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 nut...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07153-y |
| _version_ | 1827982861488095232 |
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| author | Valentina Natalucci Carlo Ferri Marini Mauro De Santi Giosuè Annibalini Francesco Lucertini Luciana Vallorani Andrea Rocco Panico Davide Sisti Roberta Saltarelli Sabrina Donati Zeppa Deborah Agostini Marco Gervasi Giulia Baldelli Eugenio Grassi Alessandra Nart Massimo Rossato Vincenzo Biancalana Giovanni Piccoli Piero Benelli Anna Villarini Matteo Somaini Vincenzo Catalano Stefania Guarino Alice Pietrelli Silvia Monaldi Donatella Sarti Simone Barocci Marco Flori Marco Bruno Luigi Rocchi Giorgio Brandi Vilberto Stocchi Rita Emili Elena Barbieri |
| author_facet | Valentina Natalucci Carlo Ferri Marini Mauro De Santi Giosuè Annibalini Francesco Lucertini Luciana Vallorani Andrea Rocco Panico Davide Sisti Roberta Saltarelli Sabrina Donati Zeppa Deborah Agostini Marco Gervasi Giulia Baldelli Eugenio Grassi Alessandra Nart Massimo Rossato Vincenzo Biancalana Giovanni Piccoli Piero Benelli Anna Villarini Matteo Somaini Vincenzo Catalano Stefania Guarino Alice Pietrelli Silvia Monaldi Donatella Sarti Simone Barocci Marco Flori Marco Bruno Luigi Rocchi Giorgio Brandi Vilberto Stocchi Rita Emili Elena Barbieri |
| author_sort | Valentina Natalucci |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-09T22:39:45Z |
| format | Article |
| id | doaj.art-cde48d2bca484bf98e1932104b389356 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:45Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-cde48d2bca484bf98e1932104b3893562023-03-22T12:17:39ZengBMCTrials1745-62152023-02-0124111510.1186/s13063-023-07153-yMovement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivorsValentina Natalucci0Carlo Ferri Marini1Mauro De Santi2Giosuè Annibalini3Francesco Lucertini4Luciana Vallorani5Andrea Rocco Panico6Davide Sisti7Roberta Saltarelli8Sabrina Donati Zeppa9Deborah Agostini10Marco Gervasi11Giulia Baldelli12Eugenio Grassi13Alessandra Nart14Massimo Rossato15Vincenzo Biancalana16Giovanni Piccoli17Piero Benelli18Anna Villarini19Matteo Somaini20Vincenzo Catalano21Stefania Guarino22Alice Pietrelli23Silvia Monaldi24Donatella Sarti25Simone Barocci26Marco Flori27Marco Bruno Luigi Rocchi28Giorgio Brandi29Vilberto Stocchi30Rita Emili31Elena Barbieri32Department of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Medicine and Surgery, University of PerugiaSchool of Specialization in Nutrition Science, University of MilanoMedical Oncology, Hospital Santa Maria della Misericordia di UrbinoMedical Oncology, Hospital Santa Maria della Misericordia di UrbinoMedical Oncology, Hospital Santa Maria della Misericordia di UrbinoMedical Oncology, Hospital Santa Maria della Misericordia di UrbinoMedical Oncology, Hospital Santa Maria della Misericordia di UrbinoClinical Pathology, Hospital Santa Maria della Misericordia di UrbinoCardiology, Hospital Santa Maria della Misericordia di UrbinoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Biomolecular Sciences, University of Urbino Carlo BoDepartment of Human Sciences for the Promotion of Quality of Life, University San RaffaeleMedical Oncology, Hospital Santa Maria della Misericordia di UrbinoDepartment of Biomolecular Sciences, University of Urbino Carlo BoAbstract 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, 2021https://doi.org/10.1186/s13063-023-07153-yBreast cancerPhysical activityExerciseMediterranean dietQuality of lifeHealth-related parameters |
| spellingShingle | Valentina Natalucci Carlo Ferri Marini Mauro De Santi Giosuè Annibalini Francesco Lucertini Luciana Vallorani Andrea Rocco Panico Davide Sisti Roberta Saltarelli Sabrina Donati Zeppa Deborah Agostini Marco Gervasi Giulia Baldelli Eugenio Grassi Alessandra Nart Massimo Rossato Vincenzo Biancalana Giovanni Piccoli Piero Benelli Anna Villarini Matteo Somaini Vincenzo Catalano Stefania Guarino Alice Pietrelli Silvia Monaldi Donatella Sarti Simone Barocci Marco Flori Marco Bruno Luigi Rocchi Giorgio Brandi Vilberto Stocchi Rita Emili Elena Barbieri Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors Trials Breast cancer Physical activity Exercise Mediterranean diet Quality of life Health-related parameters |
| title | Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors |
| title_full | Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors |
| title_fullStr | Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors |
| title_full_unstemmed | Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors |
| title_short | Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors |
| title_sort | movement and health beyond care movis study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors |
| topic | Breast cancer Physical activity Exercise Mediterranean diet Quality of life Health-related parameters |
| url | https://doi.org/10.1186/s13063-023-07153-y |
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