Mobility LimitationsFITWITHUSNCT06207084
The Fit With Us Study
A study testing asynchronous content only, Asynchronous content and health coaching and no live training and asynchronous content only and 1 on 1 live training in people with Mobility Limitations and Disability Physical, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Mobility Limitations, Disability Physical, Telehealth
- What is being tested?
- asynchronous content only, Asynchronous content and health coaching and no live training and asynchronous content only and 1 on 1 live training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Feb 2029
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligible participants must meet the following criteria to be included: (1) live with a permanent physical disability that limits their mobility; (2) be 18 to 89 years of age; (3) have broadband internet access; (4) be able to speak and read English; and (5) be able to attend coaching and training sessions during the weekdays.
Participants are excluded from participation if they (1) possess significant visual acuity that prevents seeing a computer screen to follow a home exercise program; (2) have been regularly engaging in exercise for the previous 3 months; (3) are unable to use their arms and their legs at all to exercise; (4) are unsafe to exercise; (5) self-report that they are currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wellness, Health and Research Facility
Birmingham, Alabama, 35209
Ayse G Zengul, PhD, 659 2733627, aysezen@uab.edu
Mohanraj Thirumalai, PhD
About this study
Official title: Precision-based Teleexercise Trial to Increase Adherence in People With Disabilities
The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.
Read the detailed description
The proposed Sequential Multiple Assignment Randomized Trial (SMART) study seeks to develop an effective 32-week, resource sensitive strategy to improve physical activity levels in people with mobility impairments.
During the run-In period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, Participants will respond to a baseline survey packet through REDCap. Participants must also complete a welcome call and set up an online account. Additionally, during the run-in period, the research team will ship an exercise tracker device, and an exercise band for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. (see attached call outline)
After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles). All participants will receive at least one new health and wellness article per week for eight weeks, and new exercise videos for 16 weeks.
The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 12 health coaching calls. Machine learning will be used in Weeks 2, 6, and 10 to predict which AEP + HC participants should receive coaching calls for the next four weeks.
The proposed Sequential Multiple Assignment Randomized Trial (SMART) study seeks to develop an effective 32-week, resource-sensitive strategy to improve physical activity levels in people with mobility impairments. During the run-in period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, participants will respond to a baseline survey packet through REDCap. Participants must also complete a welcome call and set up an online account. Additionally, during the run-in period, the research team will ship an exercise tracker device, and an exercise band for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles). All participants will receive at least one new health and wellness article per week for eight weeks, and new exercise videos for 16 weeks. This intervention will be administered in 8 waves of ~33-34 participants each (pilot wave data excluded from analyses). The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 12 health coaching calls. Machine learning will be used in Weeks 2, 6, and 10 to predict which AEP + HC participants should receive coaching calls for the next four weeks. At the end of the early adoption phase, the participant will complete a short set of questions (See week 4 questionnaire) the research team will classify participants in both groups into either a responder or a non-responder. If a participant is a responder, they will continue with their group assignment through the late adoption phase (AEP only or AEP + SHC). If the participant is a non-responder, they will be randomized a second time into 1 of 2 sub-groups: Live 1-on-1 training or Live group training for the late adoption phase. All live training will occur remotely through ZOOM. Participants in non-responder sub-groups will be asked to participate in their respective live training up to 3 times per week for weeks 5 to 8. This second randomization results in six possible intervention groups: 1) AEP only responder, 2) AEP + HC responder, 3) AEP non-responder + LAT_1-1, 4) AEP non-responder + LAT_GRP, 5) AEP + HC non-responder + LAT_1-1, 6) AEP + HC non-responder + LAT_GRP. Upon finishing the late adoption phase, all participants will complete another survey packet and a semi-structured interview (see interview guide), and receive AEP only for a 24-week maintenance phase (weeks 9-32). Upon completion of week 32, the participant will complete a final survey packet. Throughout the study, we will be collecting data from the participant's exercise tracker. These data include steps and minutes of activity/inactivity. During weeks 9 to 32, participants will have open access to the website and its library of exercise content. The research team will continue to collect activity data and website analytics (for example video watch minutes). Participants may receive a reminder call to complete surveys. We will use the following validated measures: [existing measures list unchanged].
- Conditions
- Mobility Limitations, Disability Physical, Telehealth, Health Coaching, Physical Activity, Behavior, Health
- Being tested
- asynchronous content only, Asynchronous content and health coaching and no live training, asynchronous content only and 1 on 1 live training, asynchronous content and health coaching and 1 on 1 training, asynchronous content and group training
- Keywords
- telehealth, health coaching, disability
- Medical subject headings
- Mobility Limitation, Motor Activity, Health Behavior, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asynchronous content onlyBehavioural
Receives asynchronous exercise content and no live training
Asynchronous content and health coaching and no live trainingBehavioural
Receives asynchronous content, health coaching and no live training.
