Axial SpondyloarthritisNCT05006690
Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise in Individuals With Axial Spondyloarthritis
A study testing Clinical Pilates-Based Exercise Training in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Spondyloarthritis (SpA) refers to a group of rheumatic diseases that share common clinical, genetic and imaging features. They are divided into two: axial (axSpA) and peripheral. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis
- What is being tested?
- Clinical Pilates-Based Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2023to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with axial spondyloarthritis
- Between the ages of 18-65,
- Literate,
- Having sufficient smartphone/computer knowledge to participate in the study or having a relative who can help in this regard,
- Having a smart phone/computer and an active internet connection,
- Individuals who have not exercised regularly in at least the last 3 months will be included in the study.
Who cannot join
- Having a diagnosis of uncontrolled/clinically significant other disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
- Malignancies
- Having a history of previous surgery on the spine and extremities and therefore loss of function,
- Pregnant individuals,
- Continuing another rehabilitation program,
- Have other conditions that prevent exercise,
- A significant change in medication regimen occurs while the study is ongoing,
- Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: Comparison of the Effects of Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise Training in Individuals With Axial Spondyloarthritis
Spondyloarthritis (SpA) refers to a group of rheumatic diseases that share common clinical, genetic and imaging features. They are divided into two: axial (axSpA) and peripheral. In addition to the pain caused by sacroiliitis and spondylitis, which are the main complaints, patients often experience joint stiffness, fatigue, mood disturbances and various degrees of functional limitations, and the quality of life of individuals can be significantly affected. Although there is consensus about the positive effects of exercise in AxSpA, no exercise regimen has been shown to be superior to another. Another exercise model whose effectiveness has been researched in recent years is "clinical pilates exercises". It is a version of the Pilates exercises created by Joseph Pilates, modified by physiotherapists to emphasize the most valuable components in the diagnosis and management of injuries and to increase their safety. Clinical Pilates exercises are an exercise model based on spinal stabilization principles. In addition, it has the principles of awareness, balance, breathing, concentration, centering, control, efficiency, flow, sensitivity, isolation and harmony. There are many studies investigating the effects of these exercises in the field of rehabilitation and highlighting improvements in different diseases, including ankylosing spondylitis, which is considered the prototype of axSpA. No study has been found examining exercise training applied via telerehabilitation to individuals with AxSpA and its effects. The aim of this study is to compare the effects of telerehabilitation and face-to-face clinical pilates-based exercise training on individuals with axial spondyloarthritis. Volunteers who meet the inclusion criteria will be randomly divided into 'telerehabilitation training group' and 'face-to-face training group' using the sealed envelope method. The individualized rehabilitation program will be applied to each group for 1 hour, 3 days a week, for 8 weeks. Disease-specific performance measurements and patient-reported scales that evaluate patients' disease activity, functionality, mood, quality of life, fear-avoidance, levels and perceptions of the disease will be applied to individuals three times in total: at the beginning, after the 8-week rehabilitation program and 6 months after the second evaluation.
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis
- Being tested
- Clinical Pilates-Based Exercise Training
- Keywords
- spinal stabilization exercise, telerehabilitation, clinical pilates, Ankylosing spondylitis, Axial spondyloarthritis, biopsychosocial
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pilates-Based Exercise TrainingOther
Clinical Pilates-Based exercise training based on spinal stabilization aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Training Group | Experimental | In the telerehabilitation group, an individualized rehabilitation program according to the principles of clinical pilates exercises based on spinal stabilization will be applied via video conference, 3 days a week, 1 hour, online in real-time, accompanied by a physiotherapist, for 8 weeks.
In the first session, informative training about the disease (pathophysiology of axial spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. Receives: Other: Clinical Pilates-Based Exercise Training |
| Face-to-Face Training Group | Experimental | In the face-to-face training group, an individualized rehabilitation program according to the principles of clinical pilates exercises based on spinal stabilization will be applied in the clinic under the supervision of a physiotherapist for 1 hour, 3 days a week, for 8 weeks.
