Systemic Lupus ErthematosusNCT07024082
Water-based Liuzijue Exercise on Childhood-onset Systemic Lupus Erythematosus
A study testing Land-based Liuzijue exercise and Water-based Liuzijue exercise in people with Systemic Lupus Erthematosus, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Systemic Lupus Erthematosus
- What is being tested?
- Land-based Liuzijue exercise and Water-based Liuzijue exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Aug 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 7 and 15 years
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score ≤ 16
Who cannot join
- Neuropsychiatry involvement, hematologic abnormalitie
- cardiovascular rhythm and conduction disorders, musculoskeletal distur- bances that precluded participation in physical exercise
- pleuritis, pericarditis, endocarditis, acute kidney failure
Trial locations and contacts
1 site in 1 country.
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 [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].
Read the 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 .
- Conditions
- Systemic Lupus Erthematosus
- Being tested
- Land-based Liuzijue exercise, Water-based Liuzijue exercise
- Keywords
- Systemic lupus erythematosus, Water-based exercise
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Land-based Liuzijue exerciseOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Water-based Liuzijue exercise |
| Control group | No intervention | This group includes 40 patients, no exercise intervention. All participants received medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: base line and 12 weeks
Cardiorespiratory exercise test:Peak W (w) (working rate) (Watts)
Measured: base line and after 12 weeks
Cardiorespiratory exercise test:Chronotropic reserve (CR) %
((CR) = (Peak HR - Resting HR/208 - (0.7 ∗ Age) - Resting HR] × 100).
Measured: base line and after 12 weeks
Secondary outcomes (2)
Functional exercise capacity
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.
Measured: base line and after 12 weeks
Bone mineral density
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.
Measured: base line and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start9 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024082
- Sponsor's protocol ID
- P.T.REC/012/005817
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-based Liuzijue Exercise on Childhood-onset Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07024082
- Acronym / sponsor ID
- P.T.REC/012/005817
- Conditions
- Systemic Lupus Erthematosus
- Keywords
- Systemic lupus erythematosus, Water-based exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Land-based Liuzijue exercise | Experimental | Other: Land-based Liuzijue exerciseThis 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 | Experimental | Other: Water-based Liuzijue exercisehis 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. |
| Control group | No intervention | –This group includes 40 patients, no exercise intervention. All participants received medical treatment. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 7 and 15 years
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score ≤ 16
Key exclusion criteria (3 listed)
- Neuropsychiatry involvement, hematologic abnormalitie
- cardiovascular rhythm and conduction disorders, musculoskeletal distur- bances that precluded participation in physical exercise
- pleuritis, pericarditis, endocarditis, acute kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Land-based Liuzijue exerciseThis 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 exerciseThis 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 |
Primary outcome
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).
Cardiorespiratory exercise test:Peak W (w) (working rate) (Watts)
Time frame: base line and after 12 weeks
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).
2 secondary outcomes
Functional exercise capacity
Time frame: base line and after 12 weeks
Bone mineral density
Time frame: base line and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Land-based Liuzijue exercise and Water-based Liuzijue exercise in people with Systemic Lupus Erthematosus, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory exercise test: Peak VO2 (mL/min (time frame: base line and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.