| Autor: |
Géraldine Escriva-Boulley, Charles-André Philip, Sophie Warembourg, Lionel Lenotre, Patrice Flore, Patrice Faure, Thierry Michy, Vincent Letouzey, Carole Arnold, Claire Piluso, Loic Chalmel, Ramzi Kacem, Georges Fabrice Blum, Renaud Detayrac, Candice Trocmé, Isabelle Brigaud, Ulysse Herbach, Patricia Branche, Emilie Faller, Aïna Chalabaev |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Trials, Vol 24, Iss 1, Pp 1-14 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
1745-6215 |
| DOI: |
10.1186/s13063-023-07792-1 |
| Popis: |
Abstract Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023 |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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