Adolescent BehaviorNCT06164041
Training and Detraining Effects of a Physical Activity Program Implemented Through Mobile Applications in Adolescents.
A study testing The use of mobile applications promoted from the physical education classroom to improve adolescent health. in people with Adolescent Behavior and Mobile Applications, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The use of mobile applications to promote the practice of physical activity has begun to be used in the adolescent population in recent years. This has made it possible to carry out interventions inside and outside the educational setting, the latter being the ones that have brought the greatest benefits. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Mobile Applications, Physical Activity
- What is being tested?
- The use of mobile applications promoted from the physical education classroom to improve adolescent health.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2023to 21 Jul 2023
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- enrollment in one of the selected educational centers.
- age comprised between 12-16 years old.
- completion of all questionnaires and physical tests during the three measurement periods (T1, T2 and T3).
- attending the kinanthropometric and body composition measurement periods.
- absence of any pathology or injury that would hinder participation in the tests or measurements conducted.
Who cannot join
- missing more than 20% of the compulsory physical education sessions throughout the academic year.
- lack of mobile phone.
- failure to meet the minimum mandatory weekly distance requirement in the App group when app usage was obligatory.
- changing schools or class group during the course of the intervention.
- starting or ending any form of physical activity during the intervention that could alter the level of physical activity practiced for reasons unrelated to the study.
- having presented any illness during the follow-up period that would have prevented them from engaging in their usual physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training and Detraining Effects of a Ten-week Physical Activity Program Implemented Through Mobile Applications on Body Composition and Fitness of Adolescents Aged 12-16 Years.
The use of mobile applications to promote the practice of physical activity has begun to be used in the adolescent population in recent years. This has made it possible to carry out interventions inside and outside the educational setting, the latter being the ones that have brought the greatest benefits. Thus, it has been observed that the promotion of the use of mobile applications in out-of-school hours from the subject of physical education has reported significant benefits on body composition and fitness in the adolescent population. However, there is no known research that has analyzed whether the effect achieved with mobile applications when their use is mandatory disappears when they are no longer promoted from the physical education subject. Therefore, this project goes further and tries to find out whether after the ten-week period of mandatory use of the applications, adolescents continue to use the applications autonomously and the beneficial effects achieved are maintained or disappear due to the lack of use.
For this purpose, a 10-week intervention was planned in which the adolescents used the mobile applications. Prior to the start of the intervention, the adolescents' body composition and fitness (pre) were measured. At the end of the intervention of mandatory use of the mobile applications, the adolescents were measured again (post). And after the post measurement, the adolescents were left for 10 weeks during which they could use the applications autonomously. A third measurement of the adolescents was performed after this 10-week period (post 2).
The aim of this project was to find out the effects of stopping the use of the mobile fitness apps on body composition and fitness of the adolescents.
- Conditions
- Adolescent Behavior, Mobile Applications, Physical Activity, Physical Condition, Body Composition
- Being tested
- The use of mobile applications promoted from the physical education classroom to improve adolescent health.
- Medical subject headings
- Adolescent Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of mobile applications promoted from the physical education classroom to improve adolescent health.Behavioural
Before starting the intervention, a total of 465 adolescents participated in pretest measurements (T1).
Researchers in charge of explaining how the apps worked were not involved in the measurements or subsequent analysis, as they knew which student belonged to each App and control group. Once each app had been described and its use explained, a training plan was drawn up to be followed during the period of mandatory use.
The adolescents were motivated to utilize the app for a duration of ten weeks, aiming for a minimum usage of three times per week.
After the mandatory intervention with the mobile apps, post-test measurements were carried out (T2). Then, a period of 10 weeks was provided in which the use of the app was neither mandatory nor promoted from the physical education subject, after which the post-test 2 measurements (T3) were taken.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group did not use any of the research mobile applications, but were measured at pre, post and post 2. They continued attending physical education classes normally and practicing their sports activities. |
| Cardiovascular training through the application "MapMyWalk" | Experimental | The adolescents who used this application were required to record their weekly workouts. To do this, before starting the workout, they entered the application, selected "walking" and started the record. The application included different warnings and alerts to encourage the practice of physical activity. Each week they had to make a weekly report with the distance covered. Receives: Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health. |
| Cardiovascular training through the application "Strava" | Experimental | The adolescents who used this application were required to record their weekly workouts. To do this, before starting the workout, they entered the application, selected "walking" and started the record. The application included different warnings and alerts to encourage the practice of physical activity. Each week they had to make a weekly report with the distance covered. Receives: Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health. |
| Cardiovascular training through the application "Pacer" | Experimental | The adolescents who used this application were required to record their weekly workouts. To do this, before starting the workout, they entered the application, selected "walking" and started the record. The application included different warnings and alerts to encourage the practice of physical activity. Each week they had to make a weekly report with the distance covered. Receives: Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health. |
| Cardiovascular training through the application "Pokémon Go" | Experimental | This application is considered immersive as teenagers enter a virtual world. In it, the distance traveled in the real world was accounted for in the video game, also appearing different Pokémon that they could capture, making the gaming experience more playful. In the same way, the teenagers had to keep a weekly record of the distance traveled. Receives: Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level (International Physical Activity Questionnaire for Adolescents)
The Physical Activity Questionnaire for Adolescents will be used to establish the level of sports practice of the adolescents. This questionnaire includes eleven questions related to the practice of physical activity in school, after school, household chores and travel. The questionnaire makes it possible to classify adolescents as inactive or active (light, moderate or vigorous intensity).
