Movement and Health Beyond Care, MOVIS: Exercise and Nutrition Plan for Patients after Breast Cancer Treatment

The first chapter of the thesis provides the description of the clinical trial design (approval of the local Ethics Committee, permission number: 21/19 10 July 2019, ClinicalTrials.gov reference number: NCT04818359). Patients randomized to the intervention arm will receive lifestyle recommendations (nutrition and exercise) and will undergo the MoviS Training program, whereas control arm patients will receive lifestyle recommendations. The ‘MoviS Training’ program consists of 3 months, 3 times per week, aerobic exercise, which will be supervised both directly (2 days each week) and remotely (1 day each week). Exercise intensity (40% to 70% of heart rate reserve) and duration (20 to 60 mins) will be gradually increased throughout the training period. Both arms will receive counseling on psychological well-being. The primary outcome is the improvement of QoL. The secondary outcome is the improvement of the health-related parameters. The second chapter of the thesis evaluates the cardiometabolic effects of a home-based lifestyle intervention in the first group of MoviSBCSs, enrolled in January 2020, four weeks before the Italian COVID-19 lockdown. BCSs have been encouraged to start a 3-month lifestyle intervention based on nutrition and exercise which comprised a short term (6 months) and long term (12 and 24 months) follow-up. However, due to the imposed COVID-19 pandemic restrictions, after the approval of the institutional ethics committee, the study protocol was amended (Protocol N. 29/20 22.04.2020) and the forced changes in the study protocol made the difference between intervention arm and control arm interventions negligible, providing similar adaptations between groups. Therefore, due to the lack of significant differences between the two interventions, the results and discussion of the two groups were combined. In this section of the study it is described how a 3-month home-based lifestyle intervention, focused on Mediterranean diet and aerobic exercise - adapted to the imposed COVID-19 pandemic restrictions - significantly improved cardiorespiratory fitness, metabolic parameters, leading to significant cardiometabolic amelioration, even during two years of COVID-19 pandemic. The third chapter of the thesis describes the psychological aspects and global health-related QoL data obtained for the first group of MoviSBCSs,who received a 3-month lifestyle intervention based on nutrition and exercise during the first year of COVID-19 pandemic, as partially described in the second chapter of this thesis. Psychological questionnaires (brief fatigue inventory, distress thermometer, psychological distress inventory, verbal rating scale, European organization for research and treatment of cancer: quality-of-life, EORTC-QLQ-C30; profile of mood states questionnaire) were evaluated at baseline, immediately after the lifestyle intervention and at 3rd, 6th- and 12th months of follow-up. Analysis showed statistic