Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors
Authors: Natalucci Valentina , Ferri Marini Carlo , De Santi Mauro , Annibalini Giosuè , Lucertini Francesco , Vallorani Luciana , Panico Andrea Rocco , Sisti Davide , Saltarelli Roberta , Donati Zeppa Sabrina , Agostini Deborah , Gervasi Marco , Baldelli Giulia , Grassi Eugenio , Nart Alessandra , Rossato Massimo , Biancalana Vincenzo , Piccoli Giovanni , Benelli Piero , Villarini Anna , Somaini Matteo , Catalano Vincenzo , Guarino Stefania , Pietrelli Alice , Monaldi Silvia , Sarti Donatella , Barocci Simone , Flori Marco , Rocchi Marco Bruno Luigi , Brandi Giorgio , Stocchi Vilberto , Emili Rita , Barbieri Elena 
Published: February 2023

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