SpondylarthritisASPIRENCT07034404
Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis
A study testing Digital Adapted Physical Activity in people with Spondylarthritis and Spondylarthropathies; Spondylitis, Ankylosing, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The goal of this clinical trial is to assess whether a tailored digital Adapted Physical Activity (APA) program can improve physical activity levels and sleep quality in adults diagnosed with spondyloarthritis (SpA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondylarthritis, Spondylarthropathies; Spondylitis, Ankylosing
- What is being tested?
- Digital Adapted Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jul 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80
- Followed in rheumatology for axial spondyloarthritis validating the ASAS or modified New York criteria at all stages of progression,
- Physically inactive (less than 150 minutes of moderate-intensity leisure-time physical activity per week), assessed at inclusion using the Global Physical Activity Questionnaire (GPAQ).
- With stable treatment for 3 months
- Signed informed consent
- Membership of a social security scheme
- Have access to a digital tool with an internet connection (tablet or smartphone)
Who cannot join
- Concurrent impairment by another osteoarticular pathology interfering with mobility of the spine or lower limbs,
- Central or peripheral neurological damage,
- Hip, knee or ankle arthroplasty performed or scheduled within 18 months,
- Any contraindication to physical activity (unstable or poorly controlled coronary ischaemia, severe asthma or significant obstructive ventilatory disorder (FEV1/FVC < 70%, FEV1 < 60% predicted), musculoskeletal pathology interfering with physical activity, proliferative retinopathy, macroscopic proteinuria, poorly controlled hypertension, etc.).
- Patients who do more than 150 minutes of moderate-intensity vigorous physical activity per week as part of their leisure activities.
- Persons covered by articles L1121-5 to L1121-8 of the Public Health Code
Show all 12Show fewer
- Staff with a hierarchical link to the principal investigator
- Non-inclusion criteria related to physical activity :
- Body mass index >35 kg/m2
- History of chest pain during physical activity
- History of sudden death in a first-degree relative
- History of thoracic irradiation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
CHU de Bordeaux
Bordeaux
Thierry Schaeverbeke Professor, MD PhD, 33-5 56 79 55 45, AccueilRecherche@chu-bordeaux.fr
CHU Clermont Ferrand
Clermont-Ferrand
Anne Tournadre Professor, MD PhD, 33-4 73 75 07 50, AccueilRecherche@chu-clermontferrand.fr
CHU Saint Etienne
Saint-Etienne
Hubert Marotte Professor, MD PhD, 33-04 77 82 80 00, AccueilRecherche@chu-st-etienne.fr
About this study
Official title: Effects of a Digital Adapted Physical Activity Program on Physical Activity Levels and Sleep Quality in Patients With Spondyloarthritis: A Randomized, Controlled, Multicenter Study.
The goal of this clinical trial is to assess whether a tailored digital Adapted Physical Activity (APA) program can improve physical activity levels and sleep quality in adults diagnosed with spondyloarthritis (SpA).
The main questions it aims to answer are:
Read more
Does participation in a 6-month digital APA program increase average daily step count (measured with an activity tracker)? Does the program improve sleep quality (measured with the Pittsburgh Sleep Quality Index)? Researchers will compare participants receiving general physical activity advice (control group) to those following a structured digital APA program (intervention group) to see if the tailored digital support leads to better outcomes.
Participants will:
Complete baseline assessments including physical activity, sleep, pain, and quality of life measures.
Be randomly assigned to a control group or intervention group. For the intervention group, follow an individualized exercise program delivered through a virtual platform with support from an APA professional over 10 virtual sessions.
Wear a connected activity tracker (Withings) to monitor physical activity throughout the study.
Complete follow-up assessments at 6 and 12 months.
- Being tested
- Digital Adapted Physical Activity, Control (Standard treatment)
- Keywords
- exercise, physical activity, sleep quality, digital intervention
- Medical subject headings
- Spondylarthritis, Spondylarthropathies, Spondylitis, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Adapted Physical ActivityBehavioural
The digital Adapted Physical Activity (APA) program will be delivered via a digital platform and participants will be guided by an APA teacher to meet the WHO recommendations (i.e. 150 minutes of moderate intensity aerobic PA per week and muscle-strengthening activities that involve all major muscle groups twice weekly).
Participants will benefit from 10 visits with the APA teacher: an initial assessment to define personalized goals and familiarize participants with the digital platform, eight sessions to monitor progress and adapt the exercise program, and a final evaluation aimed at assessing outcomes and encouraging long-term adherence to physical activity. Daily physical activity will be objectively monitored using a Withings connected watch to provide feedback and track metrics such as step count.
