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The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:
Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.
Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients will be assessed and screened prior the intervention. After the physical assestment they will attend 2 days a week for the supervised, and controlled sessions of physical exercise, performed in the nature (Retiro park in Madrid). To meassure the intensity of the program, they will use the 1-10 Borg ratio of perceived exertion (RPE). |
|
| Control Group | Active Comparator | Patients will be asked to mantain an active lifestyle, performing physical activity regularly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncological physical exercise intervention | Other | An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested. Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity. Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular fitness | Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Analyze the effect of the oncologic physical exercise program in the body weight, the body mass index (BMI), percentages in body fat, abdominal fat, fat free mass, bone mass and total body water in breast cancer survivors. | 16 weeks |
| Physical functionality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soraya Casla-Barrio, PhD | Tigers Running Club | Principal Investigator |
| Helios Pareja-Galeano, PhD | Universidad Autonoma de Madrid | Study Chair |
| Mónica Castellanos, MSc | Tigers Running Club | Study Chair |
| Jaime Pérez-Vélez, BSc | Tigers Running Club | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tigers Running Club | Madrid | 28009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26641959 | Background | Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 Jan-Feb;66(1):43-73. doi: 10.3322/caac.21319. Epub 2015 Dec 7. | |
| 32606609 |
| Label | URL |
|---|---|
| Figures of cancer incidence, prevalence, mortality, survival and risk factors in Spain | View source |
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The information will be shared with the patients after the completion of every test.
This information will be shared only with the participant researchers of this study.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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control trial
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Doesn´t exist. Patients were allocated depending their preferences
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|
| Active Physical Activities intervention | Other | An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life. |
|
Know the impact of the oncologic physical exercise program in the physical functionality of the patients. |
| 16 weeks |
| Exercise adherence | Measure the level of adherence to the oncologic physical exercise program, registering the assistance to the sessions. | 16 weeks |
| Physical activity Levels | Evaluate the effect of the intervention in the physical activity levels performed by the patients. | 16 weeks |
| Fatigue levels | Evaluate the impact of the physical exercise program in the fatigue levels of the participants. | 16weeks |
| Quality of life and health | Evaluate the impact of the oncological physical exercise program in the quality of life of the patients in relation with their health. | 16 weeks |
| Anxiety and depression levels | Analyze the impact of the oncologic physical exercise program in the anxiety and depression levels of the subjects. | 16 weeks |
| Background |
| Wang H, Mao X. Evaluation of the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer. Drug Des Devel Ther. 2020 Jun 18;14:2423-2433. doi: 10.2147/DDDT.S253961. eCollection 2020. |
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| 25948538 | Background | Cardinale D, Colombo A, Bacchiani G, Tedeschi I, Meroni CA, Veglia F, Civelli M, Lamantia G, Colombo N, Curigliano G, Fiorentini C, Cipolla CM. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015 Jun 2;131(22):1981-8. doi: 10.1161/CIRCULATIONAHA.114.013777. Epub 2015 May 6. |
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| D017437 |
| Skin and Connective Tissue Diseases |