In the first session, informative training about the disease (pathophysiology of axial spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. Receives: Other: Clinical Pilates-Based Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Functional Level
Bath Ankylosing Spondylitis Functional Index (BASFI): The index consists of 10 questions in total. For each item, the patient marks the VAS consisting of a 100 mm line. The score range is 0-100. The Turkish version study was conducted by Karatepe et al. made by. A high score indicates a bad result.
Measured: 5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
Evaluation of Disease Activity
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): The index consists of 6 items questioning 5 symptoms in total. The response of each item is evaluated with the Visual Analog Scale (VAS). A total score of ≥ 4 indicates active disease. Turkish version study Akkoç et al. made by.
Measured: 3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
Secondary outcomes (11)
Evaluation of Spinal Mobility and Hip Function
Bath Ankylosing Spondylitis Metrology Index (BASMI): The index, which consists of five clinical measurements, namely cervical rotation, tragus-wall distance, lumbar lateral flexion, modified Schober's test, and intermalleolar distance, is accepted as the most valid method for evaluating the axial skeleton. The higher the BASMI score the more severe the patient's limitation of movement.
Measured: 10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
Evaluation of Quality of Life
Ankylosing spondylitis quality of life questionnaire (ASQoL): ASQoL, which is one of the most commonly used disease-specific scales to measure the quality of life in axspa, consists of 18 items and total score ranges from 0-18. A high score indicates bad quality of life. The Turkish version study was conducted by Duruoz et al. made by.
Measured: 1 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
Evaluation of Biopsychosocial Status
BETY-Biopsychosocial Questionnaire (BETY-BQ): Each of the questions in this scale, which consists of 30 different cognitive belief statements, is scored between 0-4. The total score ranges from 0 to 120. A high score indicates a poor biopsychosocial level. It is a scale developed by Ünal et al.
Measured: 10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
Evaluation of Depression and Anxiety Levels
Hospital Anxiety and Depression Scale (HADS):This scale consisting of 14 questions, odd-numbered questions question anxiety and even questions question depression. The options take values between 0-3, with a high score indicating a bad emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale. The Turkish version study was done by Aydemir et al.
Measured: 7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
Evaluation of Kinesiophobia
Tampa Kinesophobia Scale (TCS): It is a 17-question scale that evaluates injury avoidance and fear of movement, and Kori et al. developed by. The Turkish version is from Tunca-Yılmaz et al. Made by. Its scoring is scored with "1 = Strongly disagree, 4 = Strongly agree". The score is calculated by reversing items 4, 8, 12, and 16. The total score is between 17 and 68. It is understood that the higher the score, the higher the kinesophobia. A total score of more than 37 is considered to be a high degree of kinesophobia.
Measured: 5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
Evaluation of Illness Perception
Brief Illness Perception Scale (BIPQ): In this scale, which consists of 9 questions, each question evaluates a component of the perception of illness. The first eight questions take values between 0-10. A high score indicates an increased level of perception of the disease as worrisome. The total score ranges from 0 to 80. The ninth question is an open-ended question that questions the patient's opinion about the possible causes of the disease. Turkish validity and reliability study was done by Karataş et al.
Measured: 3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
Evaluation of Physical Performance
Ankylosing Spondylitis Performance Index (ASPI): Objective measurement of functional level ASPI consists of standardized performance tests of 3 items evaluated with patient feedback in the BASFI form: (1) picking up 6 pencils one by one by bending forward at the waist; (2) put on socks (3 repetitions); and (3) standing from supine position (3 repetitions). During tests, patients are allowed to use a chair or desk/table to sit or lean on. The time to complete a task is measured and recorded in seconds for each test. Additionally, for each test, test-related pain and effort are recorded with patient-reported scores (numerical rating scale (NRS) and Borg scale, respectively).
