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To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.
Principal aim:
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Secondary aims:
To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | The patients in this arm will follow an exercise program for 24 weeks (i.e., during neo-adjuvant treatment), with two sessions per week including both aerobic and resistance training. Exercise intensity will range between 65% and 100% of the maximum score in the scale of Rated Perceived Exertion (RPE). |
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| Control | Other | The patients follow their usual habits as well as a Yoga program. They will also receive educational sessions on the benefits of regular physical activity (brisk walking). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Other | Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion | Change from baseline to end of intervention (i.e., after 24 weeks) |
| muscle dynamic strength | Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair) | Change from baseline to end of intervention (i.e., after 24 weeks) |
| handgrip strength | handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg) | Change from baseline to end of intervention (i.e., after 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23]) | The QLQ-C30 is a multidimensional cancer HRQoL questionnaire that contains 30 items assessing six functional and nine symptom scales. Results from this questionnaire are transformed into scores ranging from 0 to 100 according to European Organization for Research and Treatment of Cancer (EORTC) scoring, with higher scores in the functioning scales indicating a better functional status and global HRQoL, and higher scores on the symptoms' scales indicating more symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Quirónsalud de Pozuelo (HUQP) | Recruiting | Madrid | Spain |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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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Physical exercise intervention (24 weeks)
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| Control | Other | Yoga + educational program |
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| Change from baseline to end of intervention (i.e., after 24 weeks) |
| Body composition (fat mass) | fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry | Change from baseline to end of intervention (i.e., after 24 weeks) |
| Body composition (lean body mass) | lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry | Change from baseline to end of intervention (i.e., after 24 weeks) |
| Lgcortijo@Gmail.Com | Recruiting | Madrid | Spain |
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