Water-based Liuzijue Exercise on Childhood-onset Systemic Lupus Erythematosus

Not Applicable

Not yet recruiting

• Conditions: Systemic Lupus Erthematosus

• Registration Number: NCT07024082
• Lead Sponsor: MTI University

Brief Summary

Systemic lupus erythematosus (SLE) is a life-long systemic autoimmune disease with a large variability in its clinical course. The onset of SLE during childhood and adolescence represents 10 to 20% of all SLE cases \[1\] and is associated with a more severe disease course compared to adult SLE. Due to earlier diagnosis as well as significant advances in the management of childhood-onset SLE (C-SLE), mortality rates have greatly decreased, with an estimated 5- to 10-year survival rate of over 85% \[2\].As a consequence, there has been a great increase in long-term co-morbidities, particularly cardiovascular disease (CVD), which is currently considered a major cause of long-term mortality in C-SLE patients \[3\].

Detailed Description

Systemic lupus erythematosus (SLE) is a life-long systemic autoimmune disease with a large variability in its clinical course. The onset of SLE during childhood and adolescence represents 10 to 20% of all SLE cases As a consequence, there has been a great increase in long-term co-morbidities, particularly cardiovascular disease (CVD), which is currently considered a major cause of long-term mortality in C-SLE patients. Liuzijue, which is one such traditional Chinese health exercise, is performed in expiration to produce six different sounds (xu, he, hu, si, chui, and xi) together with smooth movements of the upper and lower limbs .

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-08-25
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Age between 7 and 15 years
• Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score ≤ 16

Exclusion Criteria

• Neuropsychiatry involvement, hematologic abnormalitie
• cardiovascular rhythm and conduction disorders, musculoskeletal distur- bances that precluded participation in physical exercise
• pleuritis, pericarditis, endocarditis, acute kidney failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory exercise test: Peak VO2 (mL/min	base line and 12 weeks	The cardiorespiratory exercise test will be performed on a treadmill (Centurion, model 200, Micromed, Brazil), using a maximal graded exercise protocol \[30\]. The treadmill speed (2.0, 2.5, 3.0, 3.5, 4.0, 4.0, 4.0, 4.0, 5.0, 5.4, 5.9, 6.3, 6.3 mph), or grade (0.0, 0.0, 0.0, 0.0, 0.0, 2.5, 5.0, 7.5, 4.0, 4.0, 4.0, 4.0. 5.8%) will be increased every 1 minute. The recovery period was set at 2 minutes. Oxygen consumption (VO 2 ) and carbon dioxide output will be obtained through breath-by-breath sampling and expressed as a 30-second average using an indirect calorimetry system (Cortex, model Metalyzer III B, Leipzig, Germany).
Cardiorespiratory exercise test:Peak W (w) (working rate) (Watts)	base line and after 12 weeks
Cardiorespiratory exercise test:Chronotropic reserve (CR) %	base line and after 12 weeks	((CR) = (Peak HR - Resting HR/208 - (0.7 ∗ Age) - Resting HR\] × 100).

Secondary Outcome Measures

Name	Time	Method
Functional exercise capacity	base line and after 12 weeks	According to methods published by Ozalevli et al. \[29\], 30s sit-to-stand test (30 s SST) was conducted by participants. Participants sat on a 43 cm straight-backed seat, with the seat positioned against the wall to prevent falls. Participants' back was kept upright and hands were crossed so that they rested on the opposite shoulders. Before the test, participants were instructed to practice the procedure 1-2 times. During the 30 s, participants sat and stood as far as possible, and the repetitions were recorded.
Bone mineral density	base line and after 12 weeks	BMD (g/cm 2) will be determined by dual-energy x-ray absorptiometry (DXA), using a Hologic QDR 4500 Discovery densitometer (Hologic Inc., Bedford, MA, USA). Bone area (BA) (cm 2) will be calculated using the software provided with the densitometer. Bone mass will be analyzed in the lumbar spine (lumbar vertebrae L1 to L4), total femur, and whole body.