Healthy AgingNCT05203848
Community Dance Program (CDP) for Older Adults
A study testing Community Dance Intervention in people with Healthy Aging, run by National University of Singapore at 1 site in Singapore.
Trial summary
Objectives: The primary objective of the proposed project is to develop and evaluate a Community Dance Program (CDP) for community-dwelling older adults, which is aimed at promoting physical strength, balance, cognition, mental and psycho-social well-being of the older adults. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Community Dance Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Sep 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 to 85
- Able to understand and communicate in either English or Mandarin
- Able to give consent to participate (have sufficient mental capacity as assessed by the MoCA, with a score of 16 and above)
- Lives within the community setting
- Able to ambulate with minimal assistance
- Able to commit a total of 8 hours over the 8-week period dancing program
Who cannot join
- Medical conditions which result in limitation of dancing
- Older adults with compromised balance and mobility (those who obtained a score of < 5 on the Short Physical Performance Battery (SPPB)
- Severe cognitive or psychiatric disorders
- Severe hearing or vision impairments
- Older adults from the control group who also participate in any other dance group during the intervention period
- Older adults who are uncomfortable with video-recording of the dance sessions
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University of Singapore
Singapore, Singapore, 117599
About this study
Official title: Community Dance Program (CDP) for Older Adults - a Pilot Randomized Control Trial
Objectives:
The primary objective of the proposed project is to develop and evaluate a Community Dance Program (CDP) for community-dwelling older adults, which is aimed at promoting physical strength, balance, cognition, mental and psycho-social well-being of the older adults. A distinctive feature of our project is that a team of researchers across disciplines and community partners will collaborate to develop the program and bring benefits to the older adults living in the community.
Read the detailed description
Research Design:
The research design consists of: (1) Development and implementation of CDP. A pilot cluster randomized controlled trial (RCT) will be conducted to assess the feasibility and primary effect of the program in enhancing the physical, mental, cognitive, and psycho-social health, quality of life, and social support among older adults. (2) Process Evaluation, follow-up focus group discussions will be conducted to assess the acceptability, strengths and limitations of CDP based on the participants' perspectives.
Data Collection and Analysis:
A set of questionnaires will be administered to the older adults. The data will be collected at two time points: baseline and 8-week follow-up. Descriptive statistics, Paired sample t-test, Analysis of Covariance (ANCOVA), General Linear Model (GLM) will be used to examine the difference between the baseline and post-intervention to compare outcome measures from pre to post-implementation. The audio-recorded focused group discussion will be transcribed verbatim respectively. Thematic analysis will be applied to provide an in-depth and rich analysis of the verbatim.
Potential Impact:
CDP will make a positive impact on the older adults' physical, mental and psychological wellbeing. Those impacts will then encourage older adults to live an active life and maximize their social capital within the community. Therefore, CDP promotes the health and wellbeing of the community-dwelling older adults and reduces geriatric-related conditions. The outcome of the study will have tremendous potential to be implemented at a larger scale in the community. Upon completion of the project, the investigators will work closely with community centres and senior activity centres to integrate CDP into their existing programs. CDP could then benefit a larger population given the evidence gathered from this research to enhance the physical, mental and psychological wellbeing of the older adults.
- Conditions
- Healthy Aging
- Being tested
- Community Dance Intervention, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Dance InterventionProcedure or surgery
The main dance instructor for the CDP is Yarra Ileto, who is the Artistic Director for NUS Dance Synergy. Yarra was trained at LASALLE College of the Arts, graduating with a First Class BA (Hons) Dance in 2008. Also, she has experience with crafting and conducting Community Dance Programs (CDP) for Seniors. Yarra will be developing the dance lesson plan and also training selected students from NUS Dance Synergy to guide the seniors during the dance sessions. Older adults will learn and practice the basic steps together for the first few weeks. Then, the student dance instructors will start teaching the dance formation. During each session, participants will need to warm up first to prevent injuries before practicing dance steps. Small group practicing is reserved for older adults to interact with each other. All the participants will do relaxation exercises before ending the session to cool down their bodies and release muscle tensions.
