Exercise TrainingNCT05068271
Multi-Domain Exercise and Memory in Adults Relative to ApoE Genotype: A fMRI Study
A study testing Multi-Domain Exercise Program in people with Exercise Training and Executive Function, run by National Taiwan Normal University at 2 sites in Taiwan.
Trial summary
The current project utilizes a single-blinded, double arm, 6-month randomized controlled trial to assess the effects of a multi-domain exercise program on memory performance, as well as cortical activities during the memory tasks in cognitively intact adults (i.e., 45-70 years). Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Executive Function, Aging
- What is being tested?
- Multi-Domain Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 12 Apr 2022to Sep 2025
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal or corrected-to-normal vision
- Able to speak and read Chinese
- Scores of Mini-Mental Status Examination >= 25
- Physical Activity Readiness Questionnaire score < 0
- Able to conduct the exercise with moderate intensity
- Meet the criteria to undergo magnetic resonance imaging
- Provide informed consent
Who cannot join
- Diagnosed or self-reported cognitive problems (e.g., mild cognitive impairment or dementia)
- Diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
- Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
- Diagnosed or self-reported neurodegenerative disease (e.g., Alzheimer's disease and other dementias, Parkinson's disease (PD) and PD-related disorders, Huntington's disease)
- History of alcohol or drug abuse
- History of chemotherapy
Show all 11Show fewer
- Traveling consecutively for three weeks or more during the study
- Unwillingness to be randomized to one of the two groups
- Currently participating in another study trial
- Exclusion Criteria for functional magnetic resonance images (fMRI):
- Participants will be excluded if s/he has a contraindication to fMRI scanning, such as aneurysm clip, implanted neural stimulator, cochlear implant, any implanted device, cardiac pacemaker. To ensure volunteers are eligible for the current project, they will be asked to fill out a questionnaire to inform whether they have conditions (e.g. paralyzed hemidiaphragm) or present unnecessary risks (e.g., pregnancy) during the recruitment period.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Yu-Kai Chang
Taipei, 106
Yu-Kai Chang, PhD, +886277493220, yukaichangnew@gmail.com
- Recruiting
National Taiwan Normal University
Taipei, 162
Yu-Kai Chang, +886277493220, yukaichangnew@gmail.com
About this study
Official title: Effects of Multi-Domain Exercise Intervention on Memory Performance in Healthy Adults With and Without ApoE e4 Allele: A fMRI Study
The current project utilizes a single-blinded, double arm, 6-month randomized controlled trial to assess the effects of a multi-domain exercise program on memory performance, as well as cortical activities during the memory tasks in cognitively intact adults (i.e., 45-70 years). In addition, the potential moderator role of apolipoprotein epsilon-4 (ApoE e4) status and the mediator role of the brain-derived neurotrophic factor (BDNF) will be explored.
Read the detailed description
Aging has been adversely associated with the deterioration of cognitive and brain functions. Most research on the effects of regular exercise on cognitive and brain functions has been focused on exercise programs with a single mode of exercise. Studies focusing on the effects of exercise programs with multi-domains on cognitive function and cortical functionality are sparse in late-middle-aged and older adults. In addition, while growing evidence has revealed the beneficial effects of regular exercise on cognitive function, scientific evidence regarding the effects of multi-domain exercise programs on cognitive function and brain function in late-middle-aged and older adults who are with or without the genetic risk for Alzheimer's disease (AD) is scarce. Lastly, the potential mediator role of the brain-derived neurotrophic factor (BDNF) in individuals is required to be explored.
In the current study, a single-blinded, double arm, 6-month randomized controlled trial has been utilized to assess the effects of a multi-domain exercise program containing multiple physical fitness components, meditation, and social interaction on memory, as well as cortical functionalities during the memory tasks in cognitively intact adults (i.e., 45-70 years). Specifically, the project aims to examine: (1) the causal links between a multi-domain exercise program composed of various physical fitness components, meditation, and social interaction against a control group on the memory performance in cognitively intact adults aged between 45 and 70 years with or without a genetic risk for AD, (2) the cortical functionality through functional images collected through a series of functional magnetic resonance images (fMRI), and (3) the potential influence of apolipoprotein epsilon-4 (ApoE e4) and BDNF on the effects of exercise.
