Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07024082
Enrollment
130
Registered
2025-06-17
Start date
2025-08-09
Completion date
2025-12-01
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erthematosus

Keywords

Systemic lupus erythematosus, Water-based exercise

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 .

Interventions

OTHERLand-based Liuzijue exercise

This group includes 40 patients.Will be Performed twice a week from 9:00 to 10:00 a.m. in the rehabilitation department of Shanghai Yue-Yang Hospital under the guidance of an experienced instructor. The LG exercise program consisted of three parts: (1) Warm ups: 5-10 min of stretching and joint activity covering the limbs, neck, and trunk; (2) Land-based Liuzijue exercise: Liuzijue exercise consist of six distinct sounds (xu, he, hu, si, chui, and xi) and corresponding movements was performed with the knees in a semi-flexed position for 45 min; and the time to complete an intact Liuzijue exercise lasts 12-15 min; (3) Cool down: regulate breathing and relax muscles including flap and stretch muscles for 5-10 min.

OTHERWater-based Liuzijue exercise

This group includes 40 patients. Water-based Liuzijue exercise will be performed twice a week, from 1:00-2:00 p.m., between June and September 2016, in the thermostatic swimming pool located at Shanghai University of Sport (Shanghai, China). The temperature of swimming pool was between 26°C and 30°C, while the temperature of air was between 30°C and 34°C, and the relative humidity was between 60% and 80%. Circulating water purification and disinfection equipment coordinated with chlorine disinfectant was used to sterilize the pool water. The participants were immersed in water to a level between their xiphisternum (lowest part of the sternum) and clavicles. Water-based Liuzijue exercise requires that participants remain awake and have eaten no sooner than 1 h prior to entering the pool to exercise. The WG exercise program consisted of three parts similar with LG: (1) Warm ups; (2) Water-based Liuzijue exercise; and (3) Cool down.

Sponsors

MTI University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory exercise test: Peak VO2 (mL/minbase line and 12 weeksThe 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

MeasureTime frameDescription
Functional exercise capacitybase line and after 12 weeksAccording 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 densitybase line and after 12 weeksBMD (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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026