Measured: Through study completion, an average of 1 year
Physical condition (Maximal oxygen consumption)
The 20-m shuttle run test evaluates maximal aerobic capacity by means of an incremental 20-meter out-and-back test. The initial speed of the test is 8.5 km/h and is increased every minute by an audible signal. The test ends when the subject stops or fails to reach the reference line two consecutive times. The speed recorded is the speed reached in the last stage that the subject is able to complete. Through the equations of Leger et al. the reference value of the subject's VO2 max. is obtained.
Measured: Through study completion, an average of 1 year
Physical condition (Lower extremity muscle strength)
The countermovement jump test (CMJ) will be used to measure this variable. This test provides information on the explosive strength of the lower body. The CMJ is a vertical jump that begins with the subject in a standing position, followed by knee flexion to a position of approximately 90 degrees, and a rapid extension of the knees to perform a jump in which the maximum height is reached. It should be noted that there is no stop in the knee flexion position since the intention is to take advantage of the explosive elastic reflex energy of the movement. The subjects will perform two repetitions of the jump 2 minutes apart. A MuscleLab force platform (Ergotest Innovation S.A., Norway) will be used to record the data, which will measure the time of flight from the time the subject takes off from the platform to the time the subject re-enters contact with the platform.
Measured: Through study completion, an average of 1 year
Physical condition (abdominal strength)
To assess abdominal muscle endurance will be use Curl-up. The highest number of repetitions the subject completes in one minute will be recorded.
Measured: Through study completion, an average of 1 year
Physical condition (upper extremity muscle strength)
To assess upper limb strength will be used Push-up test. The subject will perform as many repetitions as possible in one minute, or until reaching exhaustion.
Measured: Through study completion, an average of 1 year
Anthropometric Variables (Height)
To measure height, a SECA measuring rod should be used. Adolescents should stand barefoot with their backs against the measuring rod, heels of their feet together and their gaze straight ahead. Measurements will be obtained in centimeters and will be repeated 2 times for each subject. A third measurement will only be taken if the difference between the first and second measurement is greater than 1%.
Measured: Through study completion, an average of 1 year
Anthropometric Variables (Weight)
A Tanita BC 418-MA Segmental scale (Tanita, Tokyo) will be used to measure body weight. The subject will step on the scale with both feet inside the scale and looking straight ahead, without leaning the body. Values will be obtained in kilograms and two measurements will be carried out on each subject. If the difference between both measurements is greater than 1%, a third measurement will be taken.
Measured: Through study completion, an average of 1 year
Anthropometric Variables (Fat mass)
To obtain the fat mass, it will be necessary to previously measure the triceps, thigh and calf folds, and the waist, hip, relaxed arm, thigh and calf perimeters. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the fat mass can be calculated using the formula of Slaughter et al.
Measured: Through study completion, an average of 1 year
Anthropometric Variables (Fat-free mass)
To obtain the fat-free mass, it will be necessary to previously measure the triceps, thigh and leg folds, and the perimeters of the waist, hip, relaxed arm, thigh and leg. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the-fat free mass can be calculated using the formula of Poortmans et al.
Measured: Through study completion, an average of 1 year
Anthropometric Variables (BMI)
Previously obtained height and weight measurements will be used to establish the BMI. The formula used will be weight/height^2, and the result will be obtained in kg/m^2. This index is commonly used and is related to metabolic and cardiovascular diseases in adolescents and adults.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start9 Jan 2023
- Primary completion9 Jun 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Vaquero-Cristóbal, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164041
- Sponsor's protocol ID
- MobileApps-Re
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mateo-Orcajada A, Vaquero-Cristobal R, Mota J, Abenza-Cano L. Physical Activity, Body Composition, and Fitness Variables in Adolescents After Periods of Mandatory, Promoted or Nonmandatory, Nonpromoted Use of Step Tracker Mobile Apps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jul 30;12:e51206. doi: 10.2196/51206.
