Williams Nancy I, Mallinson Rebecca J, De Souza Mary Jane
Pennsylvania State University, Department of Kinesiology, Noll Laboratory, Women's Health and Exercise Laboratory, University Park, PA, 16802, USA.
Contemp Clin Trials Commun. 2019 Jan 18;14:100325. doi: 10.1016/j.conctc.2019.100325. eCollection 2019 Jun.
Exercising women who consume inadequate energy relative to expenditure are at risk for downstream health consequences, such as menstrual cycle disturbances and poor bone health. Collectively, these conditions are known as the Female Athlete Triad (Triad). Clinicians often prescribe hormonal contraceptives to address this issue; however, the recommended treatment is reversal of the energy deficit. This paper describes the design of the REFUEL study, a randomized controlled trial (RCT) that explored the effectiveness of a 12-month intervention of increased energy intake on the reversal of an unhealthy energetic status and menstrual dysfunction and subsequent improvements in bone health in exercising women with severe menstrual cycle disturbances.
Women between the ages of 18-35 years and participating in at least 2 h/week of purposeful exercise were recruited. Those who reported irregular or absent menstrual cycles and were determined to have an exercise-associated menstrual disturbance (EAMD) were randomized into either the treatment group (EAMD + Cal), which was instructed to increase caloric intake throughout the intervention, or a control group (EAMD Control). Women who reported eumenorrhea were eligible for the ovulatory (OV) Control group. Repeated measures of energetic and metabolic status, reproductive status, and skeletal health were obtained.
The REFUEL study is the first RCT to explore a non-pharmacological treatment approach among exercising women with the Triad. 118 women were randomized, and 55 women completed the entire study. The findings of this study have the potential to inform and alter clinical practice for exercising young women who present with this condition.
相对于能量消耗而言，摄入能量不足的运动女性面临着一系列下游健康问题的风险，如月经周期紊乱和骨骼健康不佳。这些情况统称为女性运动员三联征（三联征）。临床医生通常会开激素避孕药来解决这个问题；然而，推荐的治疗方法是纠正能量不足。本文描述了REFUEL研究的设计，这是一项随机对照试验（RCT），旨在探讨为期12个月的增加能量摄入干预措施对患有严重月经周期紊乱的运动女性逆转不健康能量状态和月经功能障碍以及随后改善骨骼健康的有效性。
招募年龄在18 - 35岁之间、每周至少进行2小时有目的运动的女性。那些报告月经周期不规律或停经且被确定患有运动相关月经紊乱（EAMD）的女性被随机分为治疗组（EAMD + Cal），该组在整个干预过程中被指导增加热量摄入，或对照组（EAMD对照）。报告月经正常的女性有资格进入排卵（OV）对照组。获取了能量和代谢状态、生殖状态以及骨骼健康的重复测量数据。
REFUEL研究是第一项在患有三联征的运动女性中探索非药物治疗方法的随机对照试验。118名女性被随机分组，55名女性完成了整个研究。这项研究的结果有可能为患有这种疾病的年轻运动女性的临床实践提供信息并改变临床实践。
