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

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.

The Refraction Assessment and the Electronic Trial Frame Measurement during Standing or Sitting Position Can Affect Postural Stability.

Vision has been shown to influence body posture. The purpose of this study is to investigate the correlations between visual acuity and body postural control both in a standing and seated position. This cohort study included 37 patients examined using Adaptica's (Italy) Kaleidos and VisionFit. Objective refraction was measured with Kaleidos both in a standing and seated position by the same operator and in the same environmental conditions. The parameters obtained with the device were binocular refraction, monocular refraction, pupil distance, pupil size, head tilt, gaze, phorias, and tropias. The results obtained were then subjectively tested using VisionFit: an electronic trial frame with phoropter functionalities. The study's outcome revealed that the differences in the visual acuity parameters obtained in standing and seated positions were statistically significant; the Student's t-test showed a p-value < 0.001 in all parameter averages. Automated refraction is widely being performed and postural control can affect the visual acuity parameters; therefore, it is relevant to consider the possibility of measuring in orthostatism. It might be appropriate to take into account the possibility of measuring in orthostatism and wearing trial frames in orthostatic conditions as well as walking freely around the room, looking outside of a window, sitting, and reading.