Juvenile Idiopathic ArthritisTHE_JIANCT05114343
Effectiveness and Feasibility of a Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis
A study testing Exercise in people with Juvenile Idiopathic Arthritis and Juvenile Arthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will aim to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescents (< 18 years) with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Juvenile Arthritis, Juvenile Rheumatoid Arthritis
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2021to Apr 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with polyarticular or oligoarticular subtypes of juvenile idiopathic arthritis.
Who cannot join
- Cardiovascular, metabolic, pulmonary or renal diseases
- Untreat thyroid disease
- Blood pressure > 140/80 mmHg
- Use of statin
- Use of tobacco
- Any other disease or condition that may prevent the practice of physical activity
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
São Paulo, 05403-010
About this study
Official title: Effectiveness and Feasibility of a Technology-supported Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis (THE_JIA Study): a Randomized Controlled Trial.
This study will aim to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescents (< 18 years) with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Participants will be supported by educational materials, a heart rate monitor, and through periodic contact with an exercise specialist via video and phone calls, and text messages. The study's primary outcomes will be: cardiac and vascular function and structure using ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. In addition to that, the feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be assessed.
Read the detailed description
Juvenile idiopathic arthritis (JIA) is the most common type of arthritis in children and adolescents under the age of 16. In addition to the articular features of the disease, JIA is also characterized by multiple comorbidities, including cardiovascular manifestations. Part of the health conditions observed in adolescents with JIA may be caused by a reduced practice of physical activity. Lack of physical activity in this disease has been attributed to generic and specific barriers, such as time constraints, low motivation, limited access to specialized exercise centers, lack of specific programs for JIA patients, among others. More recently, the COVID-19 pandemic has imposed additional challenges for the engagement in physical activity in populations with chronic disease, including patients with JIA. In this scenario, home-based exercise programs supported by technology have arisen as potentially effective alternatives to upregulate physical activity levels in adolescents with JIA, which needs to be further explored. Therefore, the aim of this study will be to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescent (< 18 years) patients with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Exercise intensity and duration will be low-to-moderate in the first 4 weeks, and will progressively increase during the program. Participants will be supported by educational materials, a heart rate monitor, and by means of periodic contact with an exercise specialist via video and phone calls, and text messages. Participants in the control group will receive usual care and general instructions about physical activity. The study's primary outcome will be the cardiac and vascular structure and function assessed by vascular ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. Secondary outcomes will include clinical aspects of the disease, blood parameters, physical activity and sedentary behavior, food consumption, health-related quality of life, blood pressure, and cardiac autonomic function. Feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be evaluated. The effects of the intervention on study outcomes will be assessed by a mixed model analysis (p < 0.05).
- Being tested
- Exercise
- Keywords
- physical activity, exercise, vascular function, endothelial function, feasibility, home-based exercise
- Medical subject headings
- Arthritis, Juvenile, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called physical activity
Participants will perform weight-bearing exercises for 12 weeks. The intervention will be delivered remotely through video calling with an exercise specialist.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants will be instructed to perform 3 sessions of weight-bearing exercise per week, for 12 weeks. Exercise intensity and duration will be low-to-moderate in the first 4 weeks, and will progressively increase during the program. Participants will be supported by educational materials, a heart rate monitor, and by means of periodic contact with an exercise specialist via video and phone calls, and text messages. Receives: Behavioral: Exercise |
| Usual care (control group) | No intervention | Participants in the control group will receive usual care and general instructions about physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Endothelial function will be assessed through the evaluation of brachial flow-mediated dilation using a vascular ultrasound.
Measured: Change from baseline to 12 weeks
Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)
Left ventricle diastolic and systolic diameters, interventricular septum, and left ventricular posterior wall in millimeters per meter squared will be assessed using standard echocardiography.
Measured: Change from baseline to 12 weeks
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.
Measured: Change from baseline to 12 weeks
Left ventricular mass index
The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.
Measured: Change from baseline to 12 weeks
Left ventricular diastolic function
Left ventricular diastolic function will be assessed using tissue Doppler-based measurements of transmitral E and A velocities in metre per second.
Measured: Change from baseline to 12 weeks
Myocardial deformation
Myocardial deformation in longitudinal, radial, and circumferential directions will be assessed using two-dimensional speckle-tracking (2DST) echocardiography and expressed as a percentage.
Measured: Change from baseline to 12 weeks
Body fat
Body fat in % will be assessed using dual-energy X-ray absorptiometry.
Measured: Change from baseline to 12 weeks
Lean mass
Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.
Measured: Change from baseline to 12 weeks
Bone mineral content
Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.
Measured: Change from baseline to 12 weeks
Aerobic fitness
Aerobic fitness will be assessed through a graded treadmill exercise test. VO2max will be assessed using a metabolic cart and expressed in millilitres per kilograms of body weight.
Measured: Change from baseline to 12 weeks
Vascular structure
Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
Measured: Change from baseline to 12 weeks
Feasibility of the intervention
Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.