Control (Standard treatment)Behavioural
Participants will receive standard care and advice on physical activity (based on the recommendations of the World Health Organization, WHO, and the European Alliance of Associations for Rheumatology, EULAR) through a document provided to them.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Behavioral: Control (Standard treatment) |
| Digital Adapted Physical Activity | Experimental | Not described Receives: Behavioral: Digital Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Steps Per Day at 6 months
Measured by Actigraph GT3X
Measured: Baseline and 6 months
Change from Baseline in Sleep Quality at 6 months
Measured by the Pittsburgh Sleep Quality Index (PSQI) / A self-administered questionnaire / The 19 self-evaluation questions combine to yield 7 component scores, each scored from 0 to 3. A score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 component scores are summed to obtain a global score ranging from 0 (no difficulty) to 21 (major difficulties).
Measured: Baseline and 6 months
Secondary outcomes (23)
Change in Steps Per Day from Baseline at 12 months
Measured by Actigraph (GT3X)
Measured: Baseline and 12 months
Change in Sleep Quality from Baseline at 12 months
Measured by the Pittsburgh Sleep Quality Index (PSQI) / A self-administered questionnaire / The 19 self-evaluation questions combine to yield 7 component scores, each scored from 0 to 3. A score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 component scores are summed to obtain a global score ranging from 0 (no difficulty) to 21 (major difficulties).
Measured: Baseline and 12 months
Change from Baseline in Total Sleep Time at 6 and 12 months
Measured using wrist-worn actigraphy (Actigraph GT3X)
Measured: Baseline, 6 months and 12 months
Change from Baseline in Time Spent in Physical Activity at 6 and 12 months
Measured by time spent in light, moderate and sustained physical activity
Measured: Baseline, 6 months and 12 months
Change from Baseline in Time Spent in Sedentary Behavior at 6 and 12 months
Measured by time spent awake in a seated or lying position measured by actimeter (Actigraph GT3X)
Measured: Baseline, 6 months and 12 months
Change from Baseline in Sleep Quality at 6 and 12 months
Measured using wrist-worn actigraphy (Actigraph GT3X)
Measured: Baseline, 6 months and 12 months
Change from Baseline in Fatigue at 6 and 12 months
Measured by the Pichot fatigue scale / Likert scale / This scale includes 8 items scored from 0 (strongly disagree) to 4 (strongly agree), with a total score ranging from 0 (no fatigue) to 32 (maximum fatigue)
Measured: Baseline, 6 months and 12 months
Change from Baseline in Pain at 6 and 12 months
Measured by the visual analogue scale / Visual Analog Scale (VAS) / This scale consists of 1 item scored from 0 (no pain) to 10 (extreme pain)
Measured: Baseline, 6 months and 12 months
Change from baseline in Disease Activity BASDAI to 6 and 12 months
Measured using questionnaires Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) / Self-administered scale / This scale consists of 6 items assessed on a numerical rating scale from 0 (not at all) to 10 (extremely). The overall score is the average of the six responses, giving a total score between 0 (no symptoms) and 10 (maximum symptoms).
Measured: Baseline, 6 months and 12 months
Change from Baseline in Disease Activity ASDAS at 6 and 12 months
Measured using questionnaires Ankylosing Spondylitis Disease Activity Score (ASDAS) / A composite index combining several clinical variables and a biological marker of inflammation. The final score is calculated using a weighted formula, resulting in a continuous score / ASDAS values generally range from 0 to over 6, with the following thresholds:
- < 1.3: Inactive disease
- 1.3 to < 2.1: Moderate disease activity
- 2.1 to < 3.5: High disease activity
- ≥ 3.5: Very high disease activity
Measured: Baseline, 6 months and 12 months
Change from Baseline in Functional Capacity at 6 and 12 months
Measured using questionnaires an Bath Ankylosing Spondylitis Functional Index (BASFI) / Self-administered questionnaire / This questionnaire consists of 10 items. Each item is scored on a numerical rating scale from 0 (no difficulty) to 10 (impossible). The final score is the average of the 10 responses, giving a total score between 0 (optimal functioning) and 10 (severely impaired functioning).
Measured: Baseline, 6 months and 12 months
Change from Baseline in Quality of life ASAS-HI at 6 and 12 months
Measured using questionnaire ASAS-HI (Assessment of SpondyloArthritis International Society Health Index) / Likert-type scale / A questionnaire composed of 17 items. Each item is scored in a binary way (Agree = 1, Disagree = 0). The total score therefore ranges from 0 (best possible health) to 17 (significant health impairment).
