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© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Breast cancer (BC) is the most common invasive cancer in women, and exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial aimed to evaluate the potential health benefits of exercise and proper nutritional habits. This study aims to assess the efficacy of aerobic exercise training in improving quality of life (QoL) and health-related factors in high-risk BC.

Methods

One hundred seventy-two BC survivor women, aged 30–70 years, non-metastatic, stage 0–III, non-physically active, 6–12 months post-surgery, and post chemo- or radiotherapy, will be recruited in this study. Women will be randomly allocated to the intervention arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS training consists of 12 weeks of aerobic exercise training (2 days/week of supervised and 1 day/week of unsupervised exercise) with a progressive increase in exercise intensity (40–70% of heart rate reserve) and duration (20–60 min). Both arms will receive counseling on healthy lifestyle habits (nutrition and exercise) based on the World Cancer Research Fund International (WCRF) 2018 guidelines.

The primary outcome is the improvement of the QoL. The secondary outcomes are improvement of health-related parameters such as Mediterranean diet adherence, physical activity level, flexibility, muscular fitness, fatigue, cardiorespiratory fitness (estimated maximal oxygen uptake), echocardiographic parameters, heart rate variability (average of the standard deviations of all 5 min normal to normal intervals (ASDNN/5 min) and 24 h very low and low frequency), and metabolic, endocrine, and inflammatory serum biomarkers (glycemia, insulin resistance, progesterone, testosterone, and high-sensitivity C-reactive protein).

Discussion

This trial aims to evaluate if supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence. Findings from this project could provide knowledge improvement in the field of exercise oncology through the participation of a multidisciplinary team that will provide a coordinated program of cancer care to improve healthcare quality, improve prognosis, increase survival times and QoL, and reduce the risk of BC recurrence.

Trial registration

ClinicalTrials.gov NCT04818359. Retrospectively registered on March 26, 2021

Details

Title
Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors
Author
Natalucci, Valentina 1 ; Ferri Marini, Carlo 1 ; De Santi, Mauro 1   VIAFID ORCID Logo  ; Annibalini, Giosuè 1 ; Lucertini, Francesco 1 ; Vallorani, Luciana 1 ; Panico, Andrea Rocco 1 ; Sisti, Davide 1 ; Saltarelli, Roberta 1 ; Donati Zeppa, Sabrina 1 ; Agostini, Deborah 1 ; Gervasi, Marco 1 ; Baldelli, Giulia 1 ; Grassi, Eugenio 1 ; Nart, Alessandra 1 ; Rossato, Massimo 1 ; Biancalana, Vincenzo 1 ; Piccoli, Giovanni 1 ; Benelli, Piero 1 ; Villarini, Anna 2 ; Somaini, Matteo 3 ; Catalano, Vincenzo 4 ; Guarino, Stefania 4 ; Pietrelli, Alice 4 ; Monaldi, Silvia 4 ; Sarti, Donatella 4 ; Barocci, Simone 5 ; Flori, Marco 6 ; Rocchi, Marco Bruno Luigi 1 ; Brandi, Giorgio 1 ; Stocchi, Vilberto 7 ; Emili, Rita 8 ; Barbieri, Elena 1 

 University of Urbino Carlo Bo, Department of Biomolecular Sciences, Urbino, Italy (GRID:grid.12711.34) (ISNI:0000 0001 2369 7670) 
 University of Perugia, Department of Medicine and Surgery, Perugia, Italy (GRID:grid.9027.c) (ISNI:0000 0004 1757 3630) 
 University of Milano, School of Specialization in Nutrition Science, Milan, Italy (GRID:grid.4708.b) (ISNI:0000 0004 1757 2822) 
 Hospital Santa Maria della Misericordia di Urbino, Medical Oncology, Urbino, Italy (GRID:grid.4708.b) 
 Hospital Santa Maria della Misericordia di Urbino, Clinical Pathology, Urbino, Italy (GRID:grid.4708.b) 
 Hospital Santa Maria della Misericordia di Urbino, Cardiology, Urbino, Italy (GRID:grid.4708.b) 
 University San Raffaele, Department of Human Sciences for the Promotion of Quality of Life, Rome, Italy (GRID:grid.12711.34) 
 Hospital Santa Maria della Misericordia di Urbino, Medical Oncology, Urbino, Italy (GRID:grid.12711.34) 
Pages
134
Publication year
2023
Publication date
Dec 2023
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2778777176
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.