Measured: Change from baseline to 12 weeks
Adherence to the intervention
The adherence to the intervention will be assessed using the data from the physical activity diaries and heart rate monitor and will be expressed as percentage of complete sessions.
Measured: Change from baseline to 12 weeks
Secondary outcomes (23)
Disease activity
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
Measured: Change from baseline to 12 weeks
Disease activity
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
Measured: Change from baseline to 24 weeks
Functional ability
The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).
Measured: Change from baseline to 12 weeks
Functional ability
The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).
Measured: Change from baseline to 24 weeks
Health-related quality of life
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
Measured: Change from baseline to 12 weeks
Health-related quality of life
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
Measured: Change from baseline to 24 weeks
Cardiometabolic blood markers
The following cardiometabolic markers from blood will be assessed after 12-h fasting: blood glucose and insulin, total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, and triglycerides. This data will be expressed in milligrams per deciliter.
Measured: Change from baseline to 12 weeks
C-reactive protein
C-reactive protein levels in the blood will be assessed after 12-h fasting and expressed as milligrams per litre.
Measured: Change from baseline to 12 weeks
Physical activity and sedentary behavior
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Measured: Change from baseline to 12 weeks
Physical activity and sedentary behavior
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Measured: Change from baseline to 24 weeks
Motivation to physical activity
Motivation to physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2).
Measured: Change from baseline to 12 weeks
Physical activity-related behavior
Physical activity-related behavior will be asseessed using the Stages of Change model.
Measured: Change from baseline to 12 weeks
Food consumption
Food consumption will be assessed through 24-hour food recalls, collected on three non-consecutive days (one weekend day).
Measured: Change from baseline to 12 weeks
Blood pressure
Blood pressure (arterial pressure) will be assessed non-invasively using a multi-parameter monitor.
Measured: Change from baseline to 12 weeks
Cardiac autonomic function
Cardiac autonomic function will be assessed through the analysis of heart rate variability, which will be recorded using a heart rate monitor.
Measured: Change from baseline to 12 weeks
Muscle strength
Muscle strength will be assessed by the one-repetition maximum test on the bench press and knee extension machines and will be expressed as kilograms.
Measured: Change from baseline to 12 weeks
Muscle strength
Muscle strength will be assessed by the one-repetition maximum test on the bench press and knee extension machines and will be expressed as kilograms.
Measured: Change from baseline to 24 weeks
Handgrip strength
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
Measured: Change from baseline to 12 weeks
Handgrip strength
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
Measured: Change from baseline to 24 weeks
Functional capacity - Timed-Stands
Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.
Measured: Change from baseline to 12 weeks
Functional capacity - Timed-Stands
Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.
Measured: Change from baseline to 24 weeks
Functional capacity - Timed Up-And-Go
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
Measured: Change from baseline to 12 weeks
Functional capacity - Timed Up-And-Go
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114343
- Sponsor's protocol ID
- THE_JIA study
- Acronym
- THE_JIA
- Status last verified
- Aug 2021
- First submitted
- 7 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Feasibility of a Technology-supported Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis (THE_JIA Study): a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05114343
- Acronym / sponsor ID
- THE_JIA / THE_JIA study
- Keywords
- physical activity, exercise, vascular function, endothelial function, feasibility, home-based exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 9 Nov 2021 (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.
This study will aim to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescents (< 18 years) with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Participants will be supported by educational materials, a heart rate monitor, and through periodic contact with an exercise specialist via video and phone calls, and text messages. The study's primary outcomes will be: cardiac and vascular function and structure using ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. In addition to that, the feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be assessed.
Detailed description
Juvenile idiopathic arthritis (JIA) is the most common type of arthritis in children and adolescents under the age of 16. In addition to the articular features of the disease, JIA is also characterized by multiple comorbidities, including cardiovascular manifestations. Part of the health conditions observed in adolescents with JIA may be caused by a reduced practice of physical activity. Lack of physical activity in this disease has been attributed to generic and specific barriers, such as time constraints, low motivation, limited access to specialized exercise centers, lack of specific programs for JIA patients, among others. More recently, the COVID-19 pandemic has imposed additional challenges for the engagement in physical activity in populations with chronic disease, including patients with JIA. In this scenario, home-based exercise programs supported by technology have arisen as potentially effective alternatives to upregulate physical activity levels in adolescents with JIA, which needs to be further explored. Therefore, the aim of this study will be to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescent (< 18 years) patients with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Exercise intensity and duration will be low-to-moderate in the first 4 weeks, and will progressively increase during the program. Participants will be supported by educational materials, a heart rate monitor, and by means of periodic contact with an exercise specialist via video and phone calls, and text messages. Participants in the control group will receive usual care and general instructions about physical activity. The study's primary outcome will be the cardiac and vascular structure and function assessed by vascular ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. Secondary outcomes will include clinical aspects of the disease, blood parameters, physical activity and sedentary behavior, food consumption, health-related quality of life, blood pressure, and cardiac autonomic function. Feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be evaluated. The effects of the intervention on study outcomes will be assessed by a mixed model analysis (p < 0.05).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseParticipants will be instructed to perform 3 sessions of weight-bearing exercise per week, for 12 weeks. Exercise intensity and duration will be low-to-moderate in the first 4 weeks, and will progressively increase during the program. Participants will be supported by educational materials, a heart rate monitor, and by means of periodic contact with an exercise specialist via video and phone calls, and text messages. |
| Usual care (control group) | No intervention | –Participants in the control group will receive usual care and general instructions about physical activity. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with polyarticular or oligoarticular subtypes of juvenile idiopathic arthritis.
