Physical ActivityNCT07919171
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
A study testing Virtual reality physical activity health promotion intervention in people with Physical Activity and Intellectual Disabilities, run by Michigan State University.
Trial summary
Adolescents with intellectual disabilities (ID) face significant health issues, particularly in managing chronic conditions such as cardiovascular (CV) health risks. These issues are exacerbated by limited physical activity (PA), health literacy challenges, and a lack of evidence-based health interventions. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Intellectual Disabilities, Cardiovascular Health
- What is being tested?
- Virtual reality physical activity health promotion intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Jan 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Adolescents with intellectual disabilities (ID) face significant health issues, particularly in managing chronic conditions such as cardiovascular (CV) health risks. These issues are exacerbated by limited physical activity (PA), health literacy challenges, and a lack of evidence-based health interventions. This project aims to address these gaps by engaging adolescents with ID and their stakeholders supporting ID as co-researchers to design, adapt, and pilot-test a virtual reality (VR)-based PA intervention tailored to their needs. The long-term goal is to dismantle factors to improve health outcomes for adolescents with ID through innovative, collaborative research that enhances health literacy, increases PA, and lowers CV health risks. The objectives of this study will address three specific aims: 1) adapt and validate research instruments by collaborating with adolescents with ID and their ID stakeholders to incorporate common language in measures for assessing health outcomes; 2) evaluate and select VR-based PA programs by engaging co-researchers in identifying effective VR exergame interventions for improving health outcomes through PA; and 3) pilot-test the VR PA intervention, which incorporates peer support. We will assess feasibility, acceptability, and preliminary efficacy of our 16-week VR exergame PA intervention using co-adapted measures and biologic CV risk measures. A quasi-experimental mixed-methods approach will be used, guided by our Logic Model. Preliminary evidence highlights the potential of interactive, technology-driven PA to address CV risks while fostering peer engagement and optimal self-efficacy to manage health. The expected outcomes are: 1) validated measures through greater health literacy, and 2) a co-designed intervention to reduce CV risks that helps adolescents with ID to take an active role in their health. By addressing critical gaps in health literacy, self-efficacy, and PA, this work advances healthcare practices and supports long-term improvements in public health.
- Being tested
- Virtual reality physical activity health promotion intervention
- Keywords
- Intellectual Disability, Adolescent, Virtual Reality, Health Literacy
- Medical subject headings
- Motor Activity, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality physical activity health promotion interventionBehavioural
The intervention will be delivered via home setting of the study participant (adolescent with ID). Baseline Home Visit; week 1: All pre-intervention baseline measures will be obtained, accelerometer will be fitted and applied. Home Visit 2; week 2: The participant will utilize the VR technology three sessions per week (weeks 3-16) for approximately 10 minutes per exercise session following instructions on use. Visit 3; Virtual; week 4: One of the three VR sessions per week will be virtual peer group interactions, guided by study staff. Virtual peer groups will utilize the VR technology together for at least one session of the three sessions per week for approximately 10 minutes per exercise session during weeks 4-16. Educational materials include: visual supports to guide VR use along with study team's contact information throughout the intervention. Study Completion Home Visit; after week 15: Follow up data collection. Virtual Week 16; Optional: Qualitative follow-up data collection.
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Single arm study participants will be asked to utilize a VR exercise program and complete pre/post surveys Receives: Behavioral: Virtual reality physical activity health promotion intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph.
Measured: Baseline and at 16 weeks
Secondary outcomes (10)
Feasibility of Intervention
4-item, validated measure to evaluate the feasibility of immersive VR intervention.
Measured: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Acceptability of Intervention
4-item, validated measure to evaluate the acceptability of immersive VR intervention
Measured: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Virtual Reality Symptoms
4-item, to measure the symptoms one experiences while or after being in a VR environment. Symptoms that have been associated with VR use (general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness with eyes closed, vertigo)
Measured: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
12-item, validated measure to assess perceptions of social support adequacy from three sources: family, friends, and significant other (subscales)
Measured: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Self-efficacy for Exercise (MSES)
9-item, measure to assess three behavioral domains (i.e., task efficacy, coping efficacy, scheduling efficacy) that relate to exercise behavior among individuals and exercise contexts. The three behavioral domains are useful in determining the dimensions that influence exercise in a particular population segment
Measured: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Body Mass Index (BMI)
Measure of estimated body fat based on a person's height and weight. Portable stadiometer and scale use to measure height and weight
Measured: At baseline, 16 weeks
Waist circumference
Measure of the distance around a person's waist as a health indicator to assess risk of excess body fat for developing a chronic condition. Measuring tape utilized
Measured: At baseline, 16 weeks
Calories Burned
Measure of the rate at which an individual burns calories based on the height, weight, age, and gender entered into an individual's app account.
