Physical FitnessNCT06364995
Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance
A study testing Volleyball and Traditional Physical Education in people with Physical Fitness and Performance, run by Universiti Putra Malaysia at 1 site in China.
Trial summary
Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Performance
- What is being tested?
- Volleyball and Traditional Physical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 5 Jul 2024
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age and Education Level: Must be third-year students currently enrolled in a junior middle school.
- Need Students who took The PE entrance examination forsenior high school performance in Sichuan Province.
- Health Status: confirming the absence of any acute illnesses or physical impairments that could impair test performance.
- Physical Ability: Must be capable of performing all test activities designed for the study.
Who cannot join
- 1. Chronic Organ Diseases: Students with a documented history of chronic organ diseases, such as liver cirrhosis, chronic kidney disease, or others that could impact physical performance or require ongoing medical intervention, are excluded.
- 2. Cardiovascular Conditions: Students with any form of heart disease, including but not limited to congenital heart defects, arrhythmias, or history of myocardial infarction, are excluded.
- 3. Chronic Illness: Students with any chronic illnesses that could impair their ability to participate fully in the physical tests or that could be exacerbated by physical exertion, including but not limited to asthma, severe allergies, or diabetes requiring insulin management, are excluded.
- 4. Physical Disabilities: Students with congenital disabilities or physical impairments that prevent full participation in the study's required physical activities are excluded. This includes, but is not limited to, mobility impairments, significant musculoskeletal disorders, or other conditions that limit physical activity or exercise capacity.
- 5. Medical: Students must not have any medical conditions or take any medications that, in the opinion of a medical professional, would make participation in the study unsafe or interfere with the interpretation of the test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yimou MAO
Chengdu, Sichuan, 610044
Yimou MAO, PHD, 912327111@qq.com
About this study
Official title: Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance in Sichuan Province
Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Volleyball offers a blend of aerobic and anaerobic exercises, developing muscle strength, bone density, cardiovascular health, and fine-tuning the nervous system. It is effective in improving physical attributes such as strength, speed, agility, endurance, and coordination, which are crucial for holistic student development and success in the standardized PE entrance examinations for senior high school.
Recent trends have highlighted a decline in physical fitness among youth, as evidenced by rising obesity rates and increasing failure rates in fitness assessments. To counteract this, the Ministry of Education of the People's Republic of China 2021 has initiated a shift towards "specialised physical education," integrating health knowledge with basic and specialised motor skills training. This innovative educational model hopes to improve student physical fitness across educational tiers.
Therefore, this study chose volleyball specialised physical education as an intervention to study the effect of physical fitness and The PE entrance examination for senior high school performance of middle school students.
Read the detailed description
This study employed a Cluster Randomized Controlled Trial (CRCT) design, conducted across two middle schools in Chengdu City, Sichuan Province, China. The investigators systematically assigned an experimental group to undergo a meticulously structured 10-week specialised volleyball physical education program, tailored according to rigorous research protocol. Parallel to this, the control group participated in a traditional physical education curriculum.
The experimental group engaged in a targeted training regimen focused on elevating volleyball competencies. The program was carefully segmented into four distinct developmental phases, ensuring a gradual and measurable enhancement of skills. Each session maintained strict adherence to a prescribed intensity gradient, incorporating exercises that evolved from low to high intensity, simple to complex executions, and individual techniques to holistic gameplay.
The intervention unfolded as follows:
Warm-up (10 min): A series of dynamic activities designed to prepare the body for rigorous physical activity, emphasizing mobility and injury prevention.
Basic contents of PE lesson (25 min): This segment included a progressive suite of volleyball drills and exercises, fine-tuned to fortify foundational skills during the initial weeks and gradually introducing strategic elements as the weeks advanced. Skill refinement, tactical understanding, and technical proficiency were paramount throughout the phases.
Cool-down (5 min): Post-training activities focused on lowering heart rate and stretching to aid recovery, reduce muscle soreness, and improve flexibility.
