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临床试验/NCT05831735
NCT05831735招募中不适用

Adapted Physical Activity as Complementary Treatment to Alleviate the Symptoms of Endometriosis? The CRESCENDO Program (inCRease Physical Exercise and Sport to Combat ENDOmetriosis)

Upper Alsace University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Change in Perceived pain and fatigue

研究概览

简要总结

Symptoms due to endometriosis cause psychological distress and interpersonal difficulties. However, studies on the psychological and social consequences of endometriosis are scarce, none has investigated life-partners' view of the disease and its consequences, and all adopt cross-sectional designs.

Research highlights the beneficial effects of adapted physical activity (APA), on chronic diseases. Thus, APA may have a beneficial effect on the symptoms and the psychological and social consequences of endometriosis. However, studies questioning the link between PA and endometriosis are rare. The scarcity of studies can be explained by the fact that due to the painful symptoms caused by the disease; women avoid practicing. It is worth noticing that, in the specific context of endometriosis, the barriers and facilitators to PA are not clearly identified. Otherwise, due to their cross-sectional design, it is not possible for these studies to establish a causal link between PA and endometriosis. A RCT is needed to test the effects of PA on endometriosis and its consequences.

The investigators' ambition is to fill these gaps in the existing literature and to allow a more comprehensive view of the phenomena at play in the relation between PA and endometriosis. To this end, the investigators will seek to achieve 2 objectives:

  1. to identify the perceived effects of the disease on different areas of patients' lives, specifically areas related to PA, and to examine the reasons why patients are or are not physically active using a mixed methodology. Life-partners and women who do not suffer from this disease will also be involved in this study.
  2. to investigate the effects of an APA program which includes therapeutic patient education (TPE) on 3 primary outcomes: perceived pain, QoL, and PA. A complementary aim is to determine the effect of the program on psychosocial and motivational variables, and on physiological variables.

Patients will be randomly assigned to 3 groups: (1) control, (2) APA, (3) APA + TPE. The investigators hypothesize that the program could (H1) complement current treatments for endometriosis by reducing pain, increasing QoL, increasing PA, (H2) have beneficial effects on patients' physical, psychological and social health as well as physiological factors.

详细描述

a. Objectives and research hypothesis

  1. Endometriosis and its consequences Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which affects 200 million women (The investigators use the word "women" generically. However, this study takes into account gender identity. In other words, a person with endometriosis may identify as a man, as woman or no/other gender.) worldwide. In addition to infertility, one of the most common symptoms of endometriosis is pelvic chronic pain. Evidence has suggested that these symptoms result from a local inflammatory peritoneal reaction caused by ectopic endometrial implants that undergo cyclic bleeding. This disease generates significant health care costs (e.g., 9,5 billion in France) because there is no definite cure for it and its management involves pain related treatment and/or surgery. Research showed that these treatments are only relatively effective in reducing pain.

This pain can cause psychological distress and interpersonal difficulties that are as difficult to live with as the pain itself. Compared to women who do not suffer from endometriosis, women with this disease develop a lower sense of femininity, altered body image, higher levels of stress, depression and anxiety. These factors affect their quality of life (QoL) and can have deleterious effects on the response to treatment. Interpersonal relationships are also impacted such as romantic, professional and social relationships, because the symptoms make it difficult to move and carry out daily activities. However, studies on the psychological and social consequences of endometriosis are scarce, few have investigated life-partners' view of the disease and its consequences, and all adopt cross-sectional designs. 2. The effects of physical activity on endometriosis: a question for further investigation In their recent publication, INSERM (L'Institut national de la santé et de la recherche médicale) highlights the beneficial effects of regular physical activity (PA) and adapted physical activity (APA) on chronic diseases. Research suggested that (A)PA may have a beneficial effect on the physical symptoms and the psychological and social consequences of these diseases, thus may be also in endometriosis context. However, studies questioning the link between PA and endometriosis (and its symptoms) are rare, cross-sectional, and their results are inconsistent. The scarcity of studies can be explained by the fact that due to the painful symptoms caused by the disease; women do not practice much PA spontaneously and autonomously or even avoid practicing. In addition to this difficulty, widely recognized barriers to PA (i.e., lack of time, lack of adequate and nearby infrastructure, and low self-confidence and motivation for PA) can also contribute to the low level of PA. It is worth noticing that, in the specific context of endometriosis, the barriers and facilitators to the practice of PA are not clearly identified. Otherwise, due to their cross-sectional design, it was not possible for these studies to establish a causal link between PA and endometriosis. A randomized controlled trial (RCT) is needed to test the effects of (A)PA on the symptoms of endometriosis and its consequences. 3. Summary of scientific barriers to be lifted

Based on previous research and their limits, there are three major scientific barriers to be lifted regarding the investigation of the link between (A)PA and endometriosis:

  1. There is a need to better understand the psychological and social factors associated to endometriosis. For instance, consequences of endometriosis on these factors and the impact of the disease in romantic relationships (i.e., on the patient and on her life partner2) need to be more documented. Some of these factors could be related to patient PA or could mediate or moderate the relation between endometriosis (and its symptoms) and PA.
  2. Although barriers of PA are well known, in the context of endometriosis the barriers and facilitators to the practice of PA are not clearly identified. Given the specificity of this disease which only affect women and its impact on body functioning and body perception, this topic deserves to be investigated.
  3. Otherwise, due to their scarcity and their cross-sectional design, it was not possible for previous studies to strongly establish a causal link between PA and, endometriosis and its symptoms. Conducting a RCT may help to overcome this limitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years,
  • sexually active,
  • having endometriosis confirmed by laparoscopy or MRI (or saliva test if approved by health authorities),
  • reporting moderate to significant functional difficulties and pain (between 4 and 10 / 10 points on visual analogue scale), and
  • having free access to the internet to participate in the APA and TPE sessions, and fill in the questionnaires.

排除标准

  • having a disabling disease other than endometriosis (cancer, fibromyalgia, arthritis, ...),
  • a BMI higher than 35,
  • not experiencing major difficulties related to the disease,
  • having surgery or Medically Assisted Procreation scheduled within 9 months.

结局指标

主要结局

Change in Perceived pain and fatigue

时间窗: before the start of the intervention and at the end of the intervention (6 months)

10 point scale from 0 (none) to 10 (extreme pain or fatigue), today, last week en during an endometriosis episode

Change in Perceived Quality of life; Endometriosis Health Profile 30

时间窗: before the start of the intervention and at the end of the intervention(6 months)

Likert scale questionnaire about quality of life in different life domains (1 to 7 )

Change in Physical activity (PA) ; International Physical Activity Questionnaire & International Sedentary Assessment Tool

时间窗: before the start of the intervention and at the end of the intervention(6 months)

complete the number of hour and minutes spend in Light, moderate and vigourous PA and in sedentary behaviors

次要结局

  • Change in perceived social support(before the start of the intervention and at the end of the intervention(6 months))
  • Change in stereotype(before the start of the intervention and at the end of the intervention(6 months))
  • Change in self image(before the start of the intervention and at the end of the intervention(6 months))
  • Change in motivation(before the start of the intervention and at the end of the intervention(6 months))

研究者

发起方
Upper Alsace University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geraldine Escriva-Boulley

Principal investigator

Upper Alsace University

研究点 (2)

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