Breast Cancer Female
Conditions
Keywords
Physical exercise, Adherence to physical exercise, Global longitudinal strain, Ventricular-arterial coupling, Arterial stiffness, Epicardial fat thickness, Intima-media thickness, Endocrine therapy
Brief summary
To examine the effects of different physical exercise protocols (aerobic training and resistance training) on cardio-vascular efficiency and quality of life in a population of breast cancer survivors (BCS), not treated with chemotherapy.
Detailed description
The present study enrolled a population of BCS women who underwent surgical treatment for breast cancer at the Ospedale G. Bernabeo of Ortona, Chieti, Italy. The participants were randomized to the following physical exercise protocols: aerobic training, walking or Nordic walking; resistance training. All the participants have been examined utilizing transthoracic echocardiography, carotid ultrasound and photo-plethysmographic method for the analysis of arterial stiffness, before and after the physical exercise protocol (T0-T1). The two-dimensional speckle-tracking analysis was performed with an offline, dedicated software from the apical 4-chambers-view. Moreover, ventricular-arterial coupling, epicardial fat thickness and intima-media thickness were also analyzed. Quality of life was assessed using SF-36 score at T0, T1 and at a mean follow-up of 34 months. Moreover, at follow-up, we evaluated spontaneous physical activity and cardiovascular quality of life using IPAQ and SAQ-7 scores.
Interventions
OTHERPhysical exercise
Sponsors
ITAB - Institute for Advanced Biomedical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* age \< 65 years; * history of breast cancer surgery in the previous 12 months; * no history of chemotherapy; * no ongoing radiotherapy; * eventual hormonal therapy; * cardiovascular and orthopedic eligibility.
Exclusion criteria
* adjuvant chemotherapy; * any history of cardiovascular disease; * abnormal exercise stress test at the screening; * any systemic inflammatory disease or any orthopedic condition potentially limiting the physical training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of cardio-vascular efficiency | 12-weeks (from the beginning of physical exercise training) | A composite of the improvement in the following parameters, from pre-treatment values: global longitudinal strain analysis, as assessed by speckle-traking echocardiography; ventricular-arterial coupling, as assessed by echocardiographic single beat method; arterial stiffness (pulse wave velocity, augmentation index), as assessed by photoplethysmographic method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epicardial fat thickness reduction | 12-weeks (from the beginning of physical exercise training) | A reduction in epicardial fat thickness evaluated with echocardiographic method |
| Intima-media thickness reduction | 12-weeks (from the beginning of physical exercise training) | A reduction in epicardial fat thickness evaluated with ultrasonographic method |
| Improvement of quality of life | 12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment | An improvement of quality of life, from pre-treatment values, evaluated with the 36-Item Short Form Health Survey (minimum value: 0, associated with the worst quality of life; maximum value: 100, associated with the best quality of life) |
| Improvement of spontaneous physical activity | a mean of 34 months from the enrollment | An improvement of spontaneous physical activity evaluated with International Physical Activity Questionnaire score (0-700 MET: low level of physical activity; 700-2519 MET: intermediate level of physical activity; \> 2520 MET: high level of physical activity) |
| Improvement of cardiovascular quality of life | a mean of 34 months from the enrollment | An improvement of quality of life evaluated with the Seattle Angina Questionnaire-7 score (minimum value: 0, associated with more symptoms and with the worst quality of life; maximum value: 100, associated with fewer symptoms and with the best quality of life) where higher scores indicate fewer symptoms and higher health-related quality of life |
Outcome results
None listed