Systemic Lupus Erythematosus
Conditions
Interventions
Experimental group:Progressive Exercise Intervention
Control group:None
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1, Confirmation of diagnosis and disease activity score: Compliance with the 2019 EULAR/ACR classification criteria for SLE; SLEDAI-2K classification criteria: mildly active patients: SLEDAI score <= 6, hormones <= 10 mg/d, no immunosuppression; 2, Disease stability: fluctuation of SLEDAI score <= 2 in the 3 months prior to enrolment, and no recent ( within 1 month) treatment adjustments (especially hormone dose adjustments). 3. Physical function and adaptability to exercise: Cardiorespiratory fitness: no contraindications to exercise as assessed by the PAR-Q questionnaire; Musculoskeletal status: no severe arthritis, no history of osteonecrosis of the femoral head or osteoporosis; Ability to perform activities of daily living: ability to independently perform basic exercise (e.g., walking for 30 minutes) 4. Age 18-45 years old, female; 5. Vital signs were stable in the resting state (normal blood pressure, heart rate, and blood oxygen saturation); 6, Physicians and exercise specialists believe that participants are able to exercise safely; 7, Sign the informed consent form, voluntarily participate in the trial and complete the follow-up;
Exclusion criteria
Exclusion criteria: 1, Combination of other autoimmune diseases (such as rheumatoid arthritis, systemic sclerosis, ankylosing spondylitis, etc., except for dry syndrome) 2, Combination of serious complications, malignant tumours, or in the terminal stage of the disease; 3, Any acute infections, febrile illnesses, such as influenza, dysentery, pneumonia, etc.; 4, Drugs and treatment limitations: Patients with low-activity SLE have had the past 3 months to increase the lupus-specific drug preparation or dosage; Recent (= 20 mg/d or other equimetric hormones for more than 1 month); 5. Pregnant or breastfeeding females; 6. Presence of cognitive impairments or psychiatric disorders that prevent cooperation, or other inability to comprehend or carry out the exercise regimen (e.g., severe language impairment, visual impairment); 7. Failure to pass the PAR-Q questionnaire assessment; 8. Recent (<6 months) history of severe trauma or surgery; 9. Currently engaging in regular exercise on a weekly basis; 10. Patient is concurrently enrolled in another clinical trial study; 11. Anyone who, for any other reason, in the opinion of the investigator, is not appropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SLEDAI or SLEDAI-2k score from baseline to week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI or SLEDAI-2K score, change in steroid dosage from baseline to 24 weeks and 48 weeks;Achieving DORIS/LLDAS disease remission;Quality of Life-Related Indicators; Body Composition Analysis;Peripheral blood immune cell subsets;single-cell sequencing;RNA-Seq;immune repertoire;Serum inflammatory cytokine levels;serum metabolomics;Gut Microbiome;Exercise adherence;Other Laboratory Tests;Safety Metrics; | — |
Countries
China
Contacts
Public ContactHaijing Wu
The Second Xiangya Hospital of Central South University
Outcome results
None listed