Skip to main content
OpenTrials
Completed

NCT Number: NCT04337736

Effects of Physical Exercise 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Female Behavior Motor Activity

Age range

Up to 65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

ITAB - Institute for Advanced Biomedical Technologies

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Apr 8, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.