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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program.
All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized.
All patients are to receive identical counseling for ideal nutritional, life-style and physical activity.
Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling | Other | Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. |
|
| Controlled physical activity | Experimental | All patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | Nutritional, lifestyle and sports counseling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity. | after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis | after 6 and 12 months | |
| Evaluation of the influence of controlled/observed physical activity versus lifestyle counseling only on Fitness level, Quality of Life, rate of infections, weight, body mass index BMI, Body fat percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Greil, Prof.Dr. | Arbeitsgemeinschaft medikamentoese Tumortherapie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum | Salzburg | 5020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30415507 | Derived | Westphal T, Rinnerthaler G, Gampenrieder SP, Niebauer J, Thaler J, Pfob M, Fuchs D, Riedmann M, Mayr B, Reich B, Melchardt T, Mlineritsch B, Pleyer L, Greil R. Supervised versus autonomous exercise training in breast cancer patients: A multicenter randomized clinical trial. Cancer Med. 2018 Dec;7(12):5962-5972. doi: 10.1002/cam4.1851. Epub 2018 Nov 10. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| physical activity |
| Behavioral |
counseling and controlled physical activity |
|
| after 6 and 12 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005159 | Health Care Facilities Workforce and Services |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |