Abstract
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
Highlights
The high prevalence of women that do not reach the recommended level of physical activity is worrisome
The role of physical activity in clinical practice remains undervalued despite increasing evidence supporting its protective effects and the economic burden associated with a sedentary lifestyle [1]
This paper describes the protocol for a Randomized Controlled Trial (RCT) that aims to determine the clinical and cost-effectiveness of a primary care-based exercise intervention in perimenopausa women
Summary
The high prevalence of women that do not reach the recommended level of physical activity is worrisome. A recent study in Spain [3] found that women aged from 41 to 50 years emerged as the groups with a greater likelihood of being sedentary in their leisure time. This physical inactivity-derived problem can be especially relevant during the perimenopausal period. Beyond the negative effects of physical inactivity [1], menopause increases cardiometabolic risk factors due to the significant decline in the estrogen levels [4, 5]. Regular physical activity is associated with decreased risk of CVD and type 2 diabetes in middle aged women, independently of their menopause status [7]. The role of physical activity in clinical practice remains undervalued despite increasing evidence supporting its protective effects and the economic burden associated with a sedentary lifestyle [1]
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