• Bmc Public Health · Jun 2015

    Randomized Controlled Trial

    Cost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial.

    • Ana Carbonell-Baeza, Alberto Soriano-Maldonado, Francisco Javier Gallo, María Puerto López del Amo, Pilar Ruiz-Cabello, Ana Andrade, Milkana Borges-Cosic, Antonio Rubén Peces-Rama, Zuzana Spacírová, Inmaculada C Álvarez-Gallardo, Leticia García-Mochón, Víctor Segura-Jiménez, Fernando Estévez-López, Daniel Camiletti-Moirón, Jose Jesús Martín-Martín, Pilar Aranda, Manuel Delgado-Fernández, and Virginia A Aparicio.
    • Department of Physical Education, Faculty of Education Science, University of Cádiz, Cádiz, Spain. ana.carbonell@uca.es.
    • Bmc Public Health. 2015 Jun 17; 15: 555.

    BackgroundThe high prevalence of women that do not reach the recommended level of physical activity is worrisome. A sedentary lifestyle has negative consequences on health status and increases health care costs. The main objective of this project is to assess the cost-effectiveness of a primary care-based exercise intervention in perimenopausal women.Methods/DesignThe present study is a Randomized Controlled Trial. A total of 150 eligible women will be recruited and randomly assigned to either a 16-week exercise intervention (3 sessions/week), or to usual care (control) group. The primary outcome measure is the incremental cost-effectiveness ratio. The secondary outcome measures are: i) socio-demographic and clinical information; ii) body composition; iii) dietary patterns; iv) glycaemic and lipid profile; v) physical fitness; vi) physical activity and sedentary behaviour; vii) sleep quality; viii) quality of life, mental health and positive health; ix) menopause symptoms. All outcomes will be assessed at baseline and post intervention. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct a cost effectiveness analysis from a health system perspective.DiscussionThe intervention designed is feasible and if it proves to be clinically and cost effective, it can be easily transferred to other similar contexts. Consequently, the findings of this project might help the Health Systems to identify strategies for primary prevention and health promotion as well as to reduce health care requirements and costs.Trial RegistrationClinicalTrials.gov Identifier: NCT02358109. Date of registration: 05/02/2015.

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