Measured: 10-15 minutes, through study completion, an average of 8 weeks, change from baseline physical performance at 8 weeks.
Evaluation of rib cage mobility: Chest Expansion Measurement
Chest expansion is an ASAS recommended assessment to measure rib cage mobility. The patient is asked to place his hands behind his head. Chest circumference is measured at the fourth intercostal space during maximal inspiration and maximal expiration. Two repetitions are made and the better value is recorded.
Measured: 2 minutes, through study completion, an average of 8 weeks, change from baseline chest expansion at 8 weeks.
Side Bridge Endurance Test: Evaluation of spinal stabilization
Side bridge tests are measured by recording the time in seconds in which the patient maintains the position in which he/she is lying on his/her side on the mat, extending both legs straight and lifting his hips off the mat with the support he receives from his elbows and feet. The test is terminated when the person cannot maintain this position. Both sides are measured and averaged.
Measured: Testing time depends on the patient, through study completion, an average of 8 weeks, change from baseline spinal stabilization at 8 weeks.
Exercise Self-Efficacy Scale (ESES): Assessment of exercise self-efficacy
The ESES scale, developed by Bandura (1997), consists of 18 items that question a person's beliefs about their competence in exercising. The participant scores his/her self-confidence between 0 and 100 for each item asked. The validity and reliability of the scale in Turkish was conducted by Bozkurt et al.
Measured: 5 minutes, through study completion, an average of 8 weeks, change from baseline self-efficacy at 8 weeks.
ASAS (Assessment of SpondyloArthritis International Society) Health Index (ASAS-HI): Evaluation of health and disability
The ASAS Health Index was developed by the International Society for the Assessment of SpondyloArthritis (ASAS) to assess the health of patients with all forms of spondyloarthritis (especially radiographic and non-radiographic axial SpA). It is a self-report survey and measures functionality and health in patients with 17 questions. It has Turkish validity and reliability.
Measured: 5 minutes, through study completion, an average of 8 weeks, change from baseline disability at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start18 Dec 2023
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Banu Karaca, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006690
- Sponsor's protocol ID
- KA-21035
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise Training in Individuals With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05006690
- Acronym / sponsor ID
- KA-21035
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis
- Keywords
- spinal stabilization exercise, telerehabilitation, clinical pilates, Ankylosing spondylitis, Axial spondyloarthritis, biopsychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 16 Aug 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.
Spondyloarthritis (SpA) refers to a group of rheumatic diseases that share common clinical, genetic and imaging features. They are divided into two: axial (axSpA) and peripheral. In addition to the pain caused by sacroiliitis and spondylitis, which are the main complaints, patients often experience joint stiffness, fatigue, mood disturbances and various degrees of functional limitations, and the quality of life of individuals can be significantly affected. Although there is consensus about the positive effects of exercise in AxSpA, no exercise regimen has been shown to be superior to another. Another exercise model whose effectiveness has been researched in recent years is "clinical pilates exercises". It is a version of the Pilates exercises created by Joseph Pilates, modified by physiotherapists to emphasize the most valuable components in the diagnosis and management of injuries and to increase their safety. Clinical Pilates exercises are an exercise model based on spinal stabilization principles. In addition, it has the principles of awareness, balance, breathing, concentration, centering, control, efficiency, flow, sensitivity, isolation and harmony. There are many studies investigating the effects of these exercises in the field of rehabilitation and highlighting improvements in different diseases, including ankylosing spondylitis, which is considered the prototype of axSpA. No study has been found examining exercise training applied via telerehabilitation to individuals with AxSpA and its effects. The aim of this study is to compare the effects of telerehabilitation and face-to-face clinical pilates-based exercise training on individuals with axial spondyloarthritis. Volunteers who meet the inclusion criteria will be randomly divided into 'telerehabilitation training group' and 'face-to-face training group' using the sealed envelope method. The individualized rehabilitation program will be applied to each group for 1 hour, 3 days a week, for 8 