Physical Exercise
Conditions
Keywords
exercise, high interval training, resistance exercise
Brief summary
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).
Detailed description
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.
Interventions
OTHERExercise training
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.
OTHERControl
Yoga + educational program
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Physical exercise intervention (24 weeks)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Not meeting all of the above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory fitness | Change from baseline to end of intervention (i.e., after 24 weeks) | peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion |
| muscle dynamic strength | Change from baseline to end of intervention (i.e., after 24 weeks) | Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair) |
| handgrip strength | Change from baseline to end of intervention (i.e., after 24 weeks) | handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23]) | Change from baseline to end of intervention (i.e., after 24 weeks) | 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) | Change from baseline to end of intervention (i.e., after 24 weeks) | fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry |
| Body composition (lean body mass) | Change from baseline to end of intervention (i.e., after 24 weeks) | lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry |
Countries
Spain
Outcome results
None listed