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

NCT07024082 | Completed

• 1 other identifier: P.T.REC/012/005817
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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 \[3\].

Conditions

Systemic Lupus Erthematosus

Keywords

Systemic lupus erythematosus; Water-based exercise

Outcome Measures

Primary Outcomes (3)

• Cardiorespiratory exercise test: Peak VO2 (mL/min

  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).

  base line and 12 weeks

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

  base line and after 12 weeks

• Cardiorespiratory exercise test:Chronotropic reserve (CR) %

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

  base line and after 12 weeks

Secondary Outcomes (2)

• Functional exercise capacity

  base line and after 12 weeks

• Bone mineral density

  base line and after 12 weeks

Study Arms (3)

Land-based Liuzijue exercise

EXPERIMENTAL

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.

Other: Land-based Liuzijue exercise

Water-based Liuzijue exercise

EXPERIMENTAL

his 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.

Other: Water-based Liuzijue exercise

Control group

NO INTERVENTION

This group includes 40 patients, no exercise intervention. All participants received medical treatment.

Interventions

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.

Land-based Liuzijue exercise

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.

Water-based Liuzijue exercise

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor at Physical Therapy department , Faculty of Applied Medical Sciences ,Al -Zaytoonah University of Jordan

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: August 9, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)