Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

Cancer Clinical Trial

— TOP  

Official title:

Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883699
• Other study ID #: TOP-S-347/2016
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 27, 2020

Study information

• Verified date: March 2020
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 27, 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Standard endurance training
Continuous vigorous training 2 x per week on a cycle ergometer
• 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
• Standard resistance training
Machine based hypertrophy training 2 x per week
• Daily undulating periodization resistance training
Machine based daily undulating periodization resistance training 1 x per week

Locations

Country	Name	City	State
Germany	Heidelberg University Clinic	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Dietmar Hopp Stiftung, Friederike Rosenberger (University Hospital Heidelberg), Principal Investigator

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to the training programs	Adherence to the training programs	12 weeks
Secondary	Drop-out rate in the training groups	Drop-out rate in the training groups	12 weeks
Secondary	Pain during and between training sessions	Pain during and between training sessions (Brief Pain Inventory, BPI)	12 weeks
Secondary	Minor and major adverse events during training sessions	Minor and major adverse events during training sessions	12 weeks
Secondary	Changes in fatigue	Changes in fatigue (Multidimensional Fatigue Inventory, MFI 20)	12 weeks
Secondary	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
Secondary	Changes in depression	Changes in depression (Center for Epidemiologic Studies Depression Scale, CES-D)	12 weeks
Secondary	Enjoyment of the training programs	Enjoyment of the training programs (according to Rogers)	12 weeks