Measured: Baseline, 6 months and 12 months
Change from Baseline in Health-Related Quality of life at 6 and 12 months
Health-related quality of life (EQ-5D-5L) / 2 parts:
- A descriptive system with 5 dimensions, each rated on 5 levels of severity (from 1 = no problems to 5 = extreme problems). The combination of responses defines a health state that can be converted into a single index value, generally ranging from -0.594 to 1, where 1 represents perfect health, 0 is equivalent to death, and negative values indicate a health state perceived as worse than death.
- A visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: Baseline, 6 months and 12 months
Change from Baseline in Cardiorespiratory fitness (VO2peak) at 6 months
Cardiorespiratory stress test
Measured: Baseline, 6 months
Change from Baseline in Maximal Power Output at 6 months
Maximal Power Output (watts)
Measured: Baseline, 6 months
Change from Baseline in Barriers and Facilitators to Physical Activity at 3, 6 and 12 months
Measured using questionnaire Inflammatory Arthritis Facilitators and Barriers (IFAB) / A questionnaire consisting of 10 items / Elements that can be either barriers or facilitators are scored from -10 to 10. Items that are only barriers are scored from -10 to 0, and those that are only facilitators are scored from 0 to 10. When an item has no impact on physical activity, it is scored 0. If a question is missing, the item is scored 0. If two or more questions are missing, it is recommended not to compute the total score. The total score ranges from -70 to 70. Scores below -5 may justify targeted intervention.
Measured: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Motivation for Physical Activity at 3, 6 and 12 months
Measured using questionnaire motivational scale for physical activity for health purposes (EMAPS) / Questionnaire based on the self-determination theory / Composed of 18 items. Each item is scored on a 7-point Likert scale from 1 (does not correspond at all) to 7 (corresponds very strongly). Mean scores are calculated for each subscale / The questionnaire represents the following types of motivation:
- Intrinsic motivation
- Integrated motivation
- Identified motivation
- Introjected motivation
- External motivation
- Amotivation
Measured: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Self-Esteem at 3, 6 and 12 months
Measured using questionnaire Rosenberg scale / A self-assessment questionnaire composed of 10 items / Each item is rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 10 to 40, with some items reverse-scored.
Measured: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Pain Catastrophizing at 3, 6, 12 months
Pain Castrophizing Scale / A self-administered questionnaire / It includes 13 items divided into 3 dimensions:
- Rumination
- Magnification
- Helplessness / Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 52, with subscores for each dimension
Measured: Baseline, 3, 6, 12 months
Adherence to the Adapted Physical Activity Intervention
Percentage of Physical Activity Sessions Completed by the Participant
Measured: At 6 months
Identify profiles of participants who are adherent or non- adherent to the Physical Activity Intervention according to personal determinants (motivation, beliefs)
Adherent or non-adherent (adherence status defined as < 50% sessions completed)
Measured: At 6 months
Determine Sleep Quality Trajectories
Determine sleep quality trajectories based on data collected by the connected device (Sleel Analyzer, Withings) in the intervention group only
Measured: Over 12 months
Intervention Satisfaction and Acceptability
Perceived acceptability and satisfaction measured using a questionnaire in the intervention group
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034404
- Sponsor's protocol ID
- EssaiClinique_ASPIRE
- Acronym
- ASPIRE
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Digital Adapted Physical Activity Program on Physical Activity Levels and Sleep Quality in Patients With Spondyloarthritis: A Randomized, Controlled, Multicenter Study.
- ClinicalTrials.gov ID
- NCT07034404
- Acronym / sponsor ID
- ASPIRE / EssaiClinique_ASPIRE
- Keywords
- exercise, physical activity, sleep quality, digital intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Jun 2025 (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 goal of this clinical trial is to assess whether a tailored digital Adapted Physical Activity (APA) program can improve physical activity levels and sleep quality in adults diagnosed with spondyloarthritis (SpA).
The main questions it aims to answer are:
Does participation in a 6-month digital APA program increase average daily step count (measured with an activity tracker)? Does the program improve sleep quality (measured with the Pittsburgh Sleep Quality Index)? Researchers will compare participants receiving general physical activity advice (control group) to those following a structured digital APA program (intervention group) to see if the tailored digital support leads to better outcomes.
Participants will:
Complete baseline assessments including physical activity, sleep, pain, and quality of life measures.
Be randomly assigned to a control group or intervention group. For the intervention group, follow an individualized exercise program delivered through a virtual platform with support from an APA professional over 10 virtual sessions.
