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CancerTOPNCT02883699

Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

A study testing Standard endurance training, Polarized endurance training and Standard resistance training in people with Cancer, run by University Hospital Heidelberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer
What is being tested?
Standard endurance training, Polarized endurance training and Standard resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteGermany
Study dates
Sep 2016to 27 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Heidelberg University Clinic

    Heidelberg, 69120

Other trials in 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.

Read the 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.

Conditions
Cancer
Being tested
Standard endurance training, Polarized endurance training, Standard resistance training, Daily undulating periodization resistance training
Keywords
Breast cancer, Prostate cancer, Exercise prescription, High intensity interval training, Daily undulating periodization training, Aerobic training, Resistance training, Physical fitness, Exercise
Medical subject headings
Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard endurance trainingBehavioural

    Continuous vigorous training 2 x per week on a cycle ergometer

  • Polarized endurance trainingBehavioural

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

  • Standard resistance trainingBehavioural

    Machine based hypertrophy training 2 x per week

  • Daily undulating periodization resistance trainingBehavioural

    Machine based daily undulating periodization resistance training 1 x per week

Study groups in NCT02883699
Study groupRoleWhat they receive
Endurance Training Group 1Active comparatorStandard endurance training
Receives: Behavioral: Standard endurance training
Endurance Training Group 2ExperimentalPolarized endurance training
Receives: Behavioral: Polarized endurance training
Resistance Training Group 1Active comparatorStandard resistance training
Receives: Behavioral: Standard resistance training
Resistance Training Group 2ExperimentalDaily undulating periodization resistance training
Receives: Behavioral: Daily undulating periodization resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

Secondary outcomes (14)

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

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

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

    Measured: 12 weeks

  4. 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

    Measured: 12 weeks

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

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

    Measured: 12 weeks

  6. 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

    Measured: 12 weeks

  7. Adherence to the training programs

    Adherence to the training programs

    Measured: 12 weeks

  8. Drop-out rate in the training groups

    Drop-out rate in the training groups

    Measured: 12 weeks

  9. Pain during and between training sessions

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

    Measured: 12 weeks

  10. Minor and major adverse events during training sessions

    Minor and major adverse events during training sessions

    Measured: 12 weeks

  11. Changes in fatigue

    Changes in fatigue (Multidimensional Fatigue Inventory, MFI 20)

    Measured: 12 weeks

  12. 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)

    Measured: 12 weeks

  13. Changes in depression

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

    Measured: 12 weeks

  14. Enjoyment of the training programs

    Enjoyment of the training programs (according to Rogers)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJan 2020
  4. Study completion27 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02883699
Sponsor's protocol ID
TOP-S-347/2016
Acronym
TOP
Status last verified
Mar 2020
First submitted
16 Aug 2016
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Pelzer F, Leisge K, Schluter K, Schneider J, Wiskemann J, Rosenberger F. Effects of exercise mode and intensity on patient-reported outcomes in cancer survivors: a four-arm intervention trial. Support Care Cancer. 2023 May 2;31(5):315. doi: 10.1007/s00520-023-07757-9.

    PubMed 37129687

Questions about this trial

What is this clinical trial studying?

A study testing Standard endurance training, Polarized endurance training and Standard resistance training in people with Cancer, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in maximal oxygen uptake (VO2peak) (endurance training groups only) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02883699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

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