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Clinical Trials/NCT04337736
NCT04337736
Completed
Not Applicable

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

ITAB - Institute for Advanced Biomedical Technologies0 sites57 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
ITAB - Institute for Advanced Biomedical Technologies
Enrollment
57
Primary Endpoint
Improvement of cardio-vascular efficiency
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
March 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
ITAB - Institute for Advanced Biomedical Technologies
Responsible Party
Principal Investigator
Principal Investigator

Francesco Bianco

Researcher

ITAB - Institute for Advanced Biomedical Technologies

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Epicardial fat thickness reduction(12-weeks (from the beginning of physical exercise training))
  • Intima-media thickness reduction(12-weeks (from the beginning of physical exercise training))
  • Improvement of 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(a mean of 34 months from the enrollment)
  • Improvement of cardiovascular quality of life(a mean of 34 months from the enrollment)

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