One hundred eligible individuals will participate in the current study and will be randomly assigned into either the 6-month multi-domain exercise group (exercise group) or the online educational course group (control group).
All participants' physical fitness, cognitive function, and cortical functionalities via fMRI scanning will be assessed at the Baseline (Baseline-Assessments) and at the cessation of the 6-month intervention (Post-Assessments). The potential moderating role of ApoE genotypes and the mediation role of BDNF will be explored. Participation in this study will take approximately 7 months.
- Conditions
- Exercise Training, Executive Function, Aging
- Being tested
- Multi-Domain Exercise Program, Control Group
- Keywords
- multiple fitness, meditation, mindfulness, Apolipoprotein E, aging, magnetic resonance images, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Domain Exercise ProgramBehavioural
The multi-domain exercise consisted of the main exercise (e.g., aerobic exercise, resistance exercise, flexibility training, and coordinative exercise), social interaction, and meditation. Participants are encouraged to engage in 150 min exercise per week consisting of one 90-min on-site session and multiple online sessions for 6 months.
Control GroupBehavioural
The "usual physical activity group," as the control group, is informed to maintain their lifestyles. In addition, participants are invited to attend one 60-min online educational course per week. The logs of physical activity behavior will be obtained from the participants once per month during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Domain Exercise Program | Experimental | Time: 6 months, total of 150 min of exercise per week.
Intervention: aerobic training, muscular fitness training, balance, flexibility, meditation, and social interaction. Receives: Behavioral: Multi-Domain Exercise Program |
| Control Group | Other | Time: 6 months, total of 60 min of online educational course per week.
Intervention: educational materials relating to the effects of exercise on cognitive function and aging-related cognitive decline. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional MRI indices
Functional MRI assessments will be conducted at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment) to measure participants' brain functionalities. Changes in functional MRI indices between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 60 min each at the Baseline-Assessment and at the Post-Assessment
Changes in working memory performance: N-back working memory task
Working memory performance will be assessed using the computerized n-back working memory task at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). A total of 6 blocks with 108 trials (18 trials each block) will be utilized in the current study. Changes in working memory performance between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 30 min assessment time at the Baseline-Assessment and at the Post-Assessment
Changes in episodic memory performance: Relational and item-specific encoding and recognition test
Episodic memory performance will be assessed using the relational and item-specific encoding and recognition test at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Changes in episodic memory performance between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 30 min each session at the Baseline-Assessment and at the Post-Assessment
Secondary outcomes (10)
ApoE genotype
Based on the genetic biomarkers (rs429358 and rs7412), participants' ApoE genotype will be determined.
Measured: 5 min at the Baseline Assessment
Changes in blood neurotrophic marker: Brain-derived neurotrophic factor (BDNF)
A 6 mL serum sample will be drawn from the antecubital vein at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment) to determine the concentration of BDNF. Changes in BDNF levels between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 5 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in aerobic fitness
Participants' aerobic fitness will be estimated using the submaximal cycle ergometer test at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Changes in aerobic fitness between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 20 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in muscular fitness
Muscular fitness will be assessed using either the push-up test/30sec or the chair stand test/30sec at the baseline (Baseline-Assessment) and the end of the 6-month intervention (Post-Assessment). A higher number completed indicated a better level of muscular fitness. Changes in muscular fitness between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 15 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in flexibility
Flexibility will be assessed using the sit-and-reach test at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Further distance indicates better lower back and hip joint flexibility. Changes in flexibility between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 15 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in body composition
The body composition (e.g., body water, body fat, skeletal muscle mass, body mass index, and percentage of body fat) will be assessed simultaneously using a body composition analyzer (ACCUNIQ BC380 Body Composition Analysis, SELVAS Healthcare Inc., Korea) at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Changes in body composition between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 15 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in mindfulness
Levels of mindfulness will be assessed using the 15-items (1-6 Likert scale) WHOQOL-OLD-Taiwan Chinese version of the Mindful Attention Awareness Scale questionnaire at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Higher scores are associated with higher dispositional mindfulness. Changes in mindfulness levels between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in sleep quality
Sleep quality is assessed by the Pittsburgh Sleep Quality Index. The questionnaire consists of 9 questions. Lower scores are associated with better sleep quality. Changes in sleep quality between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in depression
Depression level is assessed by the Chinese version of the Geriatric Depression Scale (GDS-15). The questionnaire consists of 15 'Yes/No' items. The total scores between 5 and 9 indicate mild symptoms, and a score of 10 and above indicates moderate symptoms. Changes in depression levels between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in health-related quality of life
Health-related quality of life is assessed by the 24-items (1-5 Likert scale) WHOQOL-OLD-Taiwan. The higher total scores indicate better quality of life. Changes in health-related quality of life between the Baseline-Assessment and Post-Assessment will be assessed.