The four progressive phases of the intervention were as follows:
Phase 1 (1-2 weeks) Foundational Technique Acquisition Phase 2 (3-5 weeks) Skill Refinement and Expansion Phase 3 (6-8 weeks) Advanced Techniques and Tactical Application Phase 4 (9-10 weeks) Competitive Play and Specialisation.
To measure the impact of this intervention, pre-test was conducted to establish baseline data before the experiment, and post-test was delivered after the tenth week. The testing protocol aimed to capture the progression in both physical fitness and proformance, providing a comparative analysis between the specialised physical education intervention and traditional physical education approach.
- Conditions
- Physical Fitness, Performance
- Being tested
- Volleyball, Traditional Physical Education
- Keywords
- physical fitness, performance, Volleyball specialised physical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolleyballBehavioural
Volleyball Specialised Physical Education Intervention is a step-by-step approach to teaching the intervention. Each lesson was conducted as a Warm-up (10 minutes), Basic contents of the PE lesson (25 minutes), and Cool-down (5 minutes). From the learning of basic skills in the first session to the final Combination Practice underhand service, receive, service, pass, spiking, and block, from the simple to the difficult, the intensity of the training is from weak to strong, Allowing participants to build upon a solid foundation toward mastering intricate volleyball maneuvers. Intensity modulation is key to this intervention; training intensity evolves from moderate to vigorous, aligning with the increasing complexity of skills and the physical demand required to execute them proficiently. The curriculum is thoughtfully designed to transition from basic skill execution to complex gameplay, with each lesson introducing new skills or refining existing ones.
Traditional Physical EducationBehavioural
Participants participating in the control group will attend traditional physical education classes following the established physical education syllabus. Participants in the control group will attend four 40-minute classes per week over ten weeks. Each session will consist of a warm-up (10 minutes), the basics of PE (25 minutes), and a cool-down (5 minutes). The duration and intensity of the experimental and control groups were the same, which allowed for a better comparison.
| Study group | Role | What they receive |
|---|---|---|
| Volleyball specialised physical education | Experimental | Volleyball specialised physical education intervention in weeks 1-10 of the experiment Receives: Behavioral: Volleyball |
| Traditional Physical Education | Active comparator | This arm is the control group receiving a traditional Physical Education program， Over 10 weeks, participants will engage in regular physical education sessions that include volleyball training Receives: Behavioral: Traditional Physical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of physical fitness of middle school students
By the physical fitness ,all the test outcomes and testing content are assessed using the "National Physical Fitness Test Standards for Students" China, 2014. The tests included are Spirometry Testing (FVC), 800m Run for Girls / 1000m Run for Boys, 1-minute Sit-Ups for Girls / Pull-Ups for Boys, Standing Long Jump Test, and Body Mass Index (BMI). Participants undergo an initial test before the intervention begins, and a retest after the 10-week intervention period. The researcher will conduct these tests according to assessment metrics, all test results are standardized quantification according to the "National Physical Fitness Test Standards for Students" China, 2014,and the test results are classified into four levels: 10-50 points (fail), 60-78 points (pass), 80-85 points (good), and 90-100 points (excellent).
Measured: Pretest: Before experiment;Post test:10 weeks end
Effects on middle school students' PE entrance examination for senior high school test performance
The PE entrance examination for senior high school test performance is according to the Sichuan Provincial Department of Education's guidelines for 2022, the scores of high school physical education entrance exams will pass Volleyball dig against the wall; 800m run (Girls); 1000m run (Boys); Pull-ups (girls); Incline pull-ups (girl); Standing Long Jump test. These test taken and quantified on a scale of (10；15；20；25；30；35；40；45；50；55；60；65；70；75；80；85；90；95；100 points). after the test. After the 10-week intervention period, the Investigator will be tested against the assessment metrics, and the Participant's score will be converted to a score that meets this criteria based on the Participant's test results. Each of these tests will be scored according to a standardized scale ranging from 10 to 100 points, with higher scores indicating superior performance.
