Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Different Physical Exercise Protocols on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Other: Physical exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic training<br>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). | Other: Physical exercise<br> <br> |
| Active Comparator: Resistance training<br>12-weeks, 2.3-days-a week (total of 28 lessons), supervised resistance physical exercise (PhE) protocol; duration of each PhE session: 50 minutes. | Other: Physical exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of cardio-vascular efficiency | 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 | 12-weeks (from the beginning of physical exercise training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epicardial fat thickness reduction | A reduction in epicardial fat thickness evaluated with echocardiographic method | 12-weeks (from the beginning of physical exercise training) | 
| Intima-media thickness reduction | A reduction in epicardial fat thickness evaluated with ultrasonographic method | 12-weeks (from the beginning of physical exercise training) | 
| Improvement of quality of life | 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) | 12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment | 
| Improvement of spontaneous physical activity | 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) | a mean of 34 months from the enrollment | 
| Improvement of cardiovascular quality of life | 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 | a mean of 34 months from the enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical exercise, Adherence to physical exercise, Global longitudinal strain, Ventricular-arterial coupling, Arterial stiffness, Epicardial fat thickness, Intima-media thickness, Endocrine therapy