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

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

Home-based lifestyle intervention for breast cancer survivors: A surprising improvement in the quality of life during the first year of COVID-19 pandemic

“…Initially, study design (Clinical trial Identifier NCT 04818359) [ 31 ] was projected as an open randomized controlled trial with two parallel arms (with a 1:1 ratio). Patients taken care of the oncology clinic of the Department of Medical Oncology of the Urbino Hospital (PU, Italy) were pre-recruited and carefully informed about the project.…”

“…In this study, we described the short- (after 3-month) and long- (after 12-month) term effects of a multidisciplinary home-based lifestyle intervention from women with BC of the ongoing MoviS (Movement and health beyond care) trial [ 31 ] during the first year of COVID-19 pandemic.…”

A home-based lifestyle intervention program reduces the tumorigenic potential of triple-negative breast cancer cells

“…Participants in this study were 30 BC survivors women enrolled in the first recruitment of the MoviS trial (protocol: NCT04818359) 15 , 16 . The study followed the guidelines of the Helsinki Declaration for research with human volunteers (1975) and was approved by the Human Research Ethics Committee of the University of Urbino Carlo Bo (Protocol N 21 of 10 July 2019).…”

The Effectiveness of Wearable Devices in Non-Communicable Diseases to Manage Physical Activity and Nutrition: Where We Are?

“…The emerging literature contains many examples of interventions, in which physical activity and nutrition are part of the same model, some of which are applied to populations living with NCDs, and the results demonstrate that this can be a model to scale up [ 97 , 98 , 99 ]. The success and feasibility of introducing this new model of care, which complements standard care, requires the implementation of specific action plans that may differ from country to country.…”