Movement and Health Beyond Care (MoviS)

NCT04818359 | Unknown

• 1 other identifier: UniUrb_21/10.07.2019
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Breast Cancer Survivors

Keywords

Breast Cancer; Exercise; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life assessed by questionnaire

  Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores ranging from 0 to 100; higher scores indicate better quality of life.

  Baseline - after 3, 6, 12, 24 months

Secondary Outcomes (18)

• Fatigue

  Baseline - after 3, 6, 12, 24 months

• Anthropometry

  Baseline - after 3, 6, 12, 24 months

• Body composition

  Baseline - after 3, 6, 12, 24 months

• Cardiac function indexes

  Baseline - after 3, 6, 12, 24 months

• Heart rate variability

  Baseline - after 3 months

Other Outcomes (2)

• Diet habits

  Baseline - after 3, 6, 12, 24 months

• Physical activity level

  Baseline - after 3, 6, 12, 24 months

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Supervised exercise program: MoviS Training. Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.

Behavioral: MoviS Training

Control Arm

NO INTERVENTION

Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.

Interventions

MoviS Training BEHAVIORAL

Patients will undergo a supervised exercise program consisting of 3 months of aerobic exercise training (2 d/week of directly supervised exercise and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min).

Interventional Arm

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of BC (stage 0-II-III, without metastases or recurrences diagnosis at recruitment).
• After surgery and chemotherapy and/or radiotherapy treatments.
• Maximum 12 months from surgical treatment.
• Minimum 6 months from the end of chemotherapy.
• 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.
• Non-physically active: subjects who were not regularly active (assessed by IPAQ) for at least 6 months.

You may not qualify if:

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

Sponsors & Collaborators

• University of Urbino "Carlo Bo": lead
• Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino: collaborator
• National Cancer Institute, Milan: collaborator

Study Sites (2)

Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino

Urbino, PU, 61029, Italy

Location

University of Urbino Carlo Bo

Urbino, PU, 61029, Italy

Location

Related Publications (3)

• Wang 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 DERIVED

• Donati 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 DERIVED

• Natalucci 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to undergo either a lifestyle recommendations and supervised exercise program or only lifestyle recommendations

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 26, 2021
• Study Start: January 7, 2020
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

IT (2)