Status:
UNKNOWN
Effects of an Intervention With EVOO and Physical Activity in Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Universidad de Granada
Collaborating Sponsors:
Consejería de Economía, Innovación y Ciencia. Proyectos de I+D+I en el marco operativo Feder Andalucía 2014-2020
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
In addition to the different pharmacological therapies available for the treatment of Systemic Lupus Erythematosus (SLE) as well as for its numerous associated complications (cutaneous, articular, hem...
Detailed Description
SLE is one of the more representative autoimmune diseases that courses with several manifestations which are cutaneous-mucosal, joint, hematologic, neuropsychiatric and/or renal. In addition to the di...
Eligibility Criteria
Inclusion
- Patients will be eligible if they have been diagnosed with SLE for at least one year and have been seen at the Outpatient Clinic of the Systemic Autoimmune Diseases Unit of the Hospital Universitario Clínico San Cecilio of Granada (Spain), meet the revised American College of Rheumatology (ACR), SLICC or ACR/EULAR criteria of 2019 and maintain a stable SLEDAI-2K, without treatment modifications, in the previous 3 months.
- Medium (8 to 11 points) to high (12 to 14 points) level of adherence to DM as measured by the 14-point DM adherence scale of the PREDIMED study.
- Sedentary, inactive or non-performing subjects of structured PE (+5h sitting or doing less than 300min of weekly physical activity or \<60min structured exercise per week).
Exclusion
- Terminal stages of the disease
- Serum creatinine levels ≥1.5mg / dl
- Type 1 Diabetes Mellitus
- Infection, trauma or surgery six months prior to intervention
- SLICC\> 5
- Pregnant, with intention, or breastfeeding
- Diagnosis of other autoimmune / inflammatory diseases
- Participation in other PE guided programs
- Contraindication for PE: psychiatric or cognitive disorders, acute or chronic conditions (advanced lung disease, high requirements, stenosis\> 70%)
- BMI of morbid obesity (≥40)
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05261529
Start Date
November 3 2021
End Date
June 30 2023
Last Update
December 20 2022
Active Locations (1)
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1
Universidad de Granada
Granada, Granada, Spain, Spain, 18016