Unité de Recherche Clinique, CHD-Vendée, La Roche-sur-Yon, France.
Hopital Bel Air, Service Pharmacie, Courcoué sur Logne, France.
Trials. 2020 Sep 17;21(1):800. doi: 10.1186/s13063-020-04730-3.
Exercise has been shown to significantly improve pain and function in individuals with fibromyalgia. Research into the effectiveness of exercise is often based on standardised exercise programmes that are chosen by the investigating clinical research team. However, such programmes may not necessarily be appealing to the participating patients. Furthermore, in addition to being taught exercises, patients with chronic conditions like fibromyalgia also need to learn to manage their condition themselves and so be actively involved in their treatment. The primary aim of this study is to compare the effects of two, 6-month physical activity programs on quality of life in patients with fibromyalgia. One group followed a patient-led, fibromyalgia-orientated programme (experimental) whilst the control group followed a standard, general exercise programme.
This protocol is an open-label, two-centre, randomised, controlled superiority trial. Two treatment arms will be compared: an experimental group (patient-led, fibromyalgia-orientated exercise) and a control group (general exercise program). The control group will participate in the exercise programme currently provided in our centre, which involves general, group exercise for patients with various pathologies. The experimental group will be taught the principles of exercise specifically for fibromyalgia during a one-to-one coaching session. They will then be guided in the choice of one or several types of exercise that they enjoy. They will be instructed to perform the exercise according to the recommendations for exercise in fibromyalgia with regard to intensity, duration and frequency. The protocol will last for 6 months; participants will then be followed-up for a further 6 months. They will also be encouraged to continue exercising after the end of the protocol. Outcomes will be evaluated at baseline, 6 and 12 months. The primary outcome will be quality of life (Fibromyalgia Impact Questionnaire) and the secondary outcomes will include measures of pain (including a visual analogue scale and the neuropathic characteristics of the pain), depression (Hospital Anxiety and Depression Scale), kinesiophobia (Tampa scale of kinesiophobia) and adherence (Polar OH1 heart rate monitor).
The results of this study will show if patient-led, fibromyalgia-orientated exercise is more effective than a general exercise programme on fibromyalgia-related outcomes, including quality of life, and on adherence to continued exercise.
ClinicalTrials.gov NCT03895086 . Registration no. 2018-A02881-54. Registered on 29 March 2019.
运动已被证明能显著改善纤维肌痛患者的疼痛和功能。对运动效果的研究通常基于调查临床研究团队选择的标准化运动方案。然而，这些方案对参与的患者来说不一定有吸引力。此外，除了教授运动外，纤维肌痛等慢性病患者还需要学会自我管理病情，从而积极参与治疗。本研究的主要目的是比较两种为期 6 个月的身体活动方案对纤维肌痛患者生活质量的影响。一组遵循以患者为导向的纤维肌痛导向方案（实验组），而对照组则遵循标准的一般运动方案。
本方案为开放标签、两中心、随机、对照优效性试验。将比较两个治疗组：实验组（以患者为导向的纤维肌痛运动）和对照组（一般运动方案）。对照组将参加目前在我们中心提供的运动方案，该方案涉及各种病理患者的一般、团体运动。实验组将在一对一的辅导课程中学习专门针对纤维肌痛的运动原则。然后，他们将被引导选择一种或几种他们喜欢的运动。他们将被指导根据纤维肌痛运动的建议，在强度、持续时间和频率上进行运动。方案将持续 6 个月；参与者将在接下来的 6 个月进行随访。还将鼓励他们在方案结束后继续运动。结果将在基线、6 个月和 12 个月进行评估。主要结局为生活质量（纤维肌痛影响问卷），次要结局包括疼痛测量（包括视觉模拟量表和疼痛的神经病理性特征）、抑郁（医院焦虑和抑郁量表）、运动恐惧（坦帕运动恐惧量表）和依从性（Polar OH1 心率监测器）。
本研究结果将表明，以患者为导向的纤维肌痛导向运动是否比一般运动方案更能改善纤维肌痛相关结局，包括生活质量，以及对持续运动的依从性。
ClinicalTrials.gov NCT03895086。注册号 2018-A02881-54。于 2019 年 3 月 29 日注册。