Wear a connected activity tracker (Withings) to monitor physical activity throughout the study.
Complete follow-up assessments at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control (Standard treatment) |
| Digital Adapted Physical Activity | Experimental | Behavioral: Digital Adapted Physical Activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 80
- Followed in rheumatology for axial spondyloarthritis validating the ASAS or modified New York criteria at all stages of progression,
- Physically inactive (less than 150 minutes of moderate-intensity leisure-time physical activity per week), assessed at inclusion using the Global Physical Activity Questionnaire (GPAQ).
- With stable treatment for 3 months
- Signed informed consent
Key exclusion criteria (12 listed)
- Concurrent impairment by another osteoarticular pathology interfering with mobility of the spine or lower limbs,
- Central or peripheral neurological damage,
- Hip, knee or ankle arthroplasty performed or scheduled within 18 months,
- Any contraindication to physical activity (unstable or poorly controlled coronary ischaemia, severe asthma or significant obstructive ventilatory disorder (FEV1/FVC < 70%, FEV1 < 60% predicted), musculoskeletal pathology interfering with physical activity, proliferative retinopathy, macroscopic proteinuria, poorly controlled hypertension, etc.).
- Patients who do more than 150 minutes of moderate-intensity vigorous physical activity per week as part of their leisure activities.
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 |
|---|---|---|
| Digital Adapted Physical ActivityThe digital Adapted Physical Activity (APA) program will be delivered via a digital platform and participants will be guided by an APA teacher to meet the WHO recommendations (i.e. 150 minutes of moderate intensity aerobic PA per week and muscle-strengthening activities that involve all major muscle groups twice weekly). Participants will benefit from 10 visits with the APA teacher: an initial assessment to define personalized goals and familiarize participants with the digital platform, eight sessions to monitor progress and adapt the exercise program, and a final evaluation aimed at assessing outcomes and encouraging long-term adherence to physical activity. Daily physical activity will be objectively monitored using a Withings connected watch to provide feedback and track metrics such as step count. | Behavioural | Digital Adapted Physical Activity |
| Control (Standard treatment)Participants will receive standard care and advice on physical activity (based on the recommendations of the World Health Organization, WHO, and the European Alliance of Associations for Rheumatology, EULAR) through a document provided to them. | Behavioural | Control |
Primary outcome
Change from Baseline in Steps Per Day at 6 months
Time frame: Baseline and 6 months
Measured by Actigraph GT3X
Change from Baseline in Sleep Quality at 6 months
Time frame: Baseline and 6 months
Measured by the Pittsburgh Sleep Quality Index (PSQI) / A self-administered questionnaire / The 19 self-evaluation questions combine to yield 7 component scores, each scored from 0 to 3. A score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 component scores are summed to obtain a global score ranging from 0 (no difficulty) to 21 (major difficulties).
23 secondary outcomes
Change in Steps Per Day from Baseline at 12 months
Time frame: Baseline and 12 months
Change in Sleep Quality from Baseline at 12 months
Time frame: Baseline and 12 months
Change from Baseline in Total Sleep Time at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Time Spent in Physical Activity at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Time Spent in Sedentary Behavior at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Sleep Quality at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Fatigue at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Pain at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from baseline in Disease Activity BASDAI to 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Disease Activity ASDAS at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Functional Capacity at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Quality of life ASAS-HI at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Health-Related Quality of life at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Cardiorespiratory fitness (VO2peak) at 6 months
Time frame: Baseline, 6 months
Change from Baseline in Maximal Power Output at 6 months
Time frame: Baseline, 6 months
Change from Baseline in Barriers and Facilitators to Physical Activity at 3, 6 and 12 months
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Motivation for Physical Activity at 3, 6 and 12 months
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Self-Esteem at 3, 6 and 12 months
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Pain Catastrophizing at 3, 6, 12 months
Time frame: Baseline, 3, 6, 12 months
Adherence to the Adapted Physical Activity Intervention
Time frame: At 6 months
Identify profiles of participants who are adherent or non- adherent to the Physical Activity Intervention according to personal determinants (motivation, beliefs)
Time frame: At 6 months
Determine Sleep Quality Trajectories
Time frame: Over 12 months
Intervention Satisfaction and Acceptability
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Adapted Physical Activity in people with Spondylarthritis and Spondylarthropathies; Spondylitis, Ankylosing, run by University Hospital, Grenoble at 3 sites in France.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athan Baillet Professor, MD PhD (+33-0476768082, AccueilRecherche@chu-grenoble.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Steps Per Day at 6 months (time frame: Baseline and 6 months). 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 29 Jun 2025.