Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors

Trials

Study Protocol

Marco Flori¹  Simone Barocci²  Sabrina Donati Zeppa³  Mauro De Santi³  Elena Barbieri³  Francesco Lucertini³  Valentina Natalucci³  Giovanni Piccoli³  Deborah Agostini³  Vincenzo Biancalana³  Roberta Saltarelli³  Giulia Baldelli³  Alessandra Nart³  Piero Benelli³  Giorgio Brandi³  Andrea Rocco Panico³  Carlo Ferri Marini³  Giosuè Annibalini³  Luciana Vallorani³  Marco Bruno Luigi Rocchi³  Marco Gervasi³  Eugenio Grassi³  Davide Sisti³  Massimo Rossato³  Vilberto Stocchi⁴  Anna Villarini⁵  Alice Pietrelli⁶  Stefania Guarino⁶  Vincenzo Catalano⁶  Donatella Sarti⁶  Silvia Monaldi⁶  Rita Emili⁶  Matteo Somaini⁷ 

[1] Cardiology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy;Clinical Pathology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy;Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy;Department of Human Sciences for the Promotion of Quality of Life, University San Raffaele, 20132, Rome, Italy;Department of Medicine and Surgery, University of Perugia, 06129, Perugia, Italy;Medical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy;School of Specialization in Nutrition Science, University of Milano, Milan, Italy;

关键词: Breast cancer;    Physical activity;    Exercise;    Mediterranean diet;    Quality of life;    Health-related parameters;    Prevention;   

DOI  :  10.1186/s13063-023-07153-y

 received in 2022-05-27, accepted in 2023-02-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundBreast 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.MethodsOne 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).DiscussionThis 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 registrationClinicalTrials.gov NCT04818359. Retrospectively registered on March 26, 2021

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 7