Measured: 10 min each at the Baseline-Assessment and at the Post-Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start12 Apr 2022
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
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 Exercise TrainingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Kai Chang, National Taiwan Normal University
- Investigators
- Yu-Kai Chang, PhD, Principal investigator, Department of Physical Education and Sport Sciences, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068271
- Sponsor's protocol ID
- PACNL_WEBFIT: Memory & fMRI
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang YK, Erickson KI, Aghjayan SL, Chen FT, Li RH, Shih JR, Chang SH, Huang CM, Chu CH. The multi-domain exercise intervention for memory and brain function in late middle-aged and older adults at risk for Alzheimer's disease: A protocol for Western-Eastern Brain Fitness Integration Training trial. Front Aging Neurosci. 2022 Aug 18;14:929789. doi: 10.3389/fnagi.2022.929789. eCollection 2022.
PubMed 36062144
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi-Domain Exercise Intervention on Memory Performance in Healthy Adults With and Without ApoE e4 Allele: A fMRI Study
- ClinicalTrials.gov ID
- NCT05068271
- Acronym / sponsor ID
- PACNL_WEBFIT: Memory & fMRI
- Conditions
- Exercise Training, Executive Function, Aging
- Keywords
- multiple fitness, meditation, mindfulness, Apolipoprotein E, aging, magnetic resonance images, memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Oct 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.
The current project utilizes a single-blinded, double arm, 6-month randomized controlled trial to assess the effects of a multi-domain exercise program on memory performance, as well as cortical activities during the memory tasks in cognitively intact adults (i.e., 45-70 years). In addition, the potential moderator role of apolipoprotein epsilon-4 (ApoE e4) status and the mediator role of the brain-derived neurotrophic factor (BDNF) will be explored.
Detailed description
Aging has been adversely associated with the deterioration of cognitive and brain functions. Most research on the effects of regular exercise on cognitive and brain functions has been focused on exercise programs with a single mode of exercise. Studies focusing on the effects of exercise programs with multi-domains on cognitive function and cortical functionality are sparse in late-middle-aged and older adults. In addition, while growing evidence has revealed the beneficial effects of regular exercise on cognitive function, scientific evidence regarding the effects of multi-domain exercise programs on cognitive function and brain function in late-middle-aged and older adults who are with or without the genetic risk for Alzheimer's disease (AD) is scarce. Lastly, the potential mediator role of the brain-derived neurotrophic factor (BDNF) in individuals is required to be explored.
In the current study, a single-blinded, double arm, 6-month randomized controlled trial has been utilized to assess the effects of a multi-domain exercise program containing multiple physical fitness components, meditation, and social interaction on memory, as well as cortical functionalities during the memory tasks in cognitively intact adults (i.e., 45-70 years). Specifically, the project aims to examine: (1) the causal links between a multi-domain exercise program composed of various physical fitness components, meditation, and social interaction against a control group on the memory performance in cognitively intact adults aged between 45 and 70 years with or without a genetic risk for AD, (2) the cortical functionality through functional images collected through a series of functional magnetic resonance images (fMRI), and (3) the potential influence of apolipoprotein epsilon-4 (ApoE e4) and BDNF on the effects of exercise.
One hundred eligible individuals will participate in the current study and will be randomly assigned into either the 6-month multi-domain exercise group (exercise group) or the online educational course group (control group).
