Supervised land- and water-based exercis intervention in women with fibromyalgia: CERT- based exercise study protocol of the al-Andalus physical activity randomised controlled trial

Inmaculada C Alvarez-Gallardo, Blanca Gavilan-Carrera, Ana Carbonell-Baeza, Victor Segura-Jimenez, Daniel Camiletti-Moiron, Milkana Borges-Cosic, Virginia Aparicio, Manuel Delgado-Fernandez
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Abstract

Background: Exercise is recommended for managing fibromyalgia; however, the scant details provided about exercise programs (EP) in the available literature make standardization, replicability, and interpretation of results difficult. The aim of the present report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the land- and water-based EP implemented in the al-Andalus Randomized Controlled Trial (RCT). Methods: Women aged 35-65 with fibromyalgia (n=180) were planned to be recruited in Southern Spain (Andalucia). The study design was composed of three groups: the usual care (control) group, the land- and the water-based supervised exercise intervention groups (n=60 for each group). Participants allocated in the exercise intervention groups undertook a 24-week supervised multicomponent (strength, aerobic and flexibility) EP (three non-consecutive sessions per week, 45-60 min/session). The rationale of the exercise program is described in detail following the CERT criteria detailing its 16 key items. Discussion: This study details the supervised EP of the al-Andalus RCT project, which may serve: 1) exercise professionals who would like to implement an evidence-based supervised EP for people with fibromyalgia in land- and water-based settings, and 2) as an example of the application of the CERT criteria.
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对患有纤维肌痛的妇女进行有监督的陆上和水上运动干预:基于CERT的安达卢西亚体育锻炼随机对照试验研究方案
背景:建议通过运动来控制纤维肌痛;然而,现有文献中有关运动计划(EP)的细节很少,因此很难实现标准化、可复制性和结果解释。本报告旨在以 CERT(运动报告模板共识)为基础,全面介绍在 al-Andalus 随机对照试验(RCT)中实施的陆基和水基运动项目的原理和细节。方法:计划在西班牙南部(安达卢西亚)招募 35-65 岁患有纤维肌痛的女性(180 人)。研究设计由三组组成:常规护理(对照)组、陆上和水上监督运动干预组(每组 60 人)。被分配到运动干预组的参与者将接受为期 24 周的多成分(力量、有氧运动和柔韧性)EP(每周三次不连续的课程,每次 45-60 分钟)指导。本研究按照 CERT 标准的 16 个关键项目详细介绍了运动计划的原理:本研究详细介绍了 al-Andalus RCT 项目的指导性 EP,可为以下人员提供服务:1)希望在陆地和水上环境中为纤维肌痛患者实施循证监督 EP 的运动专业人员;2)作为 CERT 标准应用的范例。
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