Control groupOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| Dance program intervention | Experimental | The community dance program (CDP) will be developed to promote older adults' physical and mental well-being through dancing. The contents of the program are developed based on the literature review (Rossberg-Gempton \& Poole, 2008). The CDP will be delivered over a period of 8 weeks. Receives: Procedure: Community Dance Intervention |
| Control group | Placebo comparator | There will be no dance intervention among control group participants. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health: Blood pressure
Blood pressure readings will be measured in units of millimeters of mercury (mmHg). Both systolic and diastolic blood pressure values will be recorded before versus after the research intervention to investigate for any significant changes.
Measured: 3 months
Physical health: Body Mass Index (BMI)
BMI was obtained from each participant by measuring his/her height in units of meters and weight in units of kilograms, followed by this formula: kg/m^2. BMI values will be recorded before versus after the research intervention to investigate for any significant changes.
Measured: 3 months
Physical health: Waist and hip circumferences
Waist and hip circumferences of each participant will be obtained in units of centimeters (cm). These values will be recorded before versus after the research intervention to investigate for any significant changes.
Measured: 3 months
Physical health: Short Physical Performance Battery (SPPB)
SPPB is a comprehensive instrument that can be used to measure balance, mobility, and muscle strength in older adults. It consists of balance tests (i.e., side-by-side stand, semi-tandem stand, tandem stand), gait speed tests, and chair stand tests. All values will be recorded in units of seconds and consolidated into the corresponding sum of scores upon successful completion of each test. Higher SPPB scores indicate greater physical capabilities.
Measured: 3 months
Psychosocial health: Subjective Happiness Scale
Subjective Happiness Scale using a "subjectivist" approach to the assessment of happiness, a 4-item measure of global subjective happiness was developed and validated in 14 studies with a total of 2732 participants (Lyubomirsky \& Lepper,1999). A 7-point Likert scale (1 = less happy to 7 = more happy) was used, with higher scores indicating higher subjective happiness.
Measured: 3 months
Cognitive health: Montreal Cognitive Assessment (MoCA)
MoCA was designed as a screening instrument for mild cognitive dysfunction. It assesses various cognitive domains including attention, concentration, executive function, memory, language, visuospatial, and arithmetic skills. The total possible score is 30 points, with the cutoff score of this research study being 16 points. Participants who scored below 16 points will not be included in the research study. A lower MoCA score indicates greater cognitive dysfunction.
Measured: 3 months
Cognitive health: Symbol Digit Modalities Test (SDMT)
SDMT is a screening measure for cerebral dysfunction in adults. A coding key is presented consisting of nine abstract symbols, each paired with a number. The participant is required to scan through the coding key and write down the number corresponding to each symbol, as rapidly as possible. The number of correct answers within the 90-second interval is recorded. The maximum score is 110, with lower scores suggesting cerebral dysfunction.
Measured: 3 months
Cognitive health: The Washington University Dementia Screening Test (AD8)
This scale is also known as "Eight-item Interview to Differentiate Aging and Dementia". The participant was asked to rate changes in his/her ability for each of the items, without attributing causability. The final score is computed by consolidating the sum of the items marked with a change due to cognitive problems, with higher scores indicating higher impairment in cognition.
Measured: 3 months
Quality of Life: WHOQOL-AGE
WHOQOL-AGE is a self-reported questionnaire that was designed specifically to measure quality of life (QoL) in the older adult population (Caballero et al., 2013). It consists of 13 items which are selected from the other versions of WHOQOL instruments (5 items from WHOQOL-OLD and 8 items from EUROHIS-QOL). The items were assessed on a five-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores suggesting higher QoL. WHOQOL-AGE has been evaluated and has shown good reliability and validity (Santos et al., 2018).
Measured: 3 months
Physical health: DNA Methylation (DNAm) Testing
DNA Methylation (DNAm) Testing was conducted by collecting the participants' saliva into a 5 mL polypropylene tube. The participants were instructed to let saliva collect in their mouth and gently push the saliva into a short section of common drinking straw into the tube. Saliva samples were aliquoted into 2 mL polypropylene cryovials, with colour coded lids. De-identified samples will be stored at -80 degrees C. De-identified saliva samples were sent to Muhdo Health Pte Ltd, a UK-based epigenetics testing company for DNA extraction and whole epigenome sequencing, in which the results were shared to the research team.