Measured: Pretest: Before experiment;Post test:10 weeks end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start10 Jan 2024
- Primary completion28 Jun 2024 (estimated)
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical FitnessStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In this experiment, the experimental group used the intervention of specialised physical education teaching of volleyball. However, the control group only conducted traditional physical education teaching content
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAO YIMOU, Universiti Putra Malaysia
- Investigators
- Yimou MAO, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364995
- Sponsor's protocol ID
- JKEUPM-2023-1364
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Since this is my doctoral thesis experiment, I won't share it until I graduate.
Publications
Pereira A, Costa AM, Santos P, Figueiredo T, Joao PV. Training strategy of explosive strength in young female volleyball players. Medicina (Kaunas). 2015;51(2):126-31. doi: 10.1016/j.medici.2015.03.004. Epub 2015 Apr 1.
PubMed 25975882Stojanovic D, Momcilovic V, Zadraznik M, Ilic I, Konicanin A, Padulo J, Russo L, Stojanovic T. School-Based TGfU Volleyball Intervention Improves Physical Fitness and Body Composition in Primary School Students: A Cluster-Randomized Trial. Healthcare (Basel). 2023 May 30;11(11):1600. doi: 10.3390/healthcare11111600.
PubMed 37297741Hu WN, Li DY, Lam WK, Wang Y, Wong DW, Cheung JC. Physical Fitness of Chinese Primary School Students across the Coronavirus (COVID-19) Outbreak: A Retrospective Repeated Cross-Sectional Study. Int J Environ Res Public Health. 2022 Jun 27;19(13):7870. doi: 10.3390/ijerph19137870.
PubMed 35805528
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance in Sichuan Province
- ClinicalTrials.gov ID
- NCT06364995
- Acronym / sponsor ID
- JKEUPM-2023-1364
- Conditions
- Physical Fitness, Performance
- Keywords
- physical fitness, performance, Volleyball specialised physical education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 15 Apr 2024 (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.
Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Volleyball offers a blend of aerobic and anaerobic exercises, developing muscle strength, bone density, cardiovascular health, and fine-tuning the nervous system. It is effective in improving physical attributes such as strength, speed, agility, endurance, and coordination, which are crucial for holistic student development and success in the standardized PE entrance examinations for senior high school.
Recent trends have highlighted a decline in physical fitness among youth, as evidenced by rising obesity rates and increasing failure rates in fitness assessments. To counteract this, the Ministry of Education of the People's Republic of China 2021 has initiated a shift towards "specialised physical education," integrating health knowledge with basic and specialised motor skills training. This innovative educational model hopes to improve student physical fitness across educational tiers.
Therefore, this study chose volleyball specialised physical education as an intervention to study the effect of physical fitness and The PE entrance examination for senior high school performance of middle school students.
Detailed description
This study employed a Cluster Randomized Controlled Trial (CRCT) design, conducted across two middle schools in Chengdu City, Sichuan Province, China. The investigators systematically assigned an experimental group to undergo a meticulously structured 10-week specialised volleyball physical education program, tailored according to rigorous research protocol. Parallel to this, the control group participated in a traditional physical education curriculum.
The experimental group engaged in a targeted training regimen focused on elevating volleyball competencies. The program was carefully segmented into four distinct developmental phases, ensuring a gradual and measurable enhancement of skills. Each session maintained strict adherence to a prescribed intensity gradient, incorporating exercises that evolved from low to high intensity, simple to complex executions, and individual techniques to holistic gameplay.
The intervention unfolded as follows:
Warm-up (10 min): A series of dynamic activities designed to prepare the body for rigorous physical activity, emphasizing mobility and injury prevention.