Fitbit wearable activity monitor and mobile app utilized
Measured: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Heart Rate
Measure of number of individual's heart beats per minute (bpm) with various activities. Fitbit wearable activity monitor and mobile app utilized
Measured: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Active Zone Minutes per Day
Measure of the time an individual spends in different heart rate zones. Fitbit wearable activity monitor and mobile app utilized
Measured: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The overall design of the proposed research is a two-phased quasi-experimental mixed-methods design with an exploratory sequential and convergent design. All participants are assigned to one single arm and receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Patricia West, Michigan State University
- Investigators
- Patricia M West, PhD, RN, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919171
- Sponsor's protocol ID
- STUDY202600294
- Other IDs
- 1K01NR022135-01
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mammen JR, Java JJ, Rhee H, Butz AM, Halterman JS, Arcoleo K. Mixed-methods content and sentiment analysis of adolescents' voice diaries describing daily experiences with asthma and self-management decision-making. Clin Exp Allergy. 2019 Mar;49(3):299-307. doi: 10.1111/cea.13250. Epub 2018 Sep 18.
PubMed 30113733Mammen JR, McGovern CM, Schoonmaker JD, Philibert A, Schlegel EC, Arcoleo K. A multilevel perspective on goals, barriers, and facilitators of school-based asthma management. J Asthma. 2022 Dec;59(12):2461-2474. doi: 10.1080/02770903.2021.2018704. Epub 2021 Dec 28.
PubMed 34962442Arcoleo K, Zayas LE, Hawthorne A, Begay R. Illness representations and cultural practices play a role in patient-centered care in childhood asthma: experiences of Mexican mothers. J Asthma. 2015 Sep;52(7):699-706. doi: 10.3109/02770903.2014.1001905. Epub 2015 Mar 10.
PubMed 25539396Kunselman AR. A brief overview of pilot studies and their sample size justification. Fertil Steril. 2024 Jun;121(6):899-901. doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6.
PubMed 38331310Hauck, J., Fisher, M., & West, P. (2024-2025). Health and the Role of Employment Among Young Adults with Intellectual and Developmental Disabilities [Grant]. Michigan State University Research Foundation and TETRAD Program. https://research.msu.edu/news/tetrad-awards-announced-2024
Mirza M, Brown-Hollie JP, Suarez-Balcazar Y, Parra-Medina D, Camillone S, Zeng W, Garcia-Gomez E, Heydarian N, Magana S. Interventions for Health Promotion and Obesity Prevention for Children and Adolescents with Developmental Disabilities: a Systematic Review. Rev J Autism Dev Disord. 2022 Aug 22:1-24. doi: 10.1007/s40489-022-00335-5. Online ahead of print.
PubMed 36032995Bandini L, Danielson M, Esposito LE, Foley JT, Fox MH, Frey GC, Fleming RK, Krahn G, Must A, Porretta DL, Rodgers AB, Stanish H, Urv T, Vogel LC, Humphries K. Obesity in children with developmental and/or physical disabilities. Disabil Health J. 2015 Jul;8(3):309-16. doi: 10.1016/j.dhjo.2015.04.005. Epub 2015 May 7.
PubMed 26058685Saure E, Castren M, Mikkola K, Salmi J. Intellectual disabilities moderate sex/gender differences in autism spectrum disorder: a systematic review and meta-analysis. J Intellect Disabil Res. 2023 Jan;67(1):1-34. doi: 10.1111/jir.12989. Epub 2022 Nov 29.
PubMed 36444668Polyak A, Rosenfeld JA, Girirajan S. An assessment of sex bias in neurodevelopmental disorders. Genome Med. 2015 Aug 27;7(1):94. doi: 10.1186/s13073-015-0216-5.
PubMed 26307204Yu S, Wang T, Zhong T, Qian Y, Qi J. Barriers and Facilitators of Physical Activity Participation among Children and Adolescents with Intellectual Disabilities: A Scoping Review. Healthcare (Basel). 2022 Jan 26;10(2):233. doi: 10.3390/healthcare10020233.
PubMed 35206848Rodgers WM, Wilson PM, Hall CR, Fraser SN, Murray TC. Evidence for a multidimensional self-efficacy for exercise scale. Res Q Exerc Sport. 2008 Jun;79(2):222-34. doi: 10.1080/02701367.2008.10599485.
PubMed 18664046Zimet, G.D., Dahlem, N.W, Zimet, S.G., & Farley, G.K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2
Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
PubMed 29477332Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Pett MA, Guo JW, Cardell B, Johnson EP, Guerra N, Clark L. Psychometric properties of a brief self-reported health-related quality of life measure (HRQoL-IDD) for persons with intellectual and developmental disabilities. J Appl Res Intellect Disabil. 2021 May;34(3):877-890. doi: 10.1111/jar.12831. Epub 2021 Jan 31.
PubMed 33522020
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
- ClinicalTrials.gov ID
- NCT07919171
- Acronym / sponsor ID
- STUDY202600294
- Keywords
- Intellectual Disability, Adolescent, Virtual Reality, Health Literacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 5 Nov 2026 (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.
Adolescents with intellectual disabilities (ID) face significant health issues, particularly in managing chronic conditions such as cardiovascular (CV) health risks. These issues are exacerbated by limited physical activity (PA), health literacy challenges, and a lack of evidence-based health interventions. This project aims to address these gaps by engaging adolescents with ID and their stakeholders supporting ID as co-researchers to design, adapt, and pilot-test a virtual reality (VR)-based PA intervention tailored to their needs. The long-term goal is to dismantle factors to improve health outcomes for adolescents with ID through innovative, collaborative research that enhances health literacy, increases PA, and lowers CV health risks. The objectives of this study will address three specific aims: 1) adapt and validate research instruments by collaborating with adolescents with ID and their ID stakeholders to incorporate common language in measures for assessing health outcomes; 2) evaluate and select VR-based PA programs by engaging co-researchers in identifying effective VR exergame interventions for improving health outcomes through PA; and 3) pilot-test the VR PA intervention, which incorporates peer support. We will assess feasibility, acceptability, and preliminary efficacy of our 16-week VR exergame PA intervention using co-adapted measures and biologic CV risk measures. A quasi-experimental mixed-methods approach will be used, guided by our Logic Model. Preliminary evidence highlights the potential of interactive, technology-driven PA to address CV risks while fostering peer engagement and optimal self-efficacy to manage health. The expected outcomes are: 1) validated measures through greater health literacy, and 2) a co-designed intervention to reduce CV risks that helps adolescents with ID to take an active role in their health. By addressing critical gaps in health literacy, self-efficacy, and PA, this work advances healthcare practices and supports long-term improvements in public health.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The overall design of the proposed research is a two-phased quasi-experimental mixed-methods design with an exploratory sequential and convergent design. All participants are assigned to one single arm and receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Behavioral: Virtual reality physical activity health promotion interventionSingle arm study participants will be asked to utilize a VR exercise program and complete pre/post surveys |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Virtual reality physical activity health promotion interventionThe intervention will be delivered via home setting of the study participant (adolescent with ID). Baseline Home Visit; week 1: All pre-intervention baseline measures will be obtained, accelerometer will be fitted and applied. Home Visit 2; week 2: The participant will utilize the VR technology three sessions per week (weeks 3-16) for approximately 10 minutes per exercise session following instructions on use. Visit 3; Virtual; week 4: One of the three VR sessions per week will be virtual peer group interactions, guided by study staff. Virtual peer groups will utilize the VR technology together for at least one session of the three sessions per week for approximately 10 minutes per exercise session during weeks 4-16. Educational materials include: visual supports to guide VR use along with study team's contact information throughout the intervention. Study Completion Home Visit; after week 15: Follow up data collection. Virtual Week 16; Optional: Qualitative follow-up data collection. | Behavioural | Single |
Primary outcome
Physical Activity
Time frame: Baseline and at 16 weeks
Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph.
10 secondary outcomes
Feasibility of Intervention
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Acceptability of Intervention
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Virtual Reality Symptoms
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Self-efficacy for Exercise (MSES)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Body Mass Index (BMI)
Time frame: At baseline, 16 weeks
Waist circumference
Time frame: At baseline, 16 weeks
Calories Burned
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Heart Rate
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Active Zone Minutes per Day
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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 5 Nov 2026.
- Background: PubMed 30113733Mammen JR, Java JJ, Rhee H, Butz AM, Halterman JS, Arcoleo K. Mixed-methods content and sentiment analysis of adolescents' voice diaries describing daily experiences with asthma and self-management decision-making. Clin Exp Allergy. 2019 Mar;49(3):299-307. doi: 10.1111/cea.13250. Epub 2018 Sep 18.
- Background: PubMed 34962442Mammen JR, McGovern CM, Schoonmaker JD, Philibert A, Schlegel EC, Arcoleo K. A multilevel perspective on goals, barriers, and facilitators of school-based asthma management. J Asthma. 2022 Dec;59(12):2461-2474. doi: 10.1080/02770903.2021.2018704. Epub 2021 Dec 28.
- Background: PubMed 25539396Arcoleo K, Zayas LE, Hawthorne A, Begay R. Illness representations and cultural practices play a role in patient-centered care in childhood asthma: experiences of Mexican mothers. J Asthma. 2015 Sep;52(7):699-706. doi: 10.3109/02770903.2014.1001905. Epub 2015 Mar 10.
- Background: PubMed 38331310Kunselman AR. A brief overview of pilot studies and their sample size justification. Fertil Steril. 2024 Jun;121(6):899-901. doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6.
- BackgroundHauck, J., Fisher, M., & West, P. (2024-2025). Health and the Role of Employment Among Young Adults with Intellectual and Developmental Disabilities [Grant]. Michigan State University Research Foundation and TETRAD Program. https://research.msu.edu/news/tetrad-awards-announced-2024
- Background: PubMed 36032995Mirza M, Brown-Hollie JP, Suarez-Balcazar Y, Parra-Medina D, Camillone S, Zeng W, Garcia-Gomez E, Heydarian N, Magana S. Interventions for Health Promotion and Obesity Prevention for Children and Adolescents with Developmental Disabilities: a Systematic Review. Rev J Autism Dev Disord. 2022 Aug 22:1-24. doi: 10.1007/s40489-022-00335-5. Online ahead of print.
- Background: PubMed 26058685Bandini L, Danielson M, Esposito LE, Foley JT, Fox MH, Frey GC, Fleming RK, Krahn G, Must A, Porretta DL, Rodgers AB, Stanish H, Urv T, Vogel LC, Humphries K. Obesity in children with developmental and/or physical disabilities. Disabil Health J. 2015 Jul;8(3):309-16. doi: 10.1016/j.dhjo.2015.04.005. Epub 2015 May 7.
- Background: PubMed 36444668Saure E, Castren M, Mikkola K, Salmi J. Intellectual disabilities moderate sex/gender differences in autism spectrum disorder: a systematic review and meta-analysis. J Intellect Disabil Res. 2023 Jan;67(1):1-34. doi: 10.1111/jir.12989. Epub 2022 Nov 29.
- Background: PubMed 26307204Polyak A, Rosenfeld JA, Girirajan S. An assessment of sex bias in neurodevelopmental disorders. Genome Med. 2015 Aug 27;7(1):94. doi: 10.1186/s13073-015-0216-5.
- Background: PubMed 35206848Yu S, Wang T, Zhong T, Qian Y, Qi J. Barriers and Facilitators of Physical Activity Participation among Children and Adolescents with Intellectual Disabilities: A Scoping Review. Healthcare (Basel). 2022 Jan 26;10(2):233. doi: 10.3390/healthcare10020233.
- Background: PubMed 18664046Rodgers WM, Wilson PM, Hall CR, Fraser SN, Murray TC. Evidence for a multidimensional self-efficacy for exercise scale. Res Q Exerc Sport. 2008 Jun;79(2):222-34. doi: 10.1080/02701367.2008.10599485.
- BackgroundZimet, G.D., Dahlem, N.W, Zimet, S.G., & Farley, G.K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2
- Individual participant dataSharing planned: Yes
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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.
Patricia M West, PhD, RN principal investigator
Michigan State University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality physical activity health promotion intervention in people with Physical Activity and Intellectual Disabilities, run by Michigan State University.
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 0 inclusion and 1 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Patricia M West, PhD, RN (517-432-8356, westpatr@msu.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: Baseline and at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919171, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.