Community-dwelling Older AdultsNCT04801316
Steady Feet: Proof of Value
A study testing Steady Feet exercise programme and Steady Feet Video in people with Community-dwelling Older Adults and Fall Risk, run by Changi General Hospital at 1 site in Singapore.
Trial summary
It is well established that poorer functional performance is associated with falls in older adults. Exercise is shown to be an effective evidence-based intervention in improving functional performance. However, there is a lack of a specially tailored structured exercise intervention in Singapore to address this. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Older Adults, Fall Risk
- What is being tested?
- Steady Feet exercise programme and Steady Feet Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Nov 2021to 31 Dec 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years and older
- SPPB score: 7 to 10
- Passes at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- Does not possess significant cognitive impairment (AMT ≥ 5)
Who cannot join
- Male or female aged < 60 years old
- SPPB score of ≥ 11 or ≤ 6
- Did not pass at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- Possess significant cognitive impairment (AMT < 5)
Trial locations and contacts
1 site in 1 country.
About this study
It is well established that poorer functional performance is associated with falls in older adults. Exercise is shown to be an effective evidence-based intervention in improving functional performance. However, there is a lack of a specially tailored structured exercise intervention in Singapore to address this. In response, a 6-months community-based structured exercise programme, called "Steady Feet" (SF) was developed. It aimed to improve physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls.
Concurrently, COVID-19 led to reduced training and exercise opportunities. There is now a need for alternatives to aid in the training of community instructors, and to carry out exercise programmes for community-dwelling older adults.
Thus, the objectives of this study are to examine (1) evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the SF classes. (2) Evaluate the effects of the SF programme (intervention group) on functional status among older adults (aged 60 years and above), compared with a group of older adults that did not participate in the SF programme (control group).
Read the detailed description
There will be two parts to this study, part 1: a feasibility study, and part 2: a randomised controlled trial (RCT).
The aim of part 1 is to evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the Steady Feet (SF) classes.
Part 1 comprises a pre-post design and qualitative methods. Community instructors' competency levels of class execution will be compared before and after the video-facilitated training. Interviews or focus group discussions will be conducted for community providers, instructors, and community-dwelling older adults to explore the acceptability, appropriateness, feasibility of the exercise video, and to obtain feedback and any recommendations for improvements. This part of the study aims to recruit 30 participants.
The aim of part 2 is to examine the effectiveness of the SF Programme on improving functional outcomes in older adults (aged 60 years and above) with a high risk of falls.
Part 2 comprises an open-label, parallel randomized controlled trial. At least 260 participants (130 intervention and 130 control) with a Short Physical Performance Battery (SPPB) score of 7 to 10, no significant cognitive impairment and vision issues will be recruited to be part of the study. Participants will be randomized to the intervention or control group before the baseline visit and will be followed-up prospectively at the 3rd month, and 6th month. Repeated measures will be performed at the pre-defined time points. The primary outcome of interest is the difference in Short Performance Physical Battery (SPPB) scores between the intervention and control groups at 6 months. Intention to treat analysis will be used. Other outcomes, such as functional assessments, balance confidence, fear of falling, quality of life, healthcare utilisation, and cost, and fall history will also be examined.
- Conditions
- Community-dwelling Older Adults, Fall Risk
- Being tested
- Steady Feet exercise programme, Steady Feet Video
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steady Feet exercise programmeBehavioural
Steady Feet (SF) is a 6-month community-based structured exercise programme aimed at improving physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls.
This exercise programme was developed by Changi General Hospital's physiotherapists and exercise physiologist from evidence found in the literature.
Steady Feet VideoBehavioural
About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Video training | Other | Participants will undergo the following procedures:
Community instructors (involved in the training itself):
* Attend a video-facilitated training
* Be assessed for competency level of class execution before and after the video-facilitated training
* Might need to conduct or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week)
* Might need to participate in one interview/discussion which will last up to 2 hours
Community-dwelling older adult or community providers (individuals involved in the programme implementation but not the training itself):
* Attend or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week)
* Participate in one interview/discussion which will last up to 2 hours Receives: Behavioral: Steady Feet Video |
| Part 2: Exercise Intervention | Experimental | Participants will participate in 6 months of exercises, and be provided with education and advice on how to reduce their risk of falls.