Basic contents of PE lesson (25 min): This segment included a progressive suite of volleyball drills and exercises, fine-tuned to fortify foundational skills during the initial weeks and gradually introducing strategic elements as the weeks advanced. Skill refinement, tactical understanding, and technical proficiency were paramount throughout the phases.
Cool-down (5 min): Post-training activities focused on lowering heart rate and stretching to aid recovery, reduce muscle soreness, and improve flexibility.
The four progressive phases of the intervention were as follows:
Phase 1 (1-2 weeks) Foundational Technique Acquisition Phase 2 (3-5 weeks) Skill Refinement and Expansion Phase 3 (6-8 weeks) Advanced Techniques and Tactical Application Phase 4 (9-10 weeks) Competitive Play and Specialisation.
To measure the impact of this intervention, pre-test was conducted to establish baseline data before the experiment, and post-test was delivered after the tenth week. The testing protocol aimed to capture the progression in both physical fitness and proformance, providing a comparative analysis between the specialised physical education intervention and traditional physical education approach.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this experiment, the experimental group used the intervention of specialised physical education teaching of volleyball. However, the control group only conducted traditional physical education teaching content
| Arm | Type | Receives |
|---|---|---|
| Volleyball specialised physical education | Experimental | Behavioral: VolleyballVolleyball specialised physical education intervention in weeks 1-10 of the experiment |
| Traditional Physical Education | Active comparator | Behavioral: Traditional Physical EducationThis arm is the control group receiving a traditional Physical Education program， Over 10 weeks, participants will engage in regular physical education sessions that include volleyball training |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age and Education Level: Must be third-year students currently enrolled in a junior middle school.
- Need Students who took The PE entrance examination forsenior high school performance in Sichuan Province.
- Health Status: confirming the absence of any acute illnesses or physical impairments that could impair test performance.
- Physical Ability: Must be capable of performing all test activities designed for the study.
Key exclusion criteria (5 listed)
- 1. Chronic Organ Diseases: Students with a documented history of chronic organ diseases, such as liver cirrhosis, chronic kidney disease, or others that could impact physical performance or require ongoing medical intervention, are excluded.
- 2. Cardiovascular Conditions: Students with any form of heart disease, including but not limited to congenital heart defects, arrhythmias, or history of myocardial infarction, are excluded.
- 3. Chronic Illness: Students with any chronic illnesses that could impair their ability to participate fully in the physical tests or that could be exacerbated by physical exertion, including but not limited to asthma, severe allergies, or diabetes requiring insulin management, are excluded.
- 4. Physical Disabilities: Students with congenital disabilities or physical impairments that prevent full participation in the study's required physical activities are excluded. This includes, but is not limited to, mobility impairments, significant musculoskeletal disorders, or other conditions that limit physical activity or exercise capacity.
- 5. Medical: Students must not have any medical conditions or take any medications that, in the opinion of a medical professional, would make participation in the study unsafe or interfere with the interpretation of the test results.
