- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06776627
Effectiveness of an Adapted Physical Activity Program on Improving the Health-related Quality of Life of Women With Endometriosis in Martinique (APAENDO)
There is no specific treatment for endometriosis, because the pathophysiology is poorly understood.
Adapted physical activity (APA) is recognized as a beneficial supportive care for patients suffering from chronic pathology. Adapted physical activity can play a role in managing endometriosis symptoms. Studies have shown that regular physical exercise can help reduce pain, improve quality of life and alleviate symptoms related to chronic diseases.
However, it is known that few women with endometriosis have regular physical activity because of pain, chronic fatigue that lead to activity limitation or even disability.
This study provides an opportunity to evaluate the impact of regular APA practice on improving the quality of life and symptoms of women with endometriosis in Martinique.
Based on this, APA could be included in the endometriosis care pathway in Martinique.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Martinique
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Fort-de-France, Martinique, France, 97261
- University Hospital Center of Martinique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult woman of childbearing age,
- Clinico-radiological or clinico-histological diagnosis of endometriosis: laparoscopy with biopsy or MRI,
- History of endometriosis symptoms before diagnosis,
- Walking without technical assistance,
- Able to read and write,
- Patient wishing to improve her health by optimizing her lifestyle,
- Patient affiliated or beneficiary of a social security scheme,
- Patient having given free, informed and written consent.
Exclusion Criteria:
- Acute or terminal illness,
- Recent fracture of the upper or lower limbs (< 3 months),
- Other chronic unstable or orthopedic illness that could interfere with the ability to participate in a physical activity program,
- Resting ECG at inclusion outside the normal range,
- Patients who practice moderate to intense physical activity for more than 150 minutes per week,
- Absolute contraindication to physical activity linked to severe co-morbidities,
- Patient placed under legal protection, guardianship or curatorship,
- Pregnant or breastfeeding woman.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Routine care
31 patients: Routine consultation including:
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Experimental: Routine care + adapted physical activity (APA)
Patients randomized to the APA group will be prescribed, at the end of the routine consultation, 12 weeks of adapted physical activity sessions, to be carried out outdoors, and coordinated by a qualified professional from the STAPS sector (Master's degree in Science and Technology of Physical and Sporting Activities).
The latter will provide patients with an adapted program determined following a personalized physical condition assessment: aerobic capacity, strength, endurance, flexibility, balance and proprioception tests.
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Adapted program: aerobic capacity, strength, endurance, flexibility, balance and proprioception tests.
APA sessions take place over 12 weeks.
There will be 2 to 3 sessions per week.
Course of a session: - Warm-up: 10-15min: cycling or walking.
- Moderate-intensity endurance activity: cycling, walking or swimming: 10min, the duration will be increased gradually up to a minimum of 30min at the end of the program.
- Muscle strengthening: with polyarticular or monoarticular exercises targeting the upper limbs or lower limbs in alternation and sheathing.
At the beginning: 8 exercises per session and 8 repetitions, 1 time per week.
Objective will be to increase the number of repetitions and then integrate other exercises to reach 10 exercises with 12 repetitions, 2 times per week.
- Stretching and balance: learning to stretch the muscle groups worked and then working on proprioception (bipodal, monopodal station, then double task).
- Quiet time: relaxation through breathing 5 min.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the effectiveness at 12 weeks of an adapted physical activity program on the health-related quality of life of patients with endometriosis.
Time Frame: 12 weeks
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The level of health-related quality of life will be measured using the EHP-30 (Endometriosis Health Profile) questionnaire. The minimum value is 0, and the maximum value is 100. Higher score mean a worse outcome. |
12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the effectiveness at 9 weeks of an adapted physical activity program in patients with endometriosis on health-related quality of life.
Time Frame: 12 weeks
|
The level of health-related quality of life will be measured using the EHP-30 (Endometriosis Health Profile) questionnaire.
The minimum value is 0, and the maximum value is 100.
Higher score mean a worse outcome.
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12 weeks
|
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of pain
Time Frame: 12 weeks
|
Pain will be assessed by the Visual Analogue Scale.
The minimum value is 0 cm, and the maximum value is 10 cm.
Higher score mean a worse outcome.
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12 weeks
|
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of functional capacities of physical condition, and activity level
Time Frame: 12 weeks
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Assessed by the Ricci and Gagnon questionnaire.
The minimum value is 9, and the maximum value is 45.
Higher score mean a better outcome.
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12 weeks
|
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improving sleep quality
Time Frame: 12 weeks
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Sleep quality with the questionnaire: PSQI (Pittsburgh Sleep Quality Index).
The minimum value is 0, and the maximum value is 21.
Higher score mean a worse outcome.
|
12 weeks
|
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improving the professional, psychosocial impact of the disease in the daily lives of patients
Time Frame: 12 weeks
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The psycho-socio-family and professional impact by using the part 2 of the EHP-30 (Endometriosis Health Profile) (section A and B).
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12 weeks
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
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Functional capacities of physical condition: measurement of blood pressure.
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12 weeks
|
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
|
Functional capacities of physical condition: measurement of heart rate.
|
12 weeks
|
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To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
|
Functional capacities of physical condition: grip muscle strength (hand grip).
|
12 weeks
|
|
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
|
Functional capacities of physical condition: measurement of flexibility: with finger/ground distance.
|
12 weeks
|
|
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
|
Functional capacities of physical condition: measurement of walking capacity with the 6-minute walk test.
|
12 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24_RIPH2-03
- 2024-A01875-42 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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