Cognition DisordersNCT07658469
Moderate-Intensity Aerobic Calisthenics for Rural Elderly With Motoric Cognitive Risk Syndrome
A study testing moderate-intensity aerobic exercise and Routine Care in people with Cognition Disorders and Aged, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a "golden window of… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders, Aged
- What is being tested?
- moderate-intensity aerobic exercise and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Jan 2027
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥60 years;
- Meeting the diagnostic criteria for Motor Cognitive Risk Syndrome (MCR);
- Clear consciousness and ability to communicate clearly;
- Permanent residents of rural areas in nine prefecture-level cities of Fujian Province (with an annual residence of ≥9 months) and no plan to relocate within the next year; -⑤ Willing to voluntarily participate and sign the informed consent form.
Who cannot join
- Presence of severe mental disorders, history of stroke, Parkinson's disease, or severe visual/auditory impairments;
- Physical disability that prevents independent walking;
- Comorbid severe systemic diseases, such as cardiopulmonary conditions; -④ Regular exercise habits within the past 6 months (≥30 minutes/day, ≥3 days/week) or a long-term history of exercise; -⑤ Current participation in other interventional studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Application of Moderate-Intensity Aerobic Calisthenics in Rural Elderly With Motoric Cognitive Risk Syndrome
The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a "golden window of opportunity" for the early prevention and treatment of dementia. Currently, there is no specific pharmacological treatment for MCR; non-pharmacological interventions, particularly exercise interventions, are key strategies. Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is economical, simple, highly engaging, safe, and has demonstrated potential for improving both cognitive and gait function, making it especially suitable for promotion in resource-limited rural settings. However, there is a lack of systematic, theory-guided exercise intervention protocols and effectiveness validation for rural older adults with MCR. Therefore, this study aims to develop and validate a moderate-intensity aerobic calisthenics intervention protocol tailored to this population.
Read the detailed description
Motor Cognitive Risk Syndrome (MCR), first defined by Verghese et al. in 2013, refers to the coexistence of subjective cognitive decline and slow gait in older adults without dementia or movement disorders, representing a novel pre-dementia syndrome situated between normal aging and dementia. The global prevalence of MCR is 9.0% (range: 2.4%-33.3%) , and the prevalence among Chinese older adults ranges from 4.00% to 13.85% , with higher rates in rural than urban areas-reaching as high as 16.7% in rural Anhui Province. MCR significantly increases the risk of dementia (three-fold) and particularly vascular dementia (12-fold) , and also elevates the incidence of falls, disability, and mortality. Cohort studies have shown that 22.1% of individuals with MCR progress to dementia, 57.5% remain in the MCR state, and 20.3% revert to normal cognition. This reversibility suggests that MCR represents a critical window for the ultra-early prevention and treatment of dementia.
Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is a form of moderate-intensity aerobic exercise. Evidence indicates that it effectively improves cognitive and physical function in older adults, exerts superior cognitive benefits compared to other exercise types, and reduces loneliness and depressive symptoms. The participation rate in physical exercise among older adults in rural China is only 33.9%-48.29%, limited by objective constraints such as lack of facilities and equipment, and monotonous forms of exercise. Aerobic calisthenics, characterized by its economy, simplicity, high appeal, and safety, is well-suited for promotion in rural areas. However, no studies to date have reported the application effects of this intervention in the MCR population, and thus investigating its intervention value in rural older adults with MCR holds significant research importance.
- Conditions
- Cognition Disorders, Aged
- Being tested
- moderate-intensity aerobic exercise, Routine Care
- Keywords
- MCR, Motoric Cognitive Risk Syndrome, moderate-intensity aerobic exercise, rural areas, Aged
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate-intensity aerobic exerciseOther
Based on routine health education, the intervention group receives a 12-week moderate-intensity aerobic exercise intervention (Jiamusi Happy Dance Steps) lasting 60 minutes per session, three times per week, delivered in a group setting, followed by a 12-week follow-up period.
Routine CareOther
While maintaining daily living habits unchanged, provide knowledge related to health education for Motor Cognitive Risk Syndrome (MCR) and receive the MCR health education manual.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity aerobic exercise | Experimental | The group was intervened with a moderate-intensity aerobic exercise program developed by the research team. Receives: Other: moderate-intensity aerobic exercise |
| Routine Care | Experimental | This group of elderly people maintained their daily routines and received health education. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Basic
The MoCA-B was jointly developed by the Montreal Cognitive Assessment Clinic and Research Institute in Canada, in collaboration with the Prince Mahidol Award Foundation of Thailand and the Faculty of Medicine at Chulalongkorn University. It has a total score of 30 points and encompasses eight cognitive domains: executive function, language, orientation, calculation, abstract thinking, memory, visual perception, and attention, with higher scores indicating better cognitive function. The cutoff values are as follows: for years of education ≤6 years, MoCA-B ≥20; for 6 years < years of education ≤12 years, MoCA-B ≥23; and for years of education >12 years, MoCA-B ≥25. The scale correctly identifies cognitively normal participants with a specificity of 86%, and demonstrates a sensitivity of 81% for detecting cognitive impairment. The Cronbach's α coefficient of the scale is 0.807, and the criterion valid
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Walking speed
The timed walking test was used to measure gait speed. The required equipment included a tape measure and a stopwatch. The specific procedure was as follows: First, a straight 6-meter course was measured using the tape measure, and the middle 4-meter segment was marked. The participant stood at the starting point. Then, upon the tester's command "Start," the participant walked at their normal pace to the endpoint. The time taken to cover the middle 4 meters was recorded using the same stopwatch. This was performed twice. Finally, gait speed was calculated using the formula speed = distance / time, with the average time of the two trials used for calculation.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Secondary outcomes (9)
Subjective Cognitive Decline-questionnaire 9
The SCD-Q9 was adapted and revised into Chinese by Hao Lixiao et al. It encompasses two dimensions: global memory ability with time comparison, and activities of daily living. It primarily assesses memory, recall ability, language ability, attention, orientation, and other domains. The questionnaire consists of 9 items. The scoring reference criteria for item responses are as follows: "Yes" = 1 point, "No" = 0 points, "Often" = 1 point, "Occasionally" = 0.5 points. The total score ranges from 0 to 9 points, with higher scores indicating a greater likelihood of cognitive impairment. A score of ≥5 points suggests the possible presence of potential memory impairment.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
short physical performance battery
The Short Physical Performance Battery (SPPB), developed by the National Institute on Aging (NIH), objectively assesses balance, lower limb strength, and physical function in older adults. Originally designed to predict disability, institutionalization, or mortality, it is now widely used for frailty, fall risk, and disease-related functional impairment. The SPPB includes three tests: balance, 4-meter gait speed, and five-repetition sit-to-stand, each scored 0-4, total 0-12 (higher = better function). Scores 0-3: severe mobility limitation with daily living difficulties; 4-6: mild limitation, needing assistance or aids; 7-9: normal mobility, independent in daily activities; 10-12: excellent mobility, robust and strong.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Handgrip strength
A electronic hand dynamometer (CAMRY, USA) was used to assess the upper limb muscle strength of the participants. Before measurement, the staff adjusted the dynamometer to zero. During the test, the participant stood in a natural posture with both arms hanging naturally at the sides. The dynamometer was kept as suspended as possible without touching the body, while maintaining the device stable. The participant was instructed to relax and then squeeze the dynamometer forcefully with the dominant hand three times (with an interval of >15 seconds between each attempt). The maximum value among the three attempts was recorded as the grip strength.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Body fat
Body composition was assessed using bioelectrical impedance analysis (BIA) with an InBody H20N body fat scale, primarily measuring muscle and fat-related parameters. Before testing, participants wore light clothing without metal accessories and removed metal items such as watches, rings, and necklaces. During testing, participants stood barefoot on the metal electrode plates with feet shoulder-width apart, ensuring close contact of heels and forefeet with the plates. They held the handles on both sides with arms hanging naturally, hands dry and not touching the trunk. The operator initiated the measurement, during which participants remained still, silent, and motionless. The measurement lasted 1-2 minutes, and the device introduced a low-intensity electrical current to determine bioelectrical impedance parameters and estimate body composition.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
12-Item Short-Form Health Survey
The SF-12, a shortened version of the 36-Item Short-Form Health Survey (SF-36), assesses health-related quality of life. It retains the eight dimensions of the SF-36 with 12 items, covering general health (GH), physical functioning (PF), role physical (RP), bodily pain (BP), role emotional (RE), mental health (MH), vitality (VT), and social functioning (SF). The first four dimensions evaluate physical component summary (PCS), and the latter four evaluate mental component summary (MCS). The total score ranges from 0 to 100, with higher scores indicating better quality of life. Xiao Huimin et al. demonstrated good reliability and validity of the SF-12 among Chinese older adults.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Patient Health Questionnaire-9
The 9-item Patient Health Questionnaire (PHQ-9) assesses depressive symptom severity over the past two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day), with a total score ranging from 0 to 27 (higher scores indicate greater depression severity). Cutoff scores: 0-4 = no depression; 5-9 = possible mild depression; 10-14 = moderate depression risk; ≥15 = severe depressive symptoms. The scale has good internal consistency (Cronbach's α = 0.894).
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Generalized Anxiety Disorder-7 item
The 7-item Generalized Anxiety Disorder scale (GAD-7) assesses the severity of anxiety symptoms over the past two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day), with a total score ranging from 0 to 21 (higher scores indicate greater anxiety severity). Cutoff scores: 0-4 = no anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; ≥15 = severe anxiety. The scale has good internal consistency (Cronbach's α = 0.840) and demonstrates good reliability and validity in the Chinese population.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
World Health Organization Well-being Index
The WHO-5 Well-Being Index, developed by Bech and revised by the WHO Collaborating Centre for Research in Mental Health, assesses subjective well-being over the past two weeks. The scale consists of 5 items, each rated on a 6-point scale (0 = none, 1 = a little of the time, 2 = less than half the time, 3 = more than half the time, 4 = most of the time, 5 = all the time). The raw sum is multiplied by 4 to obtain a standardized total score ranging from 0 to 100, with higher scores indicating better well-being. The scale has good internal consistency (Cronbach's α = 0.86) . A score below 50 indicates reduced well-being [144]. In this study, well-being is categorized as high (≥70), moderate (50-70), and low (≤50).
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
The Theory of Planned Behavior Questionnaire (Exercise Version)
The Theory of Planned Behavior Questionnaire, developed by Icek Ajzen, consists of 12 items across four dimensions: behavioral attitude, subjective norm, perceived behavioral control, and behavioral intention. It is used to measure the social cognitive variables of the theory of planned behavior. The target behavior in this questionnaire refers to the exercise goal set for rural older adults with Motor Cognitive Risk Syndrome (i.e., participating in at least 150 minutes of moderate-intensity aerobic exercise per week). Items are rated on a 7-point Likert scale, ranging from "strongly disagree" to "strongly agree," with scores from 1 to 7. Higher scores indicate greater levels of agreement.
Measured: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjiao Yan, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658469
- Sponsor's protocol ID
- 2026-04-27
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Application of Moderate-Intensity Aerobic Calisthenics in Rural Elderly With Motoric Cognitive Risk Syndrome
- ClinicalTrials.gov ID
- NCT07658469
- Acronym / sponsor ID
- 2026-04-27
- Conditions
- Cognition Disorders, Aged
- Keywords
- MCR, Motoric Cognitive Risk Syndrome, moderate-intensity aerobic exercise, rural areas, Aged
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 Jun 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.
The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a "golden window of opportunity" for the early prevention and treatment of dementia. Currently, there is no specific pharmacological treatment for MCR; non-pharmacological interventions, particularly exercise interventions, are key strategies. Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is economical, simple, highly engaging, safe, and has demonstrated potential for improving both cognitive and gait function, making it especially suitable for promotion in resource-limited rural settings. However, there is a lack of systematic, theory-guided exercise intervention protocols and effectiveness validation for rural older adults with MCR. Therefore, this study aims to develop and validate a moderate-intensity aerobic calisthenics intervention protocol tailored to this population.
Detailed description
Motor Cognitive Risk Syndrome (MCR), first defined by Verghese et al. in 2013, refers to the coexistence of subjective cognitive decline and slow gait in older adults without dementia or movement disorders, representing a novel pre-dementia syndrome situated between normal aging and dementia. The global prevalence of MCR is 9.0% (range: 2.4%-33.3%) , and the prevalence among Chinese older adults ranges from 4.00% to 13.85% , with higher rates in rural than urban areas-reaching as high as 16.7% in rural Anhui Province. MCR significantly increases the risk of dementia (three-fold) and particularly vascular dementia (12-fold) , and also elevates the incidence of falls, disability, and mortality. Cohort studies have shown that 22.1% of individuals with MCR progress to dementia, 57.5% remain in the MCR state, and 20.3% revert to normal cognition. This reversibility suggests that MCR represents a critical window for the ultra-early prevention and treatment of dementia.
Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is a form of moderate-intensity aerobic exercise. Evidence indicates that it effectively improves cognitive and physical function in older adults, exerts superior cognitive benefits compared to other exercise types, and reduces loneliness and depressive symptoms. The participation rate in physical exercise among older adults in rural China is only 33.9%-48.29%, limited by objective constraints such as lack of facilities and equipment, and monotonous forms of exercise. Aerobic calisthenics, characterized by its economy, simplicity, high appeal, and safety, is well-suited for promotion in rural areas. However, no studies to date have reported the application effects of this intervention in the MCR population, and thus investigating its intervention value in rural older adults with MCR holds significant research importance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity aerobic exercise | Experimental | Other: moderate-intensity aerobic exerciseThe group was intervened with a moderate-intensity aerobic exercise program developed by the research team. |
| Routine Care | Experimental | Other: Routine CareThis group of elderly people maintained their daily routines and received health education. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥60 years;
Key exclusion criteria (3 listed)
- Presence of severe mental disorders, history of stroke, Parkinson's disease, or severe visual/auditory impairments;
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 |
|---|---|---|
| moderate-intensity aerobic exerciseBased on routine health education, the intervention group receives a 12-week moderate-intensity aerobic exercise intervention (Jiamusi Happy Dance Steps) lasting 60 minutes per session, three times per week, delivered in a group setting, followed by a 12-week follow-up period. | Other | Moderate-intensity aerobic exercise |
| Routine CareWhile maintaining daily living habits unchanged, provide knowledge related to health education for Motor Cognitive Risk Syndrome (MCR) and receive the MCR health education manual. | Other | Routine Care |
Primary outcome
Montreal Cognitive Assessment Basic
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
The MoCA-B was jointly developed by the Montreal Cognitive Assessment Clinic and Research Institute in Canada, in collaboration with the Prince Mahidol Award Foundation of Thailand and the Faculty of Medicine at Chulalongkorn University. It has a total score of 30 points and encompasses eight cognitive domains: executive function, language, orientation, calculation, abstract thinking, memory, visual perception, and attention, with higher scores indicating better cognitive function. The cutoff values are as follows: for years of education ≤6 years, MoCA-B ≥20; for 6 years < years of education ≤12 years, MoCA-B ≥23; and for years of education >12 years, MoCA-B ≥25. The scale correctly identifies cognitively normal participants with a specificity of 86%, and demonstrates a sensitivity of 81% for detecting cognitive impairment. The Cronbach's α coefficient of the scale is 0.807, and the criterion valid
Walking speed
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
The timed walking test was used to measure gait speed. The required equipment included a tape measure and a stopwatch. The specific procedure was as follows: First, a straight 6-meter course was measured using the tape measure, and the middle 4-meter segment was marked. The participant stood at the starting point. Then, upon the tester's command "Start," the participant walked at their normal pace to the endpoint. The time taken to cover the middle 4 meters was recorded using the same stopwatch. This was performed twice. Finally, gait speed was calculated using the formula speed = distance / time, with the average time of the two trials used for calculation.
9 secondary outcomes
Subjective Cognitive Decline-questionnaire 9
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
short physical performance battery
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Handgrip strength
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Body fat
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
12-Item Short-Form Health Survey
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Patient Health Questionnaire-9
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
Generalized Anxiety Disorder-7 item
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
World Health Organization Well-being Index
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
The Theory of Planned Behavior Questionnaire (Exercise Version)
Time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 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 22 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate-intensity aerobic exercise and Routine Care in people with Cognition Disorders and Aged, run by Fujian Provincial Hospital at 1 site in China.
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 4 inclusion and 3 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 22 Jun 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 China. 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 Tuantuan Guo (+86 159 5989 7344, 390977233@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Basic (time frame: The intervention was carried out in August 2026, and the assessment period was 0,3,6 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 22 Jun 2026.