PubMed 39079110
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training and Detraining Effects of a Ten-week Physical Activity Program Implemented Through Mobile Applications on Body Composition and Fitness of Adolescents Aged 12-16 Years.
- ClinicalTrials.gov ID
- NCT06164041
- Acronym / sponsor ID
- MobileApps-Re
- Conditions
- Adolescent Behavior, Mobile Applications, Physical Activity, Physical Condition, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 11 Dec 2023 (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.
The use of mobile applications to promote the practice of physical activity has begun to be used in the adolescent population in recent years. This has made it possible to carry out interventions inside and outside the educational setting, the latter being the ones that have brought the greatest benefits. Thus, it has been observed that the promotion of the use of mobile applications in out-of-school hours from the subject of physical education has reported significant benefits on body composition and fitness in the adolescent population. However, there is no known research that has analyzed whether the effect achieved with mobile applications when their use is mandatory disappears when they are no longer promoted from the physical education subject. Therefore, this project goes further and tries to find out whether after the ten-week period of mandatory use of the applications, adolescents continue to use the applications autonomously and the beneficial effects achieved are maintained or disappear due to the lack of use.
For this purpose, a 10-week intervention was planned in which the adolescents used the mobile applications. Prior to the start of the intervention, the adolescents' body composition and fitness (pre) were measured. At the end of the intervention of mandatory use of the mobile applications, the adolescents were measured again (post). And after the post measurement, the adolescents were left for 10 weeks during which they could use the applications autonomously. A third measurement of the adolescents was performed after this 10-week period (post 2).
The aim of this project was to find out the effects of stopping the use of the mobile fitness apps on body composition and fitness of the adolescents.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group did not use any of the research mobile applications, but were measured at pre, post and post 2. They continued attending physical education classes normally and practicing their sports activities. |
| Cardiovascular training through the application "MapMyWalk" | Experimental | Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health.The adolescents who used this application were required to record their weekly workouts. To do this, before starting the workout, they entered the application, selected "walking" and started the record. The application included different warnings and alerts to encourage the practice of physical activity. Each week they had to make a weekly report with the distance covered. |
| Cardiovascular training through the application "Strava" | Experimental | Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health.The adolescents who used this application were required to record their weekly workouts. To do this, before starting the workout, they entered the application, selected "walking" and started the record. The application included different warnings and alerts to encourage the practice of physical activity. Each week they had to make a weekly report with the distance covered. |
| Cardiovascular training through the application "Pacer" | Experimental | Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health.The adolescents who used this application were required to record their weekly workouts. To do this, before starting the workout, they entered the application, selected "walking" and started the record. The application included different warnings and alerts to encourage the practice of physical activity. Each week they had to make a weekly report with the distance covered. |
| Cardiovascular training through the application "Pokémon Go" | Experimental | Behavioral: The use of mobile applications promoted from the physical education classroom to improve adolescent health.This application is considered immersive as teenagers enter a virtual world. In it, the distance traveled in the real world was accounted for in the video game, also appearing different Pokémon that they could capture, making the gaming experience more playful. In the same way, the teenagers had to keep a weekly record of the distance traveled. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- enrollment in one of the selected educational centers.
- age comprised between 12-16 years old.
- completion of all questionnaires and physical tests during the three measurement periods (T1, T2 and T3).
- attending the kinanthropometric and body composition measurement periods.
- absence of any pathology or injury that would hinder participation in the tests or measurements conducted.
Key exclusion criteria (6 listed)
- missing more than 20% of the compulsory physical education sessions throughout the academic year.
- lack of mobile phone.
- failure to meet the minimum mandatory weekly distance requirement in the App group when app usage was obligatory.
- changing schools or class group during the course of the intervention.
- starting or ending any form of physical activity during the intervention that could alter the level of physical activity practiced for reasons unrelated to the study.
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 |
|---|---|---|
| The use of mobile applications promoted from the physical education classroom to improve adolescent health.Before starting the intervention, a total of 465 adolescents participated in pretest measurements (T1). Researchers in charge of explaining how the apps worked were not involved in the measurements or subsequent analysis, as they knew which student belonged to each App and control group. Once each app had been described and its use explained, a training plan was drawn up to be followed during the period of mandatory use. The adolescents were motivated to utilize the app for a duration of ten weeks, aiming for a minimum usage of three times per week. After the mandatory intervention with the mobile apps, post-test measurements were carried out (T2). Then, a period of 10 weeks was provided in which the use of the app was neither mandatory nor promoted from the physical education subject, after which the post-test 2 measurements (T3) were taken. | Behavioural | Cardiovascular training through the application "MapMyWalk", Cardiovascular training through the application "Pacer", Cardiovascular training through the application "Pokémon Go", Cardiovascular training through the application "Strava" |
Primary outcome
Physical Activity Level (International Physical Activity Questionnaire for Adolescents)
Time frame: Through study completion, an average of 1 year
The Physical Activity Questionnaire for Adolescents will be used to establish the level of sports practice of the adolescents. This questionnaire includes eleven questions related to the practice of physical activity in school, after school, household chores and travel. The questionnaire makes it possible to classify adolescents as inactive or active (light, moderate or vigorous intensity).
Physical condition (Maximal oxygen consumption)
Time frame: Through study completion, an average of 1 year
The 20-m shuttle run test evaluates maximal aerobic capacity by means of an incremental 20-meter out-and-back test. The initial speed of the test is 8.5 km/h and is increased every minute by an audible signal. The test ends when the subject stops or fails to reach the reference line two consecutive times. The speed recorded is the speed reached in the last stage that the subject is able to complete. Through the equations of Leger et al. the reference value of the subject's VO2 max. is obtained.
Physical condition (Lower extremity muscle strength)
Time frame: Through study completion, an average of 1 year
The countermovement jump test (CMJ) will be used to measure this variable. This test provides information on the explosive strength of the lower body. The CMJ is a vertical jump that begins with the subject in a standing position, followed by knee flexion to a position of approximately 90 degrees, and a rapid extension of the knees to perform a jump in which the maximum height is reached. It should be noted that there is no stop in the knee flexion position since the intention is to take advantage of the explosive elastic reflex energy of the movement. The subjects will perform two repetitions of the jump 2 minutes apart. A MuscleLab force platform (Ergotest Innovation S.A., Norway) will be used to record the data, which will measure the time of flight from the time the subject takes off from the platform to the time the subject re-enters contact with the platform.
Physical condition (abdominal strength)
Time frame: Through study completion, an average of 1 year
To assess abdominal muscle endurance will be use Curl-up. The highest number of repetitions the subject completes in one minute will be recorded.
Physical condition (upper extremity muscle strength)
Time frame: Through study completion, an average of 1 year
To assess upper limb strength will be used Push-up test. The subject will perform as many repetitions as possible in one minute, or until reaching exhaustion.
Anthropometric Variables (Height)
Time frame: Through study completion, an average of 1 year
To measure height, a SECA measuring rod should be used. Adolescents should stand barefoot with their backs against the measuring rod, heels of their feet together and their gaze straight ahead. Measurements will be obtained in centimeters and will be repeated 2 times for each subject. A third measurement will only be taken if the difference between the first and second measurement is greater than 1%.
Anthropometric Variables (Weight)
Time frame: Through study completion, an average of 1 year
A Tanita BC 418-MA Segmental scale (Tanita, Tokyo) will be used to measure body weight. The subject will step on the scale with both feet inside the scale and looking straight ahead, without leaning the body. Values will be obtained in kilograms and two measurements will be carried out on each subject. If the difference between both measurements is greater than 1%, a third measurement will be taken.
Anthropometric Variables (Fat mass)
Time frame: Through study completion, an average of 1 year
To obtain the fat mass, it will be necessary to previously measure the triceps, thigh and calf folds, and the waist, hip, relaxed arm, thigh and calf perimeters. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the fat mass can be calculated using the formula of Slaughter et al.
Anthropometric Variables (Fat-free mass)
Time frame: Through study completion, an average of 1 year
To obtain the fat-free mass, it will be necessary to previously measure the triceps, thigh and leg folds, and the perimeters of the waist, hip, relaxed arm, thigh and leg. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the-fat free mass can be calculated using the formula of Poortmans et al.
Anthropometric Variables (BMI)
Time frame: Through study completion, an average of 1 year
Previously obtained height and weight measurements will be used to establish the BMI. The formula used will be weight/height^2, and the result will be obtained in kg/m^2. This index is commonly used and is related to metabolic and cardiovascular diseases in adolescents and adults.
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 11 Dec 2023.
- Derived from this study: PubMed 39079110Mateo-Orcajada A, Vaquero-Cristobal R, Mota J, Abenza-Cano L. Physical Activity, Body Composition, and Fitness Variables in Adolescents After Periods of Mandatory, Promoted or Nonmandatory, Nonpromoted Use of Step Tracker Mobile Apps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jul 30;12:e51206. doi: 10.2196/51206.
- 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 The use of mobile applications promoted from the physical education classroom to improve adolescent health. in people with Adolescent Behavior and Mobile Applications, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 5 inclusion and 6 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 11 Dec 2023. 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 Spain. 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?
Physical Activity Level (International Physical Activity Questionnaire for Adolescents) (time frame: Through study completion, an average of 1 year). The study lists 10 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 NCT06164041, which also lists 1 linked publication.
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 11 Dec 2023; AzTrials last refreshed its copy on 29 Oct 2026.