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

Sponsor

ITAB - Institute for Advanced Biomedical Technologies (Other)

Overall Status

Completed

CT.gov ID

NCT04337736

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Other: Physical exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Other: Physical exercise
Active Comparator: 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.	Other: Physical exercise

Arm

Intervention/Treatment

Active Comparator: 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).

Other: Physical exercise

Active Comparator: 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.

Other: Physical exercise

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

ITAB - Institute for Advanced Biomedical Technologies

Investigators

Principal Investigator: Francesco Bianco, MD, PhD, ITAB - Institute for Advanced Biomedical Technologies
Principal Investigator: Valentina Bucciarelli, MD, PhD, ITAB - Institute for Advanced Biomedical Technologies