Skip to main content
OpenTrials
Completed

NCT Number: NCT07024082

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

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].

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Lupus Erthematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy ,Cairo University

Cairo, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Land-based Liuzijue exercise

Other

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.

Water-based Liuzijue exercise

Other

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.

Primary outcomes

  1. Cardiorespiratory exercise test: Peak VO2 (mL/min

    Time frame: 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).

  2. Cardiorespiratory exercise test:Peak W (w) (working rate) (Watts)

    Time frame: base line and after 12 weeks

  3. Cardiorespiratory exercise test:Chronotropic reserve (CR) %

    Time frame: base line and after 12 weeks

    ((CR) = (Peak HR - Resting HR/208 - (0.7 ∗ Age) - Resting HR] × 100).

Secondary outcomes

  1. Functional exercise capacity

    Time frame: 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.

  2. Bone mineral density

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.