Measured: 3 months
Physical health: MOXY Near-Infrared Spectroscopy (NIRS) Measurement of muscle oxygenation
MOXY Near-Infrared Spectroscopy (NIRS) Measurement of muscle oxygenation was conducted by attaching a near-infrared spectroscopy probe (Moxy Monitor) on the belly of the vastus lateralis (quadriceps) muscle, midway between the lateral epicondyle and greater trochanter of the femur (DeLorey et al., 2004). This was performed to measure relative muscle oxygenation level before, during contraction, and for up to 1 hour post-exercise. The device measured muscle O2 saturation (SmO2) every 2 seconds throughout the trial, and has been validated and described in detail in a study by Crum et al. (2017). For the present study, the probe was placed on the participant's quadriceps muscle during the SPPB.
Measured: 3 months
Secondary outcomes (3)
Intergenerational communication
Global Perceptions of Intergenerational Communication Scale (GPIC) was developed by McCann \& Giles (2007) to measure perceptions of intergenerational communicative experiences. It consists of 25 items rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree). The first 14 items of the scale assess perceptions of others' communication while the remaining 11 items assess perceptions of one's own communication.
Measured: 3 months
Social support
Social Support Questionnaire 6 items (SSQ6) was developed by Sarason and colleagues (Sarason, Sarason, Shearin \& Pierce,1987). It is used to measure the number of person providing support to an individual and the satisfaction level of the individual who received the support. The scale consists of 6 items. Rating of the items is from 1 (very dissatisfied) to 6 (very satisfied). With excellent Cronbach alphas of 0.90 and 0.93 for 2 respective domains, the scale has been proved to be valid and reliable.
Measured: 3 months
Sociodemographic data
Social-demographic data including age, gender, ethnicity, religion, marital status, employment status, education, social-economic status, source of financial support, household type/ownership, living arrangement and number of children will be collected.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start9 Sep 2021
- Primary completion21 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Lions Befrienders
- Responsible party
- Principal investigator, Vivien Xi WU, PhD, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203848
- Sponsor's protocol ID
- NUS-IRB-2020-808
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu XV, Tam WSW, Yap XY, Zhang J, Mok WYJ, Lim ZX, Goh J. Intergenerational approach of community dance program for older adults in singapore: a feasibility cluster-controlled trial. BMC Geriatr. 2025 Dec 2;26(1):17. doi: 10.1186/s12877-025-06796-7.
PubMed 41327006
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Dance Program (CDP) for Older Adults - a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05203848
- Acronym / sponsor ID
- NUS-IRB-2020-808
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Lions Befrienders
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jan 2022 (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.
Objectives:
The primary objective of the proposed project is to develop and evaluate a Community Dance Program (CDP) for community-dwelling older adults, which is aimed at promoting physical strength, balance, cognition, mental and psycho-social well-being of the older adults. A distinctive feature of our project is that a team of researchers across disciplines and community partners will collaborate to develop the program and bring benefits to the older adults living in the community.
Detailed description
Research Design:
The research design consists of: (1) Development and implementation of CDP. A pilot cluster randomized controlled trial (RCT) will be conducted to assess the feasibility and primary effect of the program in enhancing the physical, mental, cognitive, and psycho-social health, quality of life, and social support among older adults. (2) Process Evaluation, follow-up focus group discussions will be conducted to assess the acceptability, strengths and limitations of CDP based on the participants' perspectives.
Data Collection and Analysis:
A set of questionnaires will be administered to the older adults. The data will be collected at two time points: baseline and 8-week follow-up. Descriptive statistics, Paired sample t-test, Analysis of Covariance (ANCOVA), General Linear Model (GLM) will be used to examine the difference between the baseline and post-intervention to compare outcome measures from pre to post-implementation. The audio-recorded focused group discussion will be transcribed verbatim respectively. Thematic analysis will be applied to provide an in-depth and rich analysis of the verbatim.
