Movement and Health Beyond Care (MoviS)

MoviS is a randomized controlled trial on the effect of aerobic exercise training on quality of life (QoL) among breast cancer (BC) survivors. 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. Study variables will be sampled and compared between and within groups at the baseline, after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).

Sex

All

Minimum age

30 Years

Maximum age

70 Years

Inclusion criteria:

1. Diagnosis of BC (stage 0-II-III, without metastases or recurrences diagnosis at recruitment).
2. After surgery and chemotherapy and/or radiotherapy treatments.
3. Maximum 12 months from surgical treatment.
4. Minimum 6 months from the end of chemotherapy.
5. Risk of recurrence will be identified with meeting at least 1 of the following criteria: BMI at diagnosis ≥ 25 kg/m2, testosterone ≥ 0.4 ng/mL (for women); serum insulin ≥ 25 µU/mL (170 pmol/L); metabolic syndrome (at least 3 of the following 5 factors): a. glycemia ≥ 100 mg/dL (6.05 mmol/L); b. triglycerides ≥150 mg/dL (1.69 mmol L); c. HDL-C \<50 mg/dL (1.29 mmol/L) (woman), \<40 mg/dL (1.04 mmol/L) (man); d. waist circumference ≥ 80 cm (woman), ≥ 90 cm (man); e. blood pressure ≥ 130/85 mmHg.
6. Non-physically active: subjects who were not regularly active (assessed by IPAQ) for at least 6 months.

Exclusion criteria:

1. Not suitable for non-competitive physical activity after the cardiological medical examination.
2. Disabling pneumological, cardiological, neurological, orthopedic comorbidities and mental illness that prevent the exercise performance.
3. Treatment with drugs that alter the heart rate response to exercise.
4. Treatment with antidepressant drugs.

• DERIVEDAnnibalini G, Sisti D, De Santi M, Natalucci V, Imperio M, Ferri Marini C, Lucertini F, Vallorani L, Saltarelli R, Baldelli G, Barocci S, Flori M, Catalano V, Rocchi MBL, Villarini A, Emili R, Barbieri E. Lifestyle intervention based on aerobic exercise and Mediterranean diet modulates IGF-1 and its binding proteins in breast cancer survivors. Breast Cancer Res. 2026 Mar 27;28(1):81. doi: 10.1186/s13058-026-02262-3. PMID 41896896
• DERIVEDWang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322. PMID 40932107
• DERIVEDDonati Zeppa S, Natalucci V, Agostini D, Vallorani L, Amatori S, Sisti D, Rocchi MBL, Pazienza V, Perri F, Villani A, Binda E, Panebianco C, Mencarelli G, Ciuffreda L, Ferri Marini C, Annibalini G, Lucertini F, Bartolacci A, Imperio M, Virgili E, Catalano V, Piccoli G, Stocchi V, Emili R, Barbieri E. Changes in gut microbiota composition after 12 weeks of a home-based lifestyle intervention in breast cancer survivors during the COVID-19 lockdown. Front Oncol. 2023 Sep 1;13:1225645. doi: 10.3389/fonc.2023.1225645. eCollection 2023. PMID 37727203
• DERIVEDNatalucci V, Ferri Marini C, De Santi M, Annibalini G, Lucertini F, Vallorani L, Panico AR, Sisti D, Saltarelli R, Donati Zeppa S, Agostini D, Gervasi M, Baldelli G, Grassi E, Nart A, Rossato M, Biancalana V, Piccoli G, Benelli P, Villarini A, Somaini M, Catalano V, Guarino S, Pietrelli A, Monaldi S, Sarti D, Barocci S, Flori M, Rocchi MBL, Brandi G, Stocchi V, Emili R, Barbieri E. Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors. Trials. 2023 Feb 22;24(1):134. doi: 10.1186/s13063-023-07153-y. PMID 36814313