Faculty of Health Sciences of Trairi - UFRN/FACISA, Federal University of Rio Grande do Norte, Santa Cruz, Brazil.
CEST, Physiotherapy Course, Sao Luis, Brazil.
BMJ Open. 2019 Feb 19;9(2):e022306. doi: 10.1136/bmjopen-2018-022306.
Physical exercises have been recommended to improve the overall well-being of patients with fibromyalgia, with the main objective of repairing the effects of lack of physical conditioning and of improving the symptoms, especially pain and fatigue. Although widely recommended and widely known, few studies support the use of Pilates as an effective method in improving the symptoms of the disease, comparing it with other well-founded exercise modalities. This protocol was developed to describe the design of a randomised controlled study with a blind evaluator that evaluates the effectiveness of mat Pilates, comparing it with aquatic aerobic exercises, in improving pain in women with fibromyalgia.
Sixty women aged 18-60 years with a diagnosis of fibromyalgia, with a score of between 3 and 8 points on the Visual Analogue Scale for pain, and who sign the clear and informed consent form will be recruited according to the inclusion criteria. They will be randomised into one of the two intervention groups: (1) Pilates, to perform an exercise programme based on mat Pilates; and (2) aquatic exercise, to participate in a programme of aerobic exercises in the swimming pool. The protocol will correspond to 12 weeks of treatment, with both groups performing the exercises with supervision twice a week. The primary outcome will be pain (Visual Analogue Scale for pain). The secondary outcomes are to include impact related to the disease, functional capacity, sleep quality and overall quality of life. The evaluations will be performed at three points: at baseline and after 6 weeks and 12 weeks of treatment.
This protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 2.116.314). Data collection will begin after approval by the ethics committee. There will be prior contact with the women, at which time all the information about the study and the objectives will be presented, as well as resolution no 466/2012 of the National Health Council of Brazil for the year 2012, which provides guidelines and regulatory standards for research involving human beings. Participants must sign the informed consent form before the study begins.
NCT03149198.
体育锻炼已被推荐用于改善纤维肌痛患者的整体健康状况，其主要目的是修复缺乏身体适应能力的影响，并改善症状，特别是疼痛和疲劳。尽管被广泛推荐和广泛知晓，但很少有研究支持将普拉提作为一种有效的方法来改善疾病的症状，将其与其他有充分依据的运动方式进行比较。本方案旨在描述一项随机对照研究的设计，该研究采用盲法评估员，评估垫上普拉提与水上有氧运动对改善纤维肌痛女性疼痛的有效性，将其进行比较。
根据纳入标准，将符合以下条件的 60 名年龄在 18-60 岁之间、视觉模拟量表疼痛评分为 3-8 分且签署明确知情同意书的女性纤维肌痛患者纳入研究。她们将被随机分配到以下两个干预组之一：（1）普拉提组，进行基于垫上普拉提的运动方案；（2）水上运动组，参加游泳池中的有氧运动方案。方案将对应 12 周的治疗，两组均每周监督进行两次运动。主要结局指标为疼痛（视觉模拟量表疼痛评分）。次要结局指标包括与疾病相关的影响、功能能力、睡眠质量和整体生活质量。评估将在三个时间点进行：基线、治疗 6 周后和 12 周后。
本方案已获得 FACISA/UFRN 伦理委员会的批准（编号：2.116.314）。在伦理委员会批准后，数据收集将开始。在研究开始前，将与女性进行事先联系，届时将介绍研究的所有信息和目标，以及巴西国家卫生理事会 2012 年第 466/2012 号决议，该决议为涉及人类的研究提供了指导方针和监管标准。在研究开始前，参与者必须签署知情同意书。
NCT03149198。
