knee extensors assessed in a stationary dynamometer test

Secondary outcomes

  1. Change in peak power output (PPO) (endurance training groups only)

    Time frame: 12 weeks

    Change in peak power output (PPO) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

  2. Change in blood lactate threshold (endurance training groups only)

    Time frame: 12 weeks

    Change in blood lactate threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

  3. Change in ventilatory threshold (endurance training groups only)

    Time frame: 12 weeks

    Change in ventilatory threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

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

    Time frame: 12 weeks

    Change in maximum voluntary isometric contraction (MVIC) of the knee extensors assessed in a stationary dynamometer test

  5. Change in total work (TW) of the knee extensors

    Time frame: 12 weeks

    Change in total work (TW) of the knee extensors assessed in a stationary dynamometer test

  6. Change in muscular fatigue index (FI%) of the knee extensors

    Time frame: 12 weeks

    Change in muscular fatigue index (FI%) of the knee extensors assessed in a stationary dynamometer test

  7. Adherence to the training programs

    Time frame: 12 weeks

    Adherence to the training programs

  8. Drop-out rate in the training groups

    Time frame: 12 weeks

    Drop-out rate in the training groups

  9. Pain during and between training sessions

    Time frame: 12 weeks

    Pain during and between training sessions (Brief Pain Inventory, BPI)

  10. Minor and major adverse events during training sessions

    Time frame: 12 weeks

    Minor and major adverse events during training sessions

  11. Changes in fatigue

    Time frame: 12 weeks

    Changes in fatigue (Multidimensional Fatigue Inventory, MFI 20)

  12. Changes in Quality of Life (QoL)

    Time frame: 12 weeks

    Changes in Quality of Life (QoL) (European Research and Treatment in Cancer Quality of Life Questionnaire, EORTC QLQ-C30)

  13. Changes in depression

    Time frame: 12 weeks

    Changes in depression (Center for Epidemiologic Studies Depression Scale, CES-D)

  14. Enjoyment of the training programs

    Time frame: 12 weeks

    Enjoyment of the training programs (according to Rogers)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Dietmar Hopp Stiftung
  • Friederike Rosenberger (University Hospital Heidelberg), Principal Investigator

Registry information

Acronym: TOP

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2016
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.