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

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. 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.

Conditions

• Endometriosis
• Quality of Life

Interventions

BEHAVIORAL

Physical activity

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).

BEHAVIORAL

Physical activity and education

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.

Sponsors & Collaborators

• National Research Agency, France

  collaborator OTHER

• EndoFrance (independant association for endometriosis)

  collaborator UNKNOWN

• Hôpital de la Croix-Rousse

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Upper Alsace University

  lead OTHER

Principal Investigators

• Géraldine Escriva, Phd · Upper Alsace University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-29

Primary Completion

2024-06-01

Completion

2024-12-31

Countries

• France

Study Locations