Key exclusion criteria (6 listed)
- Cardiovascular, metabolic, pulmonary or renal diseases
- Untreat thyroid disease
- Blood pressure > 140/80 mmHg
- Use of statin
- Use of tobacco
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 |
|---|---|---|
| ExerciseAlso: physical activityParticipants will perform weight-bearing exercises for 12 weeks. The intervention will be delivered remotely through video calling with an exercise specialist. | Behavioural | Exercise group |
Primary outcome
Endothelial function
Time frame: Change from baseline to 12 weeks
Endothelial function will be assessed through the evaluation of brachial flow-mediated dilation using a vascular ultrasound.
Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)
Time frame: Change from baseline to 12 weeks
Left ventricle diastolic and systolic diameters, interventricular septum, and left ventricular posterior wall in millimeters per meter squared will be assessed using standard echocardiography.
Left ventricular ejection fraction (LVEF)
Time frame: Change from baseline to 12 weeks
Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.
Left ventricular mass index
Time frame: Change from baseline to 12 weeks
The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.
Left ventricular diastolic function
Time frame: Change from baseline to 12 weeks
Left ventricular diastolic function will be assessed using tissue Doppler-based measurements of transmitral E and A velocities in metre per second.
Myocardial deformation
Time frame: Change from baseline to 12 weeks
Myocardial deformation in longitudinal, radial, and circumferential directions will be assessed using two-dimensional speckle-tracking (2DST) echocardiography and expressed as a percentage.
Body fat
Time frame: Change from baseline to 12 weeks
Body fat in % will be assessed using dual-energy X-ray absorptiometry.
Lean mass
Time frame: Change from baseline to 12 weeks
Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.
Bone mineral content
Time frame: Change from baseline to 12 weeks
Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.
Aerobic fitness
Time frame: Change from baseline to 12 weeks
Aerobic fitness will be assessed through a graded treadmill exercise test. VO2max will be assessed using a metabolic cart and expressed in millilitres per kilograms of body weight.
Vascular structure
Time frame: Change from baseline to 12 weeks
Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
Feasibility of the intervention
Time frame: Change from baseline to 12 weeks
Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.
Adherence to the intervention
Time frame: Change from baseline to 12 weeks
The adherence to the intervention will be assessed using the data from the physical activity diaries and heart rate monitor and will be expressed as percentage of complete sessions.
23 secondary outcomes
Disease activity
Time frame: Change from baseline to 12 weeks
Disease activity
Time frame: Change from baseline to 24 weeks
Functional ability
Time frame: Change from baseline to 12 weeks
Functional ability
Time frame: Change from baseline to 24 weeks
Health-related quality of life
Time frame: Change from baseline to 12 weeks
Health-related quality of life
Time frame: Change from baseline to 24 weeks
Cardiometabolic blood markers
Time frame: Change from baseline to 12 weeks
C-reactive protein
Time frame: Change from baseline to 12 weeks
Physical activity and sedentary behavior
Time frame: Change from baseline to 12 weeks
Physical activity and sedentary behavior
Time frame: Change from baseline to 24 weeks
Motivation to physical activity
Time frame: Change from baseline to 12 weeks
Physical activity-related behavior
Time frame: Change from baseline to 12 weeks
Food consumption
Time frame: Change from baseline to 12 weeks
Blood pressure
Time frame: Change from baseline to 12 weeks
Cardiac autonomic function
Time frame: Change from baseline to 12 weeks
Muscle strength
Time frame: Change from baseline to 12 weeks
Muscle strength
Time frame: Change from baseline to 24 weeks
Handgrip strength
Time frame: Change from baseline to 12 weeks
Handgrip strength
Time frame: Change from baseline to 24 weeks
Functional capacity - Timed-Stands
Time frame: Change from baseline to 12 weeks
Functional capacity - Timed-Stands
Time frame: Change from baseline to 24 weeks
Functional capacity - Timed Up-And-Go
Time frame: Change from baseline to 12 weeks
Functional capacity - Timed Up-And-Go
Time frame: Change from baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Juvenile Idiopathic Arthritis and Juvenile Arthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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 Brazil. 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 Tiago Peçanha, PhD (+5511948243542, tiagopecanha@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: Change from baseline to 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.