Université de Haute-Alsace, Université de Strasbourg, Université de Lorraine, LISEC UR 2310, F-68100, Mulhouse, France.
Clinique gynécologique et obstétricale, Hôpital de la Croix-Rousse, groupe hospitalier Nord, CHU de Lyon-HCL, 103, grande rue de la Croix-Rousse, 69317, Lyon cedex, France.
Trials. 2023 Nov 27;24(1):759. doi: 10.1186/s13063-023-07792-1.
Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which could affect 200 million women (The term "woman" is used for convenience. Individuals gendered as man or as nonbinary can also suffer from this disease) worldwide. One of the most common symptoms of endometriosis is pelvic chronic pain associated with fatigue. This pain can cause psychological distress and interpersonal difficulties. As for several chronic diseases, adapted physical activity could help to manage the physical and psychological symptoms. The present study will investigate the effects of a videoconference-based adapted physical activity combined with endometriosis-based education program on quality of life, pain, fatigue, and other psychological symptoms and on physical activity.
This multicentric randomized-controlled trial will propose to 200 patients with endometriosis to be part of a trial which includes a 6-month program with 45 min to more than 120 min a week of adapted physical activity and/or 12 sessions of endometriosis-based education program. Effects of the program will be compared to a control group in which patients will be placed on a waiting list. All participants will be followed up 3 and 6 months after the intervention. None of the participants will be blind to the allocated trial arm. The primary outcome measure will be quality of life. Secondary outcomes will include endometriosis-related perceived pain, fatigue, physical activity, and also self-image, stereotypes, motivational variables, perceived support, kinesiophobia, basic psychological need related to physical activity, and physical activity barriers. General linear models and multilevel models will be performed. Predictor, moderator, and mediator variables will be investigated.
This study is one of the first trials to test the effects of a combined adapted physical activity and education program for improving endometriosis symptoms and physical activity. The results will help to improve care for patients with endometriosis.
ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023.
子宫内膜异位症是一种慢性疾病，其特征是子宫内膜组织在子宫腔外生长，全球可能有 2 亿女性（为方便起见使用了“女性”一词。被性别认定为男性或非二元性别者也可能患有这种疾病）受到影响。子宫内膜异位症最常见的症状之一是与疲劳相关的盆腔慢性疼痛。这种疼痛会导致心理困扰和人际关系困难。与一些慢性疾病一样，适应性身体活动有助于控制身体和心理症状。本研究将调查基于视频会议的适应性身体活动与基于子宫内膜异位症的教育计划相结合对生活质量、疼痛、疲劳和其他心理症状以及身体活动的影响。
这项多中心随机对照试验将邀请 200 名子宫内膜异位症患者参与一项试验，该试验包括为期 6 个月的计划，每周进行 45 分钟至 120 分钟以上的适应性身体活动和/或 12 次基于子宫内膜异位症的教育课程。将比较该方案的效果与对照组，对照组的患者将被置于候补名单上。所有参与者将在干预后 3 个月和 6 个月进行随访。没有参与者对分配的试验臂不知情。主要结局测量指标将是生活质量。次要结局包括与子宫内膜异位症相关的感知疼痛、疲劳、身体活动以及自我形象、刻板印象、动机变量、感知支持、运动恐惧症、与身体活动相关的基本心理需求和身体活动障碍。将进行一般线性模型和多层次模型分析。将研究预测因素、调节因素和中介因素。
这项研究是首次测试联合适应性身体活动和教育计划改善子宫内膜异位症症状和身体活动的试验之一。研究结果将有助于改善子宫内膜异位症患者的护理。
ClinicalTrials.gov，NCT05831735。注册日期：2023 年 4 月 25 日。
