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Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10680283/ https://www.ncbi.nlm.nih.gov/pubmed/38012776 http://dx.doi.org/10.1186/s13063-023-07792-1 |
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author | Escriva-Boulley, Géraldine Philip, Charles-André Warembourg, Sophie Lenotre, Lionel Flore, Patrice Faure, Patrice Michy, Thierry Letouzey, Vincent Arnold, Carole Piluso, Claire Chalmel, Loic Kacem, Ramzi Blum, Georges Fabrice Detayrac, Renaud Trocmé, Candice Brigaud, Isabelle Herbach, Ulysse Branche, Patricia Faller, Emilie Chalabaev, Aïna |
author_facet | Escriva-Boulley, Géraldine Philip, Charles-André Warembourg, Sophie Lenotre, Lionel Flore, Patrice Faure, Patrice Michy, Thierry Letouzey, Vincent Arnold, Carole Piluso, Claire Chalmel, Loic Kacem, Ramzi Blum, Georges Fabrice Detayrac, Renaud Trocmé, Candice Brigaud, Isabelle Herbach, Ulysse Branche, Patricia Faller, Emilie Chalabaev, Aïna |
author_sort | Escriva-Boulley, Géraldine |
collection | PubMed |
description | 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07792-1. |
format | Online Article Text |
id | pubmed-10680283 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-106802832023-11-27 Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study Escriva-Boulley, Géraldine Philip, Charles-André Warembourg, Sophie Lenotre, Lionel Flore, Patrice Faure, Patrice Michy, Thierry Letouzey, Vincent Arnold, Carole Piluso, Claire Chalmel, Loic Kacem, Ramzi Blum, Georges Fabrice Detayrac, Renaud Trocmé, Candice Brigaud, Isabelle Herbach, Ulysse Branche, Patricia Faller, Emilie Chalabaev, Aïna Trials Study Protocol 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07792-1. BioMed Central 2023-11-27 /pmc/articles/PMC10680283/ /pubmed/38012776 http://dx.doi.org/10.1186/s13063-023-07792-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Escriva-Boulley, Géraldine Philip, Charles-André Warembourg, Sophie Lenotre, Lionel Flore, Patrice Faure, Patrice Michy, Thierry Letouzey, Vincent Arnold, Carole Piluso, Claire Chalmel, Loic Kacem, Ramzi Blum, Georges Fabrice Detayrac, Renaud Trocmé, Candice Brigaud, Isabelle Herbach, Ulysse Branche, Patricia Faller, Emilie Chalabaev, Aïna Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study |
title | Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study |
title_full | Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study |
title_fullStr | Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study |
title_full_unstemmed | Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study |
title_short | Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study |
title_sort | effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the crescendo program (increase physical exercise and sport to combat endometriosis) protocol study |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10680283/ https://www.ncbi.nlm.nih.gov/pubmed/38012776 http://dx.doi.org/10.1186/s13063-023-07792-1 |
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