Potential Impact:
CDP will make a positive impact on the older adults' physical, mental and psychological wellbeing. Those impacts will then encourage older adults to live an active life and maximize their social capital within the community. Therefore, CDP promotes the health and wellbeing of the community-dwelling older adults and reduces geriatric-related conditions. The outcome of the study will have tremendous potential to be implemented at a larger scale in the community. Upon completion of the project, the investigators will work closely with community centres and senior activity centres to integrate CDP into their existing programs. CDP could then benefit a larger population given the evidence gathered from this research to enhance the physical, mental and psychological wellbeing of the older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance program intervention | Experimental | Procedure: Community Dance InterventionThe community dance program (CDP) will be developed to promote older adults' physical and mental well-being through dancing. The contents of the program are developed based on the literature review (Rossberg-Gempton \& Poole, 2008). The CDP will be delivered over a period of 8 weeks. |
| Control group | Placebo comparator | Other: Control groupThere will be no dance intervention among control group participants. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 55 to 85
- Able to understand and communicate in either English or Mandarin
- Able to give consent to participate (have sufficient mental capacity as assessed by the MoCA, with a score of 16 and above)
- Lives within the community setting
- Able to ambulate with minimal assistance
Key exclusion criteria (6 listed)
- Medical conditions which result in limitation of dancing
- Older adults with compromised balance and mobility (those who obtained a score of < 5 on the Short Physical Performance Battery (SPPB)
- Severe cognitive or psychiatric disorders
- Severe hearing or vision impairments
- Older adults from the control group who also participate in any other dance group during the intervention period
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 |
|---|---|---|
| Community Dance InterventionThe main dance instructor for the CDP is Yarra Ileto, who is the Artistic Director for NUS Dance Synergy. Yarra was trained at LASALLE College of the Arts, graduating with a First Class BA (Hons) Dance in 2008. Also, she has experience with crafting and conducting Community Dance Programs (CDP) for Seniors. Yarra will be developing the dance lesson plan and also training selected students from NUS Dance Synergy to guide the seniors during the dance sessions. Older adults will learn and practice the basic steps together for the first few weeks. Then, the student dance instructors will start teaching the dance formation. During each session, participants will need to warm up first to prevent injuries before practicing dance steps. Small group practicing is reserved for older adults to interact with each other. All the participants will do relaxation exercises before ending the session to cool down their bodies and release muscle tensions. | Procedure or surgery | Dance program intervention |
| Control groupControl group | Other | Control group |
Primary outcome
Physical health: Blood pressure
Time frame: 3 months
Blood pressure readings will be measured in units of millimeters of mercury (mmHg). Both systolic and diastolic blood pressure values will be recorded before versus after the research intervention to investigate for any significant changes.
Physical health: Body Mass Index (BMI)
Time frame: 3 months
BMI was obtained from each participant by measuring his/her height in units of meters and weight in units of kilograms, followed by this formula: kg/m^2. BMI values will be recorded before versus after the research intervention to investigate for any significant changes.
Physical health: Waist and hip circumferences
Time frame: 3 months
Waist and hip circumferences of each participant will be obtained in units of centimeters (cm). These values will be recorded before versus after the research intervention to investigate for any significant changes.
Physical health: Short Physical Performance Battery (SPPB)
Time frame: 3 months
SPPB is a comprehensive instrument that can be used to measure balance, mobility, and muscle strength in older adults. It consists of balance tests (i.e., side-by-side stand, semi-tandem stand, tandem stand), gait speed tests, and chair stand tests. All values will be recorded in units of seconds and consolidated into the corresponding sum of scores upon successful completion of each test. Higher SPPB scores indicate greater physical capabilities.
Psychosocial health: Subjective Happiness Scale
Time frame: 3 months
Subjective Happiness Scale using a "subjectivist" approach to the assessment of happiness, a 4-item measure of global subjective happiness was developed and validated in 14 studies with a total of 2732 participants (Lyubomirsky \& Lepper,1999). A 7-point Likert scale (1 = less happy to 7 = more happy) was used, with higher scores indicating higher subjective happiness.