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 |
|---|---|---|
| VolleyballVolleyball Specialised Physical Education Intervention is a step-by-step approach to teaching the intervention. Each lesson was conducted as a Warm-up (10 minutes), Basic contents of the PE lesson (25 minutes), and Cool-down (5 minutes). From the learning of basic skills in the first session to the final Combination Practice underhand service, receive, service, pass, spiking, and block, from the simple to the difficult, the intensity of the training is from weak to strong, Allowing participants to build upon a solid foundation toward mastering intricate volleyball maneuvers. Intensity modulation is key to this intervention; training intensity evolves from moderate to vigorous, aligning with the increasing complexity of skills and the physical demand required to execute them proficiently. The curriculum is thoughtfully designed to transition from basic skill execution to complex gameplay, with each lesson introducing new skills or refining existing ones. | Behavioural | Volleyball specialised physical education |
| Traditional Physical EducationParticipants participating in the control group will attend traditional physical education classes following the established physical education syllabus. Participants in the control group will attend four 40-minute classes per week over ten weeks. Each session will consist of a warm-up (10 minutes), the basics of PE (25 minutes), and a cool-down (5 minutes). The duration and intensity of the experimental and control groups were the same, which allowed for a better comparison. | Behavioural | Traditional Physical Education |
Primary outcome
Effects of physical fitness of middle school students
Time frame: Pretest: Before experiment;Post test:10 weeks end
By the physical fitness ,all the test outcomes and testing content are assessed using the "National Physical Fitness Test Standards for Students" China, 2014. The tests included are Spirometry Testing (FVC), 800m Run for Girls / 1000m Run for Boys, 1-minute Sit-Ups for Girls / Pull-Ups for Boys, Standing Long Jump Test, and Body Mass Index (BMI). Participants undergo an initial test before the intervention begins, and a retest after the 10-week intervention period. The researcher will conduct these tests according to assessment metrics, all test results are standardized quantification according to the "National Physical Fitness Test Standards for Students" China, 2014,and the test results are classified into four levels: 10-50 points (fail), 60-78 points (pass), 80-85 points (good), and 90-100 points (excellent).
Effects on middle school students' PE entrance examination for senior high school test performance
Time frame: Pretest: Before experiment;Post test:10 weeks end
The PE entrance examination for senior high school test performance is according to the Sichuan Provincial Department of Education's guidelines for 2022, the scores of high school physical education entrance exams will pass Volleyball dig against the wall; 800m run (Girls); 1000m run (Boys); Pull-ups (girls); Incline pull-ups (girl); Standing Long Jump test. These test taken and quantified on a scale of (10；15；20；25；30；35；40；45；50；55；60；65；70；75；80；85；90；95；100 points). after the test. After the 10-week intervention period, the Investigator will be tested against the assessment metrics, and the Participant's score will be converted to a score that meets this criteria based on the Participant's test results. Each of these tests will be scored according to a standardized scale ranging from 10 to 100 points, with higher scores indicating superior performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 25975882Pereira A, Costa AM, Santos P, Figueiredo T, Joao PV. Training strategy of explosive strength in young female volleyball players. Medicina (Kaunas). 2015;51(2):126-31. doi: 10.1016/j.medici.2015.03.004. Epub 2015 Apr 1.
- Background: PubMed 37297741Stojanovic D, Momcilovic V, Zadraznik M, Ilic I, Konicanin A, Padulo J, Russo L, Stojanovic T. School-Based TGfU Volleyball Intervention Improves Physical Fitness and Body Composition in Primary School Students: A Cluster-Randomized Trial. Healthcare (Basel). 2023 May 30;11(11):1600. doi: 10.3390/healthcare11111600.
- Background: PubMed 35805528Hu WN, Li DY, Lam WK, Wang Y, Wong DW, Cheung JC. Physical Fitness of Chinese Primary School Students across the Coronavirus (COVID-19) Outbreak: A Retrospective Repeated Cross-Sectional Study. Int J Environ Res Public Health. 2022 Jun 27;19(13):7870. doi: 10.3390/ijerph19137870.
- This article is from National Library of Medicine.Link provided by the sponsor.
- This article is from National Library of Medicine.Link provided by the sponsor.
- This article is from National Library of Medicine.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No Since this is my doctoral thesis experiment, I won't share it until I graduate.
Related trials for Physical Fitness
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Not yet recruiting
Integrating Sport-Specific Comprehensive Training to Upscale Performance in Women and Girls
Sport Injuries, Performance in Sport
Enrolling by invitationObservational study
Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Cardiometabolic Health
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.
Yimou MAO principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volleyball and Traditional Physical Education in people with Physical Fitness and Performance, run by Universiti Putra Malaysia at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimou MAO, PHD (8618349273912, 912327111@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of physical fitness of middle school students (time frame: Pretest: Before experiment;Post test:10 weeks end). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364995, which also lists 3 linked publications.
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 16 Apr 2024.