The exercises are divided into 2 phases:
1. The Steady Feet (SF) exercise programme phase. A twice-weekly tailored structured group exercise class will be conducted for 3 months with community instructors and exercise video.
2. A 3 months maintenance exercise phase. A once-weekly structured community group exercise class. Receives: Behavioral: Steady Feet exercise programme |
| Part 2: Control | No intervention | Participants will be provided with the usual education and advice on how to reduce their risk of falls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Changes from pre-competency checklist scores
The competency checklist covers 25 different exercise steps during class execution. Trainers (physiotherapists and exercise physiologists) will indicate a "tick" if the trainee has accurately demonstrated the steps as taught during the video-facilitated training.
Measured: Pre (prior to the video training), post (immediately after the video training)
Part 2: Changes from baseline Short Performance Physical Battery (SPPB) scores
The SPPB is a series of assessments used to evaluate lower extremity function. It consists of 3 types of balance tests (side-by-side stand, semi-tandem stand, tandem stand), a 4 metres gait speed test, and a chair stand test. Scores of each component are summed to form a total SPPB score.
Measured: Baseline, 3rd month, and 6th month
Secondary outcomes (5)
Part 2: Changes from baseline ConfBAL scale scores
A scale that consists of 10 activities. Participants will rate their confidence level in completing each activity without losing their balance. There are 3 ratings available: "not confident = 3 points", "slightly confident = 2 points", and "confident = 1 point". Ratings are summed to form a total score.
Measured: Baseline, 3rd month, and 6th month
Part 2: Changes from baseline Fear of Falling scores
A visual analogue scale, ranging from 0 to 10 that measures the participant's fear of falling, with 0 indicating "not afraid" of falling, and 10 indicating "Extremely" afraid of falling.
Measured: Baseline, 3rd month, and 6th month
Part 2: Changes from baseline EQ-5D-5L scores
A measure of quality of life. It comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Baseline, 3rd month, and 6th month
Part 2: Changes from baseline injurious falls
Participants will be asked questions on their history of falls within the last 6 months, location of falls, and any injuries associated with the falls.
Measured: Baseline, and 6th month
Part 2: Incremental healthcare utilisation and costs over the study period
Participants will be asked questions on their healthcare utilisation, the associated costs, and whether it was fall-related.
Measured: 3rd month, and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start22 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: The study was affected by governmental COVID-19 restrictions in the community, resulting in study implementation delays. The sponsor was unable to extend the funding period further, hence the study was stopped due to a lack of funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Community-dwelling Older AdultsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 of the study is a pre-post non-randomised study with qualitative methods. Part 2 is an open-label, parallel randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Low Shou Lin, Changi General Hospital
- Investigators
- Dr. Low Shou Lin, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801316
- Sponsor's protocol ID
- SFPOV2021
- Status last verified
- Aug 2023
- First submitted
- 1 Mar 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data is not readily available for sharing and may be disclosed on request, at the discretion of the PI and the institution.
Publications
Veronese N, Bolzetta F, Toffanello ED, Zambon S, De Rui M, Perissinotto E, Coin A, Corti MC, Baggio G, Crepaldi G, Sergi G, Manzato E. Association between Short Physical Performance Battery and falls in older people: the Progetto Veneto Anziani Study. Rejuvenation Res. 2014 Jun;17(3):276-84. doi: 10.1089/rej.2013.1491. Epub 2014 Jun 11.
PubMed 24387140Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.
PubMed 21632004Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.
PubMed 28202383Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
PubMed 22972103Lauretani F, Ticinesi A, Gionti L, Prati B, Nouvenne A, Tana C, Meschi T, Maggio M. Short-Physical Performance Battery (SPPB) score is associated with falls in older outpatients. Aging Clin Exp Res. 2019 Oct;31(10):1435-1442. doi: 10.1007/s40520-018-1082-y. Epub 2018 Dec 4.
PubMed 30515724Ong RHS, Nurjono M, Jumala J, Teo RCC, Png GK, Tan PC, Kee MN, Oh HC, Wee MK, Kan KLM, Farhana Binte Rosle L, Lien CTC, Low SL. A community-based single fall prevention exercise intervention for older adults (STEADY FEET): Study protocol for a randomised controlled trial. PLoS One. 2022 Oct 20;17(10):e0276385. doi: 10.1371/journal.pone.0276385. eCollection 2022.
PubMed 36264909
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steady Feet: Proof of Value
- ClinicalTrials.gov ID
- NCT04801316
- Acronym / sponsor ID
- SFPOV2021
- Conditions
- Community-dwelling Older Adults, Fall Risk
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was affected by governmental COVID-19 restrictions in the community, resulting in study implementation delays. The sponsor was unable to extend the funding period further, hence the study was stopped due to a lack of funds.
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Mar 2021 (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.
It is well established that poorer functional performance is associated with falls in older adults. Exercise is shown to be an effective evidence-based intervention in improving functional performance. However, there is a lack of a specially tailored structured exercise intervention in Singapore to address this. In response, a 6-months community-based structured exercise programme, called "Steady Feet" (SF) was developed. It aimed to improve physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls.
Concurrently, COVID-19 led to reduced training and exercise opportunities. There is now a need for alternatives to aid in the training of community instructors, and to carry out exercise programmes for community-dwelling older adults.
Thus, the objectives of this study are to examine (1) evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the SF classes. (2) Evaluate the effects of the SF programme (intervention group) on functional status among older adults (aged 60 years and above), compared with a group of older adults that did not participate in the SF programme (control group).
Detailed description
There will be two parts to this study, part 1: a feasibility study, and part 2: a randomised controlled trial (RCT).
The aim of part 1 is to evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the Steady Feet (SF) classes.
Part 1 comprises a pre-post design and qualitative methods. Community instructors' competency levels of class execution will be compared before and after the video-facilitated training. Interviews or focus group discussions will be conducted for community providers, instructors, and community-dwelling older adults to explore the acceptability, appropriateness, feasibility of the exercise video, and to obtain feedback and any recommendations for improvements. This part of the study aims to recruit 30 participants.
The aim of part 2 is to examine the effectiveness of the SF Programme on improving functional outcomes in older adults (aged 60 years and above) with a high risk of falls.
Part 2 comprises an open-label, parallel randomized controlled trial. At least 260 participants (130 intervention and 130 control) with a Short Physical Performance Battery (SPPB) score of 7 to 10, no significant cognitive impairment and vision issues will be recruited to be part of the study. Participants will be randomized to the intervention or control group before the baseline visit and will be followed-up prospectively at the 3rd month, and 6th month. Repeated measures will be performed at the pre-defined time points. The primary outcome of interest is the difference in Short Performance Physical Battery (SPPB) scores between the intervention and control groups at 6 months. Intention to treat analysis will be used. Other outcomes, such as functional assessments, balance confidence, fear of falling, quality of life, healthcare utilisation, and cost, and fall history will also be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part 1 of the study is a pre-post non-randomised study with qualitative methods. Part 2 is an open-label, parallel randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Video training | Other | Behavioral: Steady Feet VideoParticipants will undergo the following procedures: Community instructors (involved in the training itself): * Attend a video-facilitated training * Be assessed for competency level of class execution before and after the video-facilitated training * Might need to conduct or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week) * Might need to participate in one interview/discussion which will last up to 2 hours Community-dwelling older adult or community providers (individuals involved in the programme implementation but not the training itself): * Attend or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week) * Participate in one interview/discussion which will last up to 2 hours |
| Part 2: Exercise Intervention | Experimental | Behavioral: Steady Feet exercise programmeParticipants will participate in 6 months of exercises, and be provided with education and advice on how to reduce their risk of falls. The exercises are divided into 2 phases: 1. The Steady Feet (SF) exercise programme phase. A twice-weekly tailored structured group exercise class will be conducted for 3 months with community instructors and exercise video. 2. A 3 months maintenance exercise phase. A once-weekly structured community group exercise class. |
| Part 2: Control | No intervention | –Participants will be provided with the usual education and advice on how to reduce their risk of falls. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 years and older
- SPPB score: 7 to 10
- Passes at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- Does not possess significant cognitive impairment (AMT ≥ 5)
Key exclusion criteria (4 listed)
- Male or female aged < 60 years old
- SPPB score of ≥ 11 or ≤ 6
- Did not pass at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- Possess significant cognitive impairment (AMT < 5)
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 |
|---|---|---|
| Steady Feet exercise programmeSteady Feet (SF) is a 6-month community-based structured exercise programme aimed at improving physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls. This exercise programme was developed by Changi General Hospital's physiotherapists and exercise physiologist from evidence found in the literature. | Behavioural | Part 2: Exercise Intervention |
| Steady Feet VideoAbout an hour-long video showcasing the exercise steps of the Steady Feet exercise programme | Behavioural | Part 1: Video training |
Primary outcome
Part 1: Changes from pre-competency checklist scores
Time frame: Pre (prior to the video training), post (immediately after the video training)
The competency checklist covers 25 different exercise steps during class execution. Trainers (physiotherapists and exercise physiologists) will indicate a "tick" if the trainee has accurately demonstrated the steps as taught during the video-facilitated training.
Part 2: Changes from baseline Short Performance Physical Battery (SPPB) scores
Time frame: Baseline, 3rd month, and 6th month
The SPPB is a series of assessments used to evaluate lower extremity function. It consists of 3 types of balance tests (side-by-side stand, semi-tandem stand, tandem stand), a 4 metres gait speed test, and a chair stand test. Scores of each component are summed to form a total SPPB score.
5 secondary outcomes
Part 2: Changes from baseline ConfBAL scale scores
Time frame: Baseline, 3rd month, and 6th month
Part 2: Changes from baseline Fear of Falling scores
Time frame: Baseline, 3rd month, and 6th month
Part 2: Changes from baseline EQ-5D-5L scores
Time frame: Baseline, 3rd month, and 6th month
Part 2: Changes from baseline injurious falls
Time frame: Baseline, and 6th month
Part 2: Incremental healthcare utilisation and costs over the study period
Time frame: 3rd month, and 6th month
Results and safety
The study was stopped early (reason given: The study was affected by governmental COVID-19 restrictions in the community, resulting in study implementation delays. The sponsor was unable to extend the funding period further, hence the study was stopped due to a lack of funds.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 24387140Veronese N, Bolzetta F, Toffanello ED, Zambon S, De Rui M, Perissinotto E, Coin A, Corti MC, Baggio G, Crepaldi G, Sergi G, Manzato E. Association between Short Physical Performance Battery and falls in older people: the Progetto Veneto Anziani Study. Rejuvenation Res. 2014 Jun;17(3):276-84. doi: 10.1089/rej.2013.1491. Epub 2014 Jun 11.
- Background: PubMed 21632004Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.
- Background: PubMed 28202383Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.
- Background: PubMed 22972103Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
- Background: PubMed 30515724Lauretani F, Ticinesi A, Gionti L, Prati B, Nouvenne A, Tana C, Meschi T, Maggio M. Short-Physical Performance Battery (SPPB) score is associated with falls in older outpatients. Aging Clin Exp Res. 2019 Oct;31(10):1435-1442. doi: 10.1007/s40520-018-1082-y. Epub 2018 Dec 4.
- Derived from this study: PubMed 36264909Ong RHS, Nurjono M, Jumala J, Teo RCC, Png GK, Tan PC, Kee MN, Oh HC, Wee MK, Kan KLM, Farhana Binte Rosle L, Lien CTC, Low SL. A community-based single fall prevention exercise intervention for older adults (STEADY FEET): Study protocol for a randomised controlled trial. PLoS One. 2022 Oct 20;17(10):e0276385. doi: 10.1371/journal.pone.0276385. eCollection 2022.
- Individual participant dataSharing planned: No. Research data is not readily available for sharing and may be disclosed on request, at the discretion of the PI and the institution.
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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. This study is not recruiting at the moment.
Dr. Low Shou Lin principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steady Feet exercise programme and Steady Feet Video in people with Community-dwelling Older Adults and Fall Risk, run by Changi General Hospital at 1 site in Singapore.
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 4 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: stopped early, as of the sponsor's last update on 31 Aug 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 Singapore. 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?
The study was stopped early (reason given: The study was affected by governmental COVID-19 restrictions in the community, resulting in study implementation delays. The sponsor was unable to extend the funding period further, hence the study was stopped due to a lack of funds.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Changes from pre-competency checklist scores (time frame: Pre (prior to the video training), post (immediately after the video training)). 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?
On the ClinicalTrials.gov record for NCT04801316, which also lists 6 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 31 Aug 2023.