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| Name | Class |
|---|---|
| Friederike Rosenberger (University Hospital Heidelberg), Principal Investigator | UNKNOWN |
| Dietmar Hopp Stiftung | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endurance Training Group 1 | Active Comparator | Standard endurance training |
|
| Endurance Training Group 2 | Experimental | Polarized endurance training |
|
| Resistance Training Group 1 | Active Comparator | Standard resistance training |
|
| Resistance Training Group 2 | Experimental | Daily undulating periodization resistance training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard endurance training | Behavioral | Continuous vigorous training 2 x per week on a cycle ergometer |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Wiskemann, Dr. | Heidelberg University Hospital, National Center for Tumor Diseases, Division of Medical Oncology, Working Group Exercise Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg University Clinic | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37129687 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |
|
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 |
| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |