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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-03-31

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.

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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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Aerobic training

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).

Group Type ACTIVE_COMPARATOR

Physical exercise

Intervention Type OTHER

Resistance training

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

Group Type ACTIVE_COMPARATOR

Physical exercise

Intervention Type OTHER

Interventions

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Physical exercise

Intervention Type OTHER

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.

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No