weeks. Disease-specific performance measurements and patient-reported scales that evaluate patients' disease activity, functionality, mood, quality of life, fear-avoidance, levels and perceptions of the disease will be applied to individuals three times in total: at the beginning, after the 8-week rehabilitation program and 6 months after the second evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Training Group | Experimental | Other: Clinical Pilates-Based Exercise TrainingIn the telerehabilitation group, an individualized rehabilitation program according to the principles of clinical pilates exercises based on spinal stabilization will be applied via video conference, 3 days a week, 1 hour, online in real-time, accompanied by a physiotherapist, for 8 weeks. In the first session, informative training about the disease (pathophysiology of axial spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. |
| Face-to-Face Training Group | Experimental | Other: Clinical Pilates-Based Exercise TrainingIn the face-to-face training group, an individualized rehabilitation program according to the principles of clinical pilates exercises based on spinal stabilization will be applied in the clinic under the supervision of a physiotherapist for 1 hour, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of axial spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with axial spondyloarthritis
- Between the ages of 18-65,
- Literate,
- Having sufficient smartphone/computer knowledge to participate in the study or having a relative who can help in this regard,
- Having a smart phone/computer and an active internet connection,
Key exclusion criteria (8 listed)
- Having a diagnosis of uncontrolled/clinically significant other disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
- Malignancies
- Having a history of previous surgery on the spine and extremities and therefore loss of function,
- Pregnant individuals,
- Continuing another rehabilitation program,
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 |
|---|---|---|
| Clinical Pilates-Based Exercise TrainingClinical Pilates-Based exercise training based on spinal stabilization aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine. | Other | Face-to-Face Training Group, Telerehabilitation Training Group |
Primary outcome
Evaluation of Functional Level
Time frame: 5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
Bath Ankylosing Spondylitis Functional Index (BASFI): The index consists of 10 questions in total. For each item, the patient marks the VAS consisting of a 100 mm line. The score range is 0-100. The Turkish version study was conducted by Karatepe et al. made by. A high score indicates a bad result.
Evaluation of Disease Activity
Time frame: 3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): The index consists of 6 items questioning 5 symptoms in total. The response of each item is evaluated with the Visual Analog Scale (VAS). A total score of ≥ 4 indicates active disease. Turkish version study Akkoç et al. made by.
11 secondary outcomes
Evaluation of Spinal Mobility and Hip Function
Time frame: 10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
Evaluation of Quality of Life
Time frame: 1 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
Evaluation of Biopsychosocial Status
Time frame: 10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
Evaluation of Depression and Anxiety Levels
Time frame: 7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
Evaluation of Kinesiophobia
Time frame: 5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
Evaluation of Illness Perception
Time frame: 3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
Evaluation of Physical Performance
Time frame: 10-15 minutes, through study completion, an average of 8 weeks, change from baseline physical performance at 8 weeks.
Evaluation of rib cage mobility: Chest Expansion Measurement
Time frame: 2 minutes, through study completion, an average of 8 weeks, change from baseline chest expansion at 8 weeks.
Side Bridge Endurance Test: Evaluation of spinal stabilization
Time frame: Testing time depends on the patient, through study completion, an average of 8 weeks, change from baseline spinal stabilization at 8 weeks.
Exercise Self-Efficacy Scale (ESES): Assessment of exercise self-efficacy
Time frame: 5 minutes, through study completion, an average of 8 weeks, change from baseline self-efficacy at 8 weeks.
ASAS (Assessment of SpondyloArthritis International Society) Health Index (ASAS-HI): Evaluation of health and disability
Time frame: 5 minutes, through study completion, an average of 8 weeks, change from baseline disability at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pilates-Based Exercise Training in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Evaluation of Functional Level (time frame: 5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.). 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?
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 24 Aug 2025.