An interventional study of Exercise training and Control in Physical Exercise, sponsored by Universidad Europea de Madrid. Recruiting at 2 sites in Spain. Open to female participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by Universidad Europea de Madrid · Not applicable, Interventional, and Other
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.
Universidad Europea de Madrid is the lead sponsor of 94 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: Exercise training
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).
Other: Control
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.
Yoga + educational program
Cardiorespiratory fitness
peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
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.
Time frame: 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
Time frame: 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
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Europea de Madrid