Clinical trial NCT02883699: Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study
Official title: Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Breast cancer
Prostate cancer
Exercise prescription
High intensity interval training
Daily undulating periodization training
Aerobic training
Resistance training
Physical fitness
Exercise
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Friederike Rosenberger (University Hospital Heidelberg), Principal Investigator
name: Dietmar Hopp Stiftung
First posted: 2016-08-30
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in maximal oxygen uptake (VO2peak) (endurance training groups only)
timeFrame: 12 weeks
measure: Change in one repetition maximum (1RM) of the knee extensors (resistance training groups only)
timeFrame: 12 weeks
measure: Change in maximal isokinetic peak torque (MIPT) of the knee extensors (resistance training groups only)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in peak power output (PPO) (endurance training groups only)
timeFrame: 12 weeks
measure: Change in blood lactate threshold (endurance training groups only)
timeFrame: 12 weeks
measure: Change in ventilatory threshold (endurance training groups only)
timeFrame: 12 weeks
measure: Change in maximum voluntary isometric contraction (MVIC) of the knee extensors (resistance training groups only)
timeFrame: 12 weeks
measure: Change in total work (TW) of the knee extensors
timeFrame: 12 weeks
measure: Change in muscular fatigue index (FI%) of the knee extensors
timeFrame: 12 weeks
measure: Adherence to the training programs
timeFrame: 12 weeks
measure: Drop-out rate in the training groups
timeFrame: 12 weeks
measure: Pain during and between training sessions
timeFrame: 12 weeks
measure: Minor and major adverse events during training sessions
timeFrame: 12 weeks
measure: Changes in fatigue
timeFrame: 12 weeks
measure: Changes in Quality of Life (QoL)
timeFrame: 12 weeks
measure: Changes in depression
timeFrame: 12 weeks
measure: Enjoyment of the training programs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Clinic
Study officials:
affiliation: Heidelberg University Hospital, National Center for Tumor Diseases, Division of Medical Oncology, Working Group Exercise Oncology
name: Joachim Wiskemann, Dr.
role: PRINCIPAL_INVESTIGATOR
References: