Physical ActivityFTSNCT03286725
Physical Exercise for Education ('Fit to Study')
A study testing Physical Education (PE) Programme in people with Physical Activity and Mental Health Wellness 1, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
Neuroscience evidence suggests that physical exercise can influence brain function and structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised controlled trial to test the effects on academic performance (as well as fitness, wellbeing and cognitive function) of a teacher-training… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Mental Health Wellness 1, Cognitive Function 1, Social
- What is being tested?
- Physical Education (PE) Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 1 Jul 2020
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Year 7 pupils during the academic year 2016/17 (Age 11-12, KS3).
- Year 8 pupils during the academic year 2017/18 (Age 12-13, KS3).
Who cannot join
- Any pupils that are exempted from PE.
- Pupils that have 'opted out' of data sharing / storage for research purposes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes University
Oxford, Oxfordshire, OX3 0BP
About this study
Neuroscience evidence suggests that physical exercise can influence brain function and structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised controlled trial to test the effects on academic performance (as well as fitness, wellbeing and cognitive function) of a teacher-training intervention designed to optimise the content of PE for brain and cognitive function during secondary school (Year 8) Physical Education (PE) lessons. The project aims to rigorously test the impact of this intervention in 100 state-funded secondary schools.
Read the detailed description
Physical exercise has been shown to have positive effects on the brain and to improve cognitive performance, both immediately and in the long-term. This project is being conducted to understand better how the content of school PE, focusing on Year8 pupils during the academic year 2017/18, affects brain function and structure, and academic performance.
A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme.
'Fit to Study' is aiming to recruit 100 state-funded secondary schools from within a radius of Oxford.
The National Foundation for Education Research will help with recruitment by sending materials to target schools, collating responses, collecting pupil information from schools that sign up, and passing information to the research teams and NatCen Social Research (who will be responsible for randomisation). Participating schools will be randomly assigned to either an Intervention Group (IG) and be asked to deliver the new PE programme, or to a Control Group (CG) and asked to continue with their normal PE lessons. Randomisation will be achieved using a random sequence generated using Stata12. Balance between treatment and control groups will be achieved across a range of covariates (i.e. to ensure not all girls schools are assigned to one condition).
For both Groups there will be a number of activities for schools to undertake, both at the start, during, and at the end of the study. The key tasks are listed, and then described, below:
- Online Cognitive Tests (pre- and post-study)
- Wellbeing Questionnaires (pre- and post-study)
- Physical Activity Assessments (before and during the study)
- PE Teacher Training for Intervention Schools
- Fitness (Beep) Tests (pre- and post-study)
- NatCen will undertake an Independent Evaluation of the 'Fit to Study' programme.
In all schools, the pupils in the target year group will undergo baseline assessments (in the final term of Year 7), which will comprise tests of physical fitness; cognitive assessments; and questionnaires (about physical activity, sleep patterns, mood, motivation and wellbeing). The tests of physical fitness will be administered during PE lessons and will involve measures of speed and endurance. The school PE teachers will be involved in the administration of these tests. The cognitive tests (which will include tests of memory, executive functions and attention using button responses), and some of the questionnaires, will be computer-based and may be administered over the web, at school or at home, using a well-established online testing package.
PE teachers in the intervention condition schools will be trained to administer our intervention. Our training package will comprise a set of focused lesson principles and techniques for their delivery.
To foster friendly competition between schools, the investigators may produce newsletters/bulletins containing school league tables indicating summary physical activity levels during PE and/or proportion of assessments completed, but these will never contain individual pupils' data.
The investigators will use activity monitors to compare physical activity during intervention and control PE lessons. At the end of the intervention period (which is intended to be an academic year), the Year 8 pupils in all schools will repeat the assessments.
In addition, the University of Oxford will be conducting a sub-study with a small number of pupils from a subset of schools. This is an optional part of the project and will be subject to separate written / informed consent from the pupils' parents/guardians. This will involve MRI brain scanning at the University of Oxford, as well as additional fitness and cognitive tests. Further detail will be made available to schools that are selected to take part in the Main Study (from May 2017).
- Conditions
- Physical Activity, Mental Health Wellness 1, Cognitive Function 1, Social, Academic Attainment, Fitness Testing
- Being tested
- Physical Education (PE) Programme
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Education (PE) ProgrammeBehavioural
A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme.
The Intervention involves roughly 20 minutes of prescribed activities per week, to be delivered within school PE lessons.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The Control Group will be asked to continue with their normal PE lessons. |
| Intervention Group | Experimental | 'Physical Education (PE) Programme' Receives: Behavioral: Physical Education (PE) Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018).
The Primary Outcome Measure is recorded on the ISRCTN registry with study ID ISRCTN15730512.
Mathematical attainment as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year.
Measured: 1 hour: Last month of the study (June 2018).
Secondary outcomes (8)
Wellbeing Survey
A battery of surveys each including a number of measures: adolescent mental health and wellbeing; daytime sleepiness; physical and global self-esteem; PE enjoyment; single measures of health-related quality of life and weekly moderate to vigorous physical activity (MVPA); attitudes, social norms, competence, intentions and willingness in relation to physical activity. Approximately 60 questions in total, taking 30 minutes to complete.
Measured: 30 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Attention and Reaction Time
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is an attention/ reaction-time task, to appearance of red triangles on the screen.
Measured: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Image Associates)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is an (image) association of place, person and object (memory) task.
Measured: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Eriksen Flanker Test
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a (modified) Eriksen Flanker task.
Measured: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Two-back Image Task)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a two-back image (memory) task (saying whether a picture is the same as the one before last).
Measured: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Executive Function
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a task-switching (executive function) task (arms up or arms down characters in relation to shape or colour questions).
Measured: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Fitness Assessment (20m Beep Test)
A distance of 20m is measured; cones are placed at lines indicating the distance. Pupils stand behind one of the lines facing the 2nd line, and begin running when instructed by an audio recording. The pupils continue running between the two lines, turning when signalled by the recorded beeps. After one minute, a sound indicates an increase in speed, and the beeps will be closer together. This continues each minute (level). If the line is reached before the beep sounds, the subject must wait until the beep sounds before continuing. If the line is not reached before the beep sounds, the subject is given a warning and must continue to run to the line, then turn and try to catch up with the pace within two more 'beeps'. The test is stopped if the subject fails to reach the line (within 2m) for two consecutive ends after a warning. Participants are instructed to remember the last number that was called before they stopped and tell the teacher who is recording the scores.
Measured: 20 minutes: Baseline (June 2017) and final month of the study (June 2018)
Physical Activity Measurements
All pupils will be provided with wrist-worn Axivity AX3 accelerometers, to be worn on the non-dominant wrist, to record their physical activity (PA) during a PE lesson. The AX3 is a tri-axial accelerometer which measures linear acceleration from +/- 2g to +/- 16g range along three orthogonal axes known as 'z' (upward and downward), 'y' (left and right) and 'x' (forward and backward).
Measured: 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 May 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2020
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 ActivityStudies 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
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Helen Dawes, Oxford Brookes University
- Investigators
- Helen Dawes, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286725
- Sponsor's protocol ID
- EEF2681
- Acronym
- FTS
- Status last verified
- Apr 2022
- First submitted
- 16 Aug 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On conclusion of the project, the Fischer Family Trust (see http://www.fft.org.uk/) will collate and upload anonymised data to the UK Data Archive (for the primary outcome measure). This archived data (for the primary outcome measure) will only be available in an anonymised form with restricted access for research purposes only.
Publications
Wassenaar TM, Wheatley CM, Beale N, Nichols T, Salvan P, Meaney A, Atherton K, Diaz-Ordaz K, Dawes H, Johansen-Berg H. The effect of a one-year vigorous physical activity intervention on fitness, cognitive performance and mental health in young adolescents: the Fit to Study cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2021 Mar 31;18(1):47. doi: 10.1186/s12966-021-01113-y.
PubMed 33789683Beale N, Eldridge E, Delextrat A, Esser P, Bushnell O, Curtis E, Wassenaar T, Wheatley C, Johansen-Berg H, Dawes H. Exploring activity levels in physical education lessons in the UK: a cross-sectional examination of activity types and fitness levels. BMJ Open Sport Exerc Med. 2021 Mar 9;7(1):e000924. doi: 10.1136/bmjsem-2020-000924. eCollection 2021.
PubMed 33768961Wassenaar TM, Wheatley CM, Beale N, Salvan P, Meaney A, Possee JB, Atherton KE, Duda JL, Dawes H, Johansen-Berg H. Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial. Trials. 2019 Apr 2;20(1):189. doi: 10.1186/s13063-019-3279-6.
PubMed 30940164
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise for Education ('Fit to Study')
- ClinicalTrials.gov ID
- NCT03286725
- Acronym / sponsor ID
- FTS / EEF2681
- Conditions
- Physical Activity, Mental Health Wellness 1, Cognitive Function 1, Social, Academic Attainment, Fitness Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Sep 2017 (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.
Neuroscience evidence suggests that physical exercise can influence brain function and structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised controlled trial to test the effects on academic performance (as well as fitness, wellbeing and cognitive function) of a teacher-training intervention designed to optimise the content of PE for brain and cognitive function during secondary school (Year 8) Physical Education (PE) lessons. The project aims to rigorously test the impact of this intervention in 100 state-funded secondary schools.
Detailed description
Physical exercise has been shown to have positive effects on the brain and to improve cognitive performance, both immediately and in the long-term. This project is being conducted to understand better how the content of school PE, focusing on Year8 pupils during the academic year 2017/18, affects brain function and structure, and academic performance.
A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme.
'Fit to Study' is aiming to recruit 100 state-funded secondary schools from within a radius of Oxford.
The National Foundation for Education Research will help with recruitment by sending materials to target schools, collating responses, collecting pupil information from schools that sign up, and passing information to the research teams and NatCen Social Research (who will be responsible for randomisation). Participating schools will be randomly assigned to either an Intervention Group (IG) and be asked to deliver the new PE programme, or to a Control Group (CG) and asked to continue with their normal PE lessons. Randomisation will be achieved using a random sequence generated using Stata12. Balance between treatment and control groups will be achieved across a range of covariates (i.e. to ensure not all girls schools are assigned to one condition).
For both Groups there will be a number of activities for schools to undertake, both at the start, during, and at the end of the study. The key tasks are listed, and then described, below:
- Online Cognitive Tests (pre- and post-study)
- Wellbeing Questionnaires (pre- and post-study)
- Physical Activity Assessments (before and during the study)
- PE Teacher Training for Intervention Schools
- Fitness (Beep) Tests (pre- and post-study)
- NatCen will undertake an Independent Evaluation of the 'Fit to Study' programme.
In all schools, the pupils in the target year group will undergo baseline assessments (in the final term of Year 7), which will comprise tests of physical fitness; cognitive assessments; and questionnaires (about physical activity, sleep patterns, mood, motivation and wellbeing). The tests of physical fitness will be administered during PE lessons and will involve measures of speed and endurance. The school PE teachers will be involved in the administration of these tests. The cognitive tests (which will include tests of memory, executive functions and attention using button responses), and some of the questionnaires, will be computer-based and may be administered over the web, at school or at home, using a well-established online testing package.
PE teachers in the intervention condition schools will be trained to administer our intervention. Our training package will comprise a set of focused lesson principles and techniques for their delivery.
To foster friendly competition between schools, the investigators may produce newsletters/bulletins containing school league tables indicating summary physical activity levels during PE and/or proportion of assessments completed, but these will never contain individual pupils' data.
The investigators will use activity monitors to compare physical activity during intervention and control PE lessons. At the end of the intervention period (which is intended to be an academic year), the Year 8 pupils in all schools will repeat the assessments.
In addition, the University of Oxford will be conducting a sub-study with a small number of pupils from a subset of schools. This is an optional part of the project and will be subject to separate written / informed consent from the pupils' parents/guardians. This will involve MRI brain scanning at the University of Oxford, as well as additional fitness and cognitive tests. Further detail will be made available to schools that are selected to take part in the Main Study (from May 2017).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The Control Group will be asked to continue with their normal PE lessons. |
| Intervention Group | Experimental | Behavioral: Physical Education (PE) Programme'Physical Education (PE) Programme' |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Year 7 pupils during the academic year 2016/17 (Age 11-12, KS3).
- Year 8 pupils during the academic year 2017/18 (Age 12-13, KS3).
Key exclusion criteria (2 listed)
- Any pupils that are exempted from PE.
- Pupils that have 'opted out' of data sharing / storage for research purposes
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 |
|---|---|---|
| Physical Education (PE) ProgrammeA programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme. The Intervention involves roughly 20 minutes of prescribed activities per week, to be delivered within school PE lessons. | Behavioural | Intervention Group |
Primary outcome
Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018).
Time frame: 1 hour: Last month of the study (June 2018).
The Primary Outcome Measure is recorded on the ISRCTN registry with study ID ISRCTN15730512. Mathematical attainment as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year.
8 secondary outcomes
Wellbeing Survey
Time frame: 30 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Attention and Reaction Time
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Image Associates)
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Eriksen Flanker Test
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Two-back Image Task)
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Executive Function
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Fitness Assessment (20m Beep Test)
Time frame: 20 minutes: Baseline (June 2017) and final month of the study (June 2018)
Physical Activity Measurements
Time frame: 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).
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 20 Apr 2022.
- Derived from this study: PubMed 33789683Wassenaar TM, Wheatley CM, Beale N, Nichols T, Salvan P, Meaney A, Atherton K, Diaz-Ordaz K, Dawes H, Johansen-Berg H. The effect of a one-year vigorous physical activity intervention on fitness, cognitive performance and mental health in young adolescents: the Fit to Study cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2021 Mar 31;18(1):47. doi: 10.1186/s12966-021-01113-y.
- Derived from this study: PubMed 33768961Beale N, Eldridge E, Delextrat A, Esser P, Bushnell O, Curtis E, Wassenaar T, Wheatley C, Johansen-Berg H, Dawes H. Exploring activity levels in physical education lessons in the UK: a cross-sectional examination of activity types and fitness levels. BMJ Open Sport Exerc Med. 2021 Mar 9;7(1):e000924. doi: 10.1136/bmjsem-2020-000924. eCollection 2021.
- Derived from this study: PubMed 30940164Wassenaar TM, Wheatley CM, Beale N, Salvan P, Meaney A, Possee JB, Atherton KE, Duda JL, Dawes H, Johansen-Berg H. Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial. Trials. 2019 Apr 2;20(1):189. doi: 10.1186/s13063-019-3279-6.
- Individual participant dataSharing planned: Yes. On conclusion of the project, the Fischer Family Trust (see http://www.fft.org.uk/) will collate and upload anonymised data to the UK Data Archive (for the primary outcome measure). This archived data (for the primary outcome measure) will only be available in an anonymised form with restricted access for research purposes only.
Related trials for Physical Activity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Not yet recruiting
Effects of Different Amounts of Plyometric Exercise Without Jumping in Physically Inactive Older Adults
Sedentary Behavior / Physical Inactivity, Aging
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.
Helen Dawes principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Education (PE) Programme in people with Physical Activity and Mental Health Wellness 1, run by Oxford Brookes University at 1 site in United Kingdom.
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 2 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 20 Apr 2022. 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 United Kingdom. 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?
Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018). (time frame: 1 hour: Last month of the study (June 2018).). 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 NCT03286725, 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 20 Apr 2022; AzTrials last refreshed its copy on 27 Oct 2026.