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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Upper Alsace University
RECRUITING
Mulhouse
Contact Information
Primary
Géraldine Escriva
geraldine.escriva-boulley@uha.fr
0664229260
Time Frame
Start Date: 2023-05-29
Estimated Completion Date: 2024-12
Participants
Target number of participants: 200
Treatments
No_intervention: Control
This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis
Experimental: Physical activity
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.
Experimental: Physical activity and education
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
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Strasbourg, France, National Research Agency, France, Centre Hospitalier Universitaire de Nīmes, Hôpital de la Croix-Rousse, University Hospital, Grenoble, EndoFrance (independant association for endometriosis)
Leads: Upper Alsace University

This content was sourced from clinicaltrials.gov