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

ITAB - Institute for Advanced Biomedical Technologies

Status: Completed

Conditions: Breast Cancer Female

Treatments: Other: Physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04337736

BCSPHE001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Aerobic training

Active Comparator group

Description:

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).

Treatment:

Other: Physical exercise

Resistance training

Active Comparator group

Description:

12-weeks, 2.3-days-a week (total of 28 lessons), supervised resistance physical exercise (PhE) protocol; duration of each PhE session: 50 minutes.

Treatment:

Other: Physical exercise