Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors
- Conditions
- Breast Cancer Female
- Interventions
- Other: Physical exercise
- Registration Number
- NCT04337736
- Lead Sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 57
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic training Physical exercise 12-weeks, 3-days-a week, supervised aerobic (Nordic walking or Walking) physical exercise (PhE) protocol; duration of each PhE session: 70 minutes; rate of perceived exertion (RPE): 10-11 (1st-4th week); 12-13 (5th-8th week); 13-14 (9th-12th week). Resistance training Physical exercise 12-weeks, 2.3-days-a week (total of 28 lessons), supervised resistance physical exercise (PhE) protocol; duration of each PhE session: 50 minutes.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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