Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study (TOP)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Standard endurance training; Behavioral: Polarized endurance training; Behavioral: Standard resistance training; Behavioral: Daily undulating periodization resistance training

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Heidelberg University Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: Dietmar Hopp Stiftung; Friederike Rosenberger (University Hospital Heidelberg), Principal Investigator
• Investigators: Principal Investigator: Joachim Wiskemann, Dr., Heidelberg University Hospital, National Center for Tumor Diseases, Division of Medical Oncology, Working Group Exercise Oncology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Breast cancer; Prostate cancer; Physical fitness; Aerobic training; High intensity interval training; Resistance training; Exercise prescription; Daily undulating periodization training
• Other Study ID Numbers: TOP-S-347/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO