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| Name | Class |
|---|---|
| German Cancer Aid | OTHER |
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The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer. Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer. However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients. The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III). In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT). Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity | Experimental | Physical activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Behavioral | The patients will perform increasing volumes of moderate intensity endurance (e.g. walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months. Patients will then maintain this activity level for the remaining 9 months, with reduced supervision. |
| Measure | Description | Time Frame |
|---|---|---|
| Target sample size | The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Physical activity will be measured using physical activity diary, heart rate monitor (Sigma Sport PC 22.13), accelerometer (Aipermotion 440), and the German version of the International Physical Activity Questionnaire (IPAQ). | at screening and 3, 6, 9, and 12 month after baseline |
| Peak oxygen consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Halle, Prof. M.D. | Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Division of Prevention and Sports Medicine TU Munich | Munich | 80809 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38654917 | Derived | Heitkamp M, Spanier B, von Korn P, Knapp S, Gross C, Haller B, Halle M. Feasibility of a 12-Month Exercise Intervention in Postsurgical Colorectal Cancer Patients. Transl Sports Med. 2023 Jan 20;2023:4488334. doi: 10.1155/2023/4488334. eCollection 2023. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
Spiroergometry will be used to assess peak oxygen consumption (VO2peak). |
| at baseline and 12 month after baseline |
| Patient satisfaction | Patient satisfaction will be measured using questionnaire. | at 3, 6, 9, and 12 month after baseline |
| Cancer related fatigue | Fatigue will be measured using the German version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-FA13; reduced version with 13 items). | at screening and 6 and 12 month after baseline |
| Anxiety and depression | Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D). | at screening and 6 and 12 month after baseline |
| Cancer related quality of life | Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30). | at screening and 6 and 12 month after baseline |
| Quality of life in colorectal cancer | Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire in colorectal cancer (EORTC QLQ-CR29). | at screening and 6 and 12 month after baseline |
| Adverse and serious adverse events | Adverse (e.g. dizziness, high blood pressure) and serious adverse events (e.g. death, prolonged hospitalization) will be reported within 24 hours to the study physician via form. | one year |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |