FrailtyNCT05883423
Application of Frailty Prevention Care Management Program of Community Elderly Adults
A study testing FPCMP-Old Age in people with Frailty, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- FPCMP-Old Age
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community elders over 60 years old; able to communicate in Mandarin and Taiwanese and voluntarily participate in this course
Who cannot join
- Those who suffer from severe chronic diseases (such as heart disease, end-stage kidney disease, cancer) or severe illness, etc., and are unable to exercise
- Those who have severe visual and hearing impairments or use assistive devices without communication barriers
- Suffering from severe bone and joint diseases (for example: severe osteoporosis, severe knee or shoulder joint degeneration)
- Arrhythmia that requires drug treatment or a cardiac pacemaker
- Those with severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Frailty Prevention Care Management Program on Frailty and Health Function of Community Elderly Adults
This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community.
The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time.
The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.
Read the detailed description
Background ：The elderly are a high-risk group for developing frailty symptoms. The prevalence of frailty ranges from 16% for those over 65 years of age to 52% for those over 85 years of age, and it increases proportionally with age. Frailty is not a disease. It represents the cumulative functional degeneration of various systems. It is a sub-healthy state or a stage before disability. Some elderly people have different degrees of frailty. In mild cases, there may be no clinical symptoms. Interference part of life; more severe cases may lead to disability or disease.
Objective：This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community.
Methods：The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time.
Conclusions/practical application： The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.
- Conditions
- Frailty
- Being tested
- FPCMP-Old Age
- Keywords
- elderly adults, frailty prevention care management programs
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPCMP-Old AgeOther
- Exercise program：The main purpose of the exercise program is to improve cardiorespiratory endurance, upper and lower limb muscle strength and endurance, body flexibility, sense of balance and coordination. The exercise program is carried out with a suspension training system, which can improve core muscle strength, improve physical fitness, activate more core and stabilizing muscle groups, increase joint stability, and strengthen ligaments.
- Health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities involved)
| Study group | Role | What they receive |
|---|---|---|
| FPCMP-Old Age group | Experimental | The program mainly refers to Ha and Park (2020), and extends the development of the 12-week FPCMP-Old Age program, which combines sports and health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities). Twice a week, 2 hours each time, 12 weeks, a total of 24 times, the execution period is scheduled to be from July to the end of September. Receives: Other: FPCMP-Old Age |
| usual group | No intervention | Participate in the original health promotion activities of the community group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Taiwanese version of Tilburg frailty indicator(TFI-T)
This scale was translated by the researchers and other teams from The Taiwanese version of Tilburg frailty indicator (TFI-T) developed by Gobbens and other scholars in 2010. It is divided into three parts, with a total of 15 items. The first part measures physical frailty (score range 0 -8 points), including: Unexpected weight loss, physical fitness, difficulty walking, balance, visual problems, hearing problems, hand strength, and physical fatigue. The second part is mental frailty (score range 0-4 points), including: cognition, depressive symptoms, anxiety and coping ability. The third part is social-level frailty (score range 0-3 points), including: living alone, social relationship and social support, etc., with 0-1 points for each question, and a total score of 15 points.
Measured: It takes 5 minutes to fill out the questionnaire
Chronic Disease and Health Problems Scale
The research tools refer to the "Severity of Chronic Diseases and Health Problems" edited by Pan Baoxia (2012). There are 21 chronic diseases and health problems scales in total. Respondents are asked to self-evaluate their chronic diseases and The number of symptoms of health problems, and explore the severity of chronic diseases and health problems that interfere with daily life. The scoring method for the severity of interference is 0 points for "no inconvenience", 1 point for "slight inconvenience", and 2 points for "slight inconvenience". The total score ranges from 0 to 42 points. Chronic diseases or health problems affect life more seriously.
Measured: It takes 5 minutes to fill out the questionnaire
Health Function
Refer to the Senior Fitness Test (SFT) recommended by the Sports Administration of the Ministry of Education in 2016, which refers to the ability of subjects to perform daily activities independently without excessive fatigue and safety concerns. The muscles of the elderly are tested separately. Strength, Muscular Endurance, Cardiorespiratory Endurance, Body Flexibility, Balance, Coordination, Reaction Time and Body Composition
Measured: It takes 15 minutes to test health function
Nutritional Assessment
The Mini Nutritional Assessment-Short Form (MNA-SF) is used for assessment. MNA-SF has 6 questions, the minimum score range is 0-2 points, the maximum score range is 0-3 points, and the total score 14 points, if the score ≥ 11 points, it means that the nutritional status of the subject is within the acceptable range, 8-11 points: there is a risk of malnutrition, 0-7 points: malnutrition.
Measured: It takes 5 minutes to fill out the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chia Hui, Chang Gung Memorial Hospital
- Investigators
- Chia-Hui Lin, PhD, Study director, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883423
- Sponsor's protocol ID
- 202202269B0
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulmez I. Effects of Angle Variations in Suspension Push-up Exercise. J Strength Cond Res. 2017 Apr;31(4):1017-1023. doi: 10.1519/JSC.0000000000001401.
PubMed 26950344Ha J, Park YH. Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults. Int J Environ Res Public Health. 2020 Sep 13;17(18):6660. doi: 10.3390/ijerph17186660.
PubMed 32933119McDermott AY, Mernitz H. Exercise and older patients: prescribing guidelines. Am Fam Physician. 2006 Aug 1;74(3):437-44.
PubMed 16913163Lin CH, Liu MY. Efficacy of a nurse-led frailty prevention program on frailty reduction and functional health improvement in community-dwelling older adults in Taiwan: a quasi-experimental longitudinal study. Geriatr Nurs. 2026 Jul;71:104102. doi: 10.1016/j.gerinurse.2026.104102. Epub 2026 Jun 4.
PubMed 42241906
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Frailty Prevention Care Management Program on Frailty and Health Function of Community Elderly Adults
- ClinicalTrials.gov ID
- NCT05883423
- Acronym / sponsor ID
- 202202269B0
- Conditions
- Frailty
- Keywords
- elderly adults, frailty prevention care management programs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community.
The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time.
The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.
Detailed description
Background ：The elderly are a high-risk group for developing frailty symptoms. The prevalence of frailty ranges from 16% for those over 65 years of age to 52% for those over 85 years of age, and it increases proportionally with age. Frailty is not a disease. It represents the cumulative functional degeneration of various systems. It is a sub-healthy state or a stage before disability. Some elderly people have different degrees of frailty. In mild cases, there may be no clinical symptoms. Interference part of life; more severe cases may lead to disability or disease.
Objective：This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community.
Methods：The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time.
Conclusions/practical application： The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FPCMP-Old Age group | Experimental | Other: FPCMP-Old AgeThe program mainly refers to Ha and Park (2020), and extends the development of the 12-week FPCMP-Old Age program, which combines sports and health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities). Twice a week, 2 hours each time, 12 weeks, a total of 24 times, the execution period is scheduled to be from July to the end of September. |
| usual group | No intervention | –Participate in the original health promotion activities of the community group |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community elders over 60 years old; able to communicate in Mandarin and Taiwanese and voluntarily participate in this course
Key exclusion criteria (5 listed)
- Those who suffer from severe chronic diseases (such as heart disease, end-stage kidney disease, cancer) or severe illness, etc., and are unable to exercise
- Those who have severe visual and hearing impairments or use assistive devices without communication barriers
- Suffering from severe bone and joint diseases (for example: severe osteoporosis, severe knee or shoulder joint degeneration)
- Arrhythmia that requires drug treatment or a cardiac pacemaker
- Those with severe cognitive impairment.
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 |
|---|---|---|
| FPCMP-Old Age1. Exercise program：The main purpose of the exercise program is to improve cardiorespiratory endurance, upper and lower limb muscle strength and endurance, body flexibility, sense of balance and coordination. The exercise program is carried out with a suspension training system, which can improve core muscle strength, improve physical fitness, activate more core and stabilizing muscle groups, increase joint stability, and strengthen ligaments. 2. Health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities involved) | Other | FPCMP-Old Age group |
Primary outcome
The Taiwanese version of Tilburg frailty indicator(TFI-T)
Time frame: It takes 5 minutes to fill out the questionnaire
This scale was translated by the researchers and other teams from The Taiwanese version of Tilburg frailty indicator (TFI-T) developed by Gobbens and other scholars in 2010. It is divided into three parts, with a total of 15 items. The first part measures physical frailty (score range 0 -8 points), including: Unexpected weight loss, physical fitness, difficulty walking, balance, visual problems, hearing problems, hand strength, and physical fatigue. The second part is mental frailty (score range 0-4 points), including: cognition, depressive symptoms, anxiety and coping ability. The third part is social-level frailty (score range 0-3 points), including: living alone, social relationship and social support, etc., with 0-1 points for each question, and a total score of 15 points.
Chronic Disease and Health Problems Scale
Time frame: It takes 5 minutes to fill out the questionnaire
The research tools refer to the "Severity of Chronic Diseases and Health Problems" edited by Pan Baoxia (2012). There are 21 chronic diseases and health problems scales in total. Respondents are asked to self-evaluate their chronic diseases and The number of symptoms of health problems, and explore the severity of chronic diseases and health problems that interfere with daily life. The scoring method for the severity of interference is 0 points for "no inconvenience", 1 point for "slight inconvenience", and 2 points for "slight inconvenience". The total score ranges from 0 to 42 points. Chronic diseases or health problems affect life more seriously.
Health Function
Time frame: It takes 15 minutes to test health function
Refer to the Senior Fitness Test (SFT) recommended by the Sports Administration of the Ministry of Education in 2016, which refers to the ability of subjects to perform daily activities independently without excessive fatigue and safety concerns. The muscles of the elderly are tested separately. Strength, Muscular Endurance, Cardiorespiratory Endurance, Body Flexibility, Balance, Coordination, Reaction Time and Body Composition
Nutritional Assessment
Time frame: It takes 5 minutes to fill out the questionnaire
The Mini Nutritional Assessment-Short Form (MNA-SF) is used for assessment. MNA-SF has 6 questions, the minimum score range is 0-2 points, the maximum score range is 0-3 points, and the total score 14 points, if the score ≥ 11 points, it means that the nutritional status of the subject is within the acceptable range, 8-11 points: there is a risk of malnutrition, 0-7 points: malnutrition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 26950344Gulmez I. Effects of Angle Variations in Suspension Push-up Exercise. J Strength Cond Res. 2017 Apr;31(4):1017-1023. doi: 10.1519/JSC.0000000000001401.
- Results publication: PubMed 32933119Ha J, Park YH. Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults. Int J Environ Res Public Health. 2020 Sep 13;17(18):6660. doi: 10.3390/ijerph17186660.
- Results publication: PubMed 16913163McDermott AY, Mernitz H. Exercise and older patients: prescribing guidelines. Am Fam Physician. 2006 Aug 1;74(3):437-44.
- Derived from this study: PubMed 42241906Lin CH, Liu MY. Efficacy of a nurse-led frailty prevention program on frailty reduction and functional health improvement in community-dwelling older adults in Taiwan: a quasi-experimental longitudinal study. Geriatr Nurs. 2026 Jul;71:104102. doi: 10.1016/j.gerinurse.2026.104102. Epub 2026 Jun 4.
- Individual participant dataSharing planned: No
Related trials for Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hui Lin, PhD study director
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPCMP-Old Age in people with Frailty, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hui Lin, PhD (+886-912748610, clh9031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Taiwanese version of Tilburg frailty indicator(TFI-T) (time frame: It takes 5 minutes to fill out the questionnaire). The study lists 4 primary outcomes in all. 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 NCT05883423, which also lists 4 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 1 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.