asynchronous content only and 1 on 1 live trainingBehavioural
receives asynchronous content and live 1 on 1 training
asynchronous content and health coaching and 1 on 1 trainingBehavioural
receives asynchronous content, health coaching, and live training
asynchronous content and group trainingBehavioural
receives asynchronous content and live group training
Asynchronous content and health coaching and group trainingBehavioural
receives asynchronous content, health coaching, and live group training
| Study group | Role | What they receive |
|---|---|---|
| asynchronous exercise responder | Experimental | Individuals only receiving asynchronous exercise content and are responding Receives: Behavioral: asynchronous content only |
| Asynchronous exercise and health coaching responder | Experimental | Individuals receiving asynchronous exercise content and health coaching and are responding Receives: Behavioral: Asynchronous content and health coaching and no live training |
| Asynchronous exercise non-responder and 1 on 1 live training | Experimental | Individuals receiving asynchronous exercise content and are not responding. The are receiving 1 on 1 live exercise sessions. Receives: Behavioral: asynchronous content only and 1 on 1 live training |
| Asynchronous exercise and health coaching non-responder and 1 on 1 live training | Experimental | Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving 1 on 1 live exercise sessions. Receives: Behavioral: asynchronous content and health coaching and 1 on 1 training |
| Asynchronous exercise non-responder and group live training | Experimental | Individuals receiving asynchronous exercise content and are not responding. The are receiving group live exercise sessions. Receives: Behavioral: asynchronous content and group training |
| Asynchronous exercise and health coaching non-responder and group live training | Experimental | Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving group live exercise sessions. Receives: Behavioral: Asynchronous content and health coaching and group training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
The primary outcome is the change in physical activity (steps per day) from baseline to the end of the 32-week intervention.
Participants wear Fitbit Inspire 3 trackers (Google LLC, Sacramento, CA) for continuous objective measurement, with data exported via the study dashboard.
This is supplemented by the Godin Leisure-Time Exercise Questionnaire (GLETQ) at baseline, week-8 and week-16 for self-reported leisure-time activity in MET-minutes/week.
Measured: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32
Secondary outcomes (3)
Health information technology literacy
The secondary outcome is health information technology literacy, measured by the eHealth Literacy Scale (eHEALS).
The eHEALS is a validated 8-item questionnaire assessing participants' perceived skills in finding, evaluating, and applying online health information (scored 8-40).
Assessments occur at baseline, week 8, week 16, and week 32 to track changes over the 32-week intervention.
Measured: Baseline, week 8, week 16, and week 32
Secondary Health Conditions
The secondary outcome is secondary health conditions, assessed via National Institutes of Health Patient-Reported Outcome Measurement Information System (PROMIS) questionnaires.
PROMIS measures include pain interference, fatigue, sleep disturbance, and quality of life, each on a T-score metric (mean 50, SD 10) for standardized comparison.
Assessments occur at baseline, week 8, week 16, and week 32 to evaluate changes over the 32-week intervention.
Measured: Baseline, week 8, week 16, and week 32
Activity limitations
The secondary outcome is activity limitations, measured by the Physical Functioning subscale of the 36-Item Short Form Survey (SF-36 PF).
The SF-36 PF is a validated 10-item questionnaire assessing limitations in physical activities due to health problems (scored 0-100, higher scores indicate better functioning).
Assessments occur at baseline, week 8, week 16, and week 32 to track changes over the 32-week intervention.
Measured: Baseline, week 8, week 16, and week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Sep 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Sequential Multiple Assignment Randomization Model
- Masking
- None (open label)
- Enrolment
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanraj Thirumalai, University of Alabama at Birmingham
- Investigators
- Mohanraj Thirumalai, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207084
- Sponsor's protocol ID
- IRB-300011762
- Other IDs
- 90REGE0019
- Acronym
- FITWITHUS
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2024
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision-based Teleexercise Trial to Increase Adherence in People With Disabilities
- ClinicalTrials.gov ID
- NCT06207084
- Acronym / sponsor ID
- FITWITHUS / IRB-300011762
- Conditions
- Mobility Limitations, Disability Physical, Telehealth, Health Coaching, Physical Activity, Behavior, Health
- Keywords
- telehealth, health coaching, disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 16 Jan 2024 (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 purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.
Detailed description
The proposed Sequential Multiple Assignment Randomized Trial (SMART) study seeks to develop an effective 32-week, resource sensitive strategy to improve physical activity levels in people with mobility impairments.
During the run-In period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, Participants will respond to a baseline survey packet through REDCap. Participants must also complete a welcome call and set up an online account. Additionally, during the run-in period, the research team will ship an exercise tracker device, and an exercise band for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. (see attached call outline)
After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles). All participants will receive at least one new health and wellness article per week for eight weeks, and new exercise videos for 16 weeks.
The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 12 health coaching calls. Machine learning will be used in Weeks 2, 6, and 10 to predict which AEP + HC participants should receive coaching calls for the next four weeks.
The proposed Sequential Multiple Assignment Randomized Trial (SMART) study seeks to develop an effective 32-week, resource-sensitive strategy to improve physical activity levels in people with mobility impairments. During the run-in period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, participants will respond to a baseline survey packet through REDCap. Participants must also complete a welcome call and set up an online account. Additionally, during the run-in period, the research team will ship an exercise tracker device, and an exercise band for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles). All participants will receive at least one new health and wellness article per week for eight weeks, and new exercise videos for 16 weeks. This intervention will be administered in 8 waves of ~33-34 participants each (pilot wave data excluded from analyses). The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 12 health coaching calls. Machine learning will be used in Weeks 2, 6, and 10 to predict which AEP + HC participants should receive coaching calls for the next four weeks. At the end of the early adoption phase, the participant will complete a short set of questions (See week 4 questionnaire) the research team will classify participants in both groups into either a responder or a non-responder. If a participant is a responder, they will continue with their group assignment through the late adoption phase (AEP only or AEP + SHC). If the participant is a non-responder, they will be randomized a second time into 1 of 2 sub-groups: Live 1-on-1 training or Live group training for the late adoption phase. All live training will occur remotely through ZOOM. Participants in non-responder sub-groups will be asked to participate in their respective live training up to 3 times per week for weeks 5 to 8. This second randomization results in six possible intervention groups: 1) AEP only responder, 2) AEP + HC responder, 3) AEP non-responder + LAT_1-1, 4) AEP non-responder + LAT_GRP, 5) AEP + HC non-responder + LAT_1-1, 6) AEP + HC non-responder + LAT_GRP. Upon finishing the late adoption phase, all participants will complete another survey packet and a semi-structured interview (see interview guide), and receive AEP only for a 24-week maintenance phase (weeks 9-32). Upon completion of week 32, the participant will complete a final survey packet. Throughout the study, we will be collecting data from the participant's exercise tracker. These data include steps and minutes of activity/inactivity. During weeks 9 to 32, participants will have open access to the website and its library of exercise content. The research team will continue to collect activity data and website analytics (for example video watch minutes). Participants may receive a reminder call to complete surveys. We will use the following validated measures: [existing measures list unchanged].
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sequential Multiple Assignment Randomization Model
| Arm | Type | Receives |
|---|---|---|
| asynchronous exercise responder | Experimental | Behavioral: asynchronous content onlyIndividuals only receiving asynchronous exercise content and are responding |
| Asynchronous exercise and health coaching responder | Experimental | Behavioral: Asynchronous content and health coaching and no live trainingIndividuals receiving asynchronous exercise content and health coaching and are responding |
| Asynchronous exercise non-responder and 1 on 1 live training | Experimental | Behavioral: asynchronous content only and 1 on 1 live trainingIndividuals receiving asynchronous exercise content and are not responding. The are receiving 1 on 1 live exercise sessions. |
| Asynchronous exercise and health coaching non-responder and 1 on 1 live training | Experimental | Behavioral: asynchronous content and health coaching and 1 on 1 trainingIndividuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving 1 on 1 live exercise sessions. |
| Asynchronous exercise non-responder and group live training | Experimental | Behavioral: asynchronous content and group trainingIndividuals receiving asynchronous exercise content and are not responding. The are receiving group live exercise sessions. |
| Asynchronous exercise and health coaching non-responder and group live training | Experimental | Behavioral: Asynchronous content and health coaching and group trainingIndividuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving group live exercise sessions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| asynchronous content onlyReceives asynchronous exercise content and no live training | Behavioural | asynchronous exercise responder |
| Asynchronous content and health coaching and no live trainingReceives asynchronous content, health coaching and no live training. | Behavioural | Asynchronous exercise and health coaching responder |
| asynchronous content only and 1 on 1 live trainingreceives asynchronous content and live 1 on 1 training | Behavioural | Asynchronous exercise non-responder and 1 on 1 live training |
| asynchronous content and health coaching and 1 on 1 trainingreceives asynchronous content, health coaching, and live training | Behavioural | Asynchronous exercise and health coaching non-responder and 1 on 1 live training |
| asynchronous content and group trainingreceives asynchronous content and live group training | Behavioural | Asynchronous exercise non-responder and group live training |
| Asynchronous content and health coaching and group trainingreceives asynchronous content, health coaching, and live group training | Behavioural | Asynchronous exercise and health coaching non-responder and group live training |
Primary outcome
Physical activity
Time frame: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32
The primary outcome is the change in physical activity (steps per day) from baseline to the end of the 32-week intervention. Participants wear Fitbit Inspire 3 trackers (Google LLC, Sacramento, CA) for continuous objective measurement, with data exported via the study dashboard. This is supplemented by the Godin Leisure-Time Exercise Questionnaire (GLETQ) at baseline, week-8 and week-16 for self-reported leisure-time activity in MET-minutes/week.
3 secondary outcomes
Health information technology literacy
Time frame: Baseline, week 8, week 16, and week 32
Secondary Health Conditions
Time frame: Baseline, week 8, week 16, and week 32
Activity limitations
Time frame: Baseline, week 8, week 16, and week 32
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 9 Jan 2026.
- Intervention landing page.Link provided by the sponsor.
- 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.
Mohanraj Thirumalai, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asynchronous content only, Asynchronous content and health coaching and no live training and asynchronous content only and 1 on 1 live training in people with Mobility Limitations and Disability Physical, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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 States. 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 Mohanraj Thirumalai, PhD (205-934-7189, mohanraj@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32). 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 Jan 2026.