The CRESCENDO Program (inCRease Physical Exercise and Sport to Combat ENDOmetriosis)

NCT05831735 | Unknown

• 1 other identifier: ANR-22-CE36-0002-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Endometriosis; Quality of Life

Keywords

endometriosis,; physical activity,; education,; pain; videoconferencing

Outcome Measures

Primary Outcomes (3)

• Change in Perceived pain and fatigue

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

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

• Change in Perceived Quality of life; Endometriosis Health Profile 30

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

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

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

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

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

Secondary Outcomes (4)

• Change in self image

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

• 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 motivation

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

Study Arms (3)

Control

NO INTERVENTION

This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis

Physical activity

EXPERIMENTAL

This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis + with 1h to 3 h of adapted physical activity delivered by videoconference.

Behavioral: Physical activity

Physical activity and education

EXPERIMENTAL

This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis + with 1h to 3 h of adapted physical activity delivered by videoconference + 6 session of educational and discussion groups

Behavioral: Physical activity; Behavioral: Physical activity and education

Interventions

Physical activity BEHAVIORAL

The 6-month APA program is supervised via the videoconference platform and/or carried out independently based on a personalized written program that is updated weekly. The program is based on structured sessions alternating 3 types of PA: aerobic sessions, stretching sessions and muscle strengthening sessions (to be practiced following the teacher's oral or written instructions). The sessions last from 20 minutes to 1 hour and are of low to moderate intensity depending on the initial level of fitness. The sessions are structured, adapted and progressive. During the sessions, the exercises are adapted according to the means and materials available to the patients at home or in their immediate environment. The patients will be progressively led to practice in an autonomous way (i.e., without supervision) but following an adapted, personalized and structured program. These PA sessions can be declared afterwards to the PA teacher,(duration and the exercises actually performed).

Physical activity; Physical activity and education

Physical activity and education BEHAVIORAL

In addition to the intervention in physical activity, the people participating in this program will benefit from 6 months of educational activity (EA). The EA program includes 6 sessions scheduled according to the patients' availability in groups and by videoconference. Following their entry into the study and their allocation to the programs (1 month maximum), the patients will be invited to a first individual EA session, in order to establish an educational diagnosis (1 hour). This session will allow for an assessment of their needs and the presentation of the workshops. Then, between the second and the sixth month following randomization, patients will benefit from 5 collective EA sessions per group of 6 patients maximum (1h30 to 2h). These sessions will be about PA, nutrition, pain management. An individual session will be held at the end of the intervention and will allow for an educational assessment.

Physical activity and education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Upper Alsace University: lead
• National Research Agency, France: collaborator
• EndoFrance (independant association for endometriosis): collaborator
• Hôpital de la Croix-Rousse: collaborator
• University Hospital, Strasbourg, France: collaborator
• University Hospital, Grenoble: collaborator
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

Upper Alsace University

Mulhouse, Escriva-Boulley, 68100, France

RECRUITING

Related Publications (1)

• Escriva-Boulley G, Philip CA, Warembourg S, Lenotre L, Flore P, Faure P, Michy T, Letouzey V, Arnold C, Piluso C, Chalmel L, Kacem R, Blum GF, Detayrac R, Trocme C, Brigaud I, Herbach U, Branche P, Faller E, Chalabaev A. 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. Trials. 2023 Nov 27;24(1):759. doi: 10.1186/s13063-023-07792-1.

  PMID: 38012776 DERIVED

MeSH Terms

Conditions

Endometriosis; Motor Activity; Pain

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Géraldine Escriva, Phd

  Upper Alsace University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Géraldine Escriva

CONTACT

0664229260; geraldine.escriva-boulley@uha.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: April 26, 2023
• Study Start: May 29, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The study protocol and the inform consent form will be shared at the beginning of the study (march 2023). The report will be avalaible at the end of the study (march 2024). The document will be available for 10 years.
• Access Criteria: This information will be made avalable on open research websites (sport arxiv, psycarxiv, PCI movement...) and on request by email to the first authors or the principal investigator.

Locations

FR (1)