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

April 12, 2020 updated by: Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 5, 2020

First Submitted That Met QC Criteria

April 5, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCSPHE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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