Cognitive health: Montreal Cognitive Assessment (MoCA)
Time frame: 3 months
MoCA was designed as a screening instrument for mild cognitive dysfunction. It assesses various cognitive domains including attention, concentration, executive function, memory, language, visuospatial, and arithmetic skills. The total possible score is 30 points, with the cutoff score of this research study being 16 points. Participants who scored below 16 points will not be included in the research study. A lower MoCA score indicates greater cognitive dysfunction.
Cognitive health: Symbol Digit Modalities Test (SDMT)
Time frame: 3 months
SDMT is a screening measure for cerebral dysfunction in adults. A coding key is presented consisting of nine abstract symbols, each paired with a number. The participant is required to scan through the coding key and write down the number corresponding to each symbol, as rapidly as possible. The number of correct answers within the 90-second interval is recorded. The maximum score is 110, with lower scores suggesting cerebral dysfunction.
Cognitive health: The Washington University Dementia Screening Test (AD8)
Time frame: 3 months
This scale is also known as "Eight-item Interview to Differentiate Aging and Dementia". The participant was asked to rate changes in his/her ability for each of the items, without attributing causability. The final score is computed by consolidating the sum of the items marked with a change due to cognitive problems, with higher scores indicating higher impairment in cognition.
Quality of Life: WHOQOL-AGE
Time frame: 3 months
WHOQOL-AGE is a self-reported questionnaire that was designed specifically to measure quality of life (QoL) in the older adult population (Caballero et al., 2013). It consists of 13 items which are selected from the other versions of WHOQOL instruments (5 items from WHOQOL-OLD and 8 items from EUROHIS-QOL). The items were assessed on a five-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores suggesting higher QoL. WHOQOL-AGE has been evaluated and has shown good reliability and validity (Santos et al., 2018).
Physical health: DNA Methylation (DNAm) Testing
Time frame: 3 months
DNA Methylation (DNAm) Testing was conducted by collecting the participants' saliva into a 5 mL polypropylene tube. The participants were instructed to let saliva collect in their mouth and gently push the saliva into a short section of common drinking straw into the tube. Saliva samples were aliquoted into 2 mL polypropylene cryovials, with colour coded lids. De-identified samples will be stored at -80 degrees C. De-identified saliva samples were sent to Muhdo Health Pte Ltd, a UK-based epigenetics testing company for DNA extraction and whole epigenome sequencing, in which the results were shared to the research team.
Physical health: MOXY Near-Infrared Spectroscopy (NIRS) Measurement of muscle oxygenation
Time frame: 3 months
MOXY Near-Infrared Spectroscopy (NIRS) Measurement of muscle oxygenation was conducted by attaching a near-infrared spectroscopy probe (Moxy Monitor) on the belly of the vastus lateralis (quadriceps) muscle, midway between the lateral epicondyle and greater trochanter of the femur (DeLorey et al., 2004). This was performed to measure relative muscle oxygenation level before, during contraction, and for up to 1 hour post-exercise. The device measured muscle O2 saturation (SmO2) every 2 seconds throughout the trial, and has been validated and described in detail in a study by Crum et al. (2017). For the present study, the probe was placed on the participant's quadriceps muscle during the SPPB.
3 secondary outcomes
Intergenerational communication
Time frame: 3 months
Social support
Time frame: 3 months
Sociodemographic data
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Derived from this study: PubMed 41327006Wu XV, Tam WSW, Yap XY, Zhang J, Mok WYJ, Lim ZX, Goh J. Intergenerational approach of community dance program for older adults in singapore: a feasibility cluster-controlled trial. BMC Geriatr. 2025 Dec 2;26(1):17. doi: 10.1186/s12877-025-06796-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Dance Intervention in people with Healthy Aging, run by National University of Singapore 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 30 Oct 2024. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical health: Blood pressure (time frame: 3 months). The study lists 11 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 NCT05203848, which also lists 1 linked publication.
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 30 Oct 2024.