About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size > or equal to 15 mm
Disqualifiers
Not meeting all of the above.
Trial design
Parallel
Treatments tested in this trial
Exercise training
Other interventionExercise 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.
Control
Other interventionYoga + educational program
Treatment groups
Trial outcomes
Primary outcomes
Cardiorespiratory fitness
peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion
muscle dynamic strength
Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)
handgrip strength
handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)
Secondary outcomes
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.
Body composition (fat mass)
fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
Body composition (lean body mass)
lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
Sponsors and contacts
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