All participants' physical fitness, cognitive function, and cortical functionalities via fMRI scanning will be assessed at the Baseline (Baseline-Assessments) and at the cessation of the 6-month intervention (Post-Assessments). The potential moderating role of ApoE genotypes and the mediation role of BDNF will be explored. Participation in this study will take approximately 7 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Domain Exercise Program | Experimental | Behavioral: Multi-Domain Exercise ProgramTime: 6 months, total of 150 min of exercise per week. Intervention: aerobic training, muscular fitness training, balance, flexibility, meditation, and social interaction. |
| Control Group | Other | Behavioral: Control GroupTime: 6 months, total of 60 min of online educational course per week. Intervention: educational materials relating to the effects of exercise on cognitive function and aging-related cognitive decline. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal or corrected-to-normal vision
- Able to speak and read Chinese
- Scores of Mini-Mental Status Examination >= 25
- Physical Activity Readiness Questionnaire score < 0
- Able to conduct the exercise with moderate intensity
Key exclusion criteria (11 listed)
- Diagnosed or self-reported cognitive problems (e.g., mild cognitive impairment or dementia)
- Diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
- Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
- Diagnosed or self-reported neurodegenerative disease (e.g., Alzheimer's disease and other dementias, Parkinson's disease (PD) and PD-related disorders, Huntington's disease)
- History of alcohol or drug abuse
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 |
|---|---|---|
| Multi-Domain Exercise ProgramThe multi-domain exercise consisted of the main exercise (e.g., aerobic exercise, resistance exercise, flexibility training, and coordinative exercise), social interaction, and meditation. Participants are encouraged to engage in 150 min exercise per week consisting of one 90-min on-site session and multiple online sessions for 6 months. | Behavioural | Multi-Domain Exercise Program |
| Control GroupThe "usual physical activity group," as the control group, is informed to maintain their lifestyles. In addition, participants are invited to attend one 60-min online educational course per week. The logs of physical activity behavior will be obtained from the participants once per month during the intervention period. | Behavioural | Control Group |
Primary outcome
Changes in functional MRI indices
Time frame: 60 min each at the Baseline-Assessment and at the Post-Assessment
Functional MRI assessments will be conducted at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment) to measure participants' brain functionalities. Changes in functional MRI indices between the Baseline-Assessment and Post-Assessment will be assessed.
Changes in working memory performance: N-back working memory task
Time frame: 30 min assessment time at the Baseline-Assessment and at the Post-Assessment
Working memory performance will be assessed using the computerized n-back working memory task at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). A total of 6 blocks with 108 trials (18 trials each block) will be utilized in the current study. Changes in working memory performance between the Baseline-Assessment and Post-Assessment will be assessed.
Changes in episodic memory performance: Relational and item-specific encoding and recognition test
Time frame: 30 min each session at the Baseline-Assessment and at the Post-Assessment
Episodic memory performance will be assessed using the relational and item-specific encoding and recognition test at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Changes in episodic memory performance between the Baseline-Assessment and Post-Assessment will be assessed.
10 secondary outcomes
ApoE genotype
Time frame: 5 min at the Baseline Assessment
Changes in blood neurotrophic marker: Brain-derived neurotrophic factor (BDNF)
Time frame: 5 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in aerobic fitness
Time frame: 20 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in muscular fitness
Time frame: 15 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in flexibility
Time frame: 15 min each at the Baseline-Assessment and at the Post-Assessment
Physical fitness measurements: Changes in body composition
Time frame: 15 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in mindfulness
Time frame: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in sleep quality
Time frame: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in depression
Time frame: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in health-related quality of life
Time frame: 10 min each at the Baseline-Assessment and at the Post-Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 36062144Chang YK, Erickson KI, Aghjayan SL, Chen FT, Li RH, Shih JR, Chang SH, Huang CM, Chu CH. The multi-domain exercise intervention for memory and brain function in late middle-aged and older adults at risk for Alzheimer's disease: A protocol for Western-Eastern Brain Fitness Integration Training trial. Front Aging Neurosci. 2022 Aug 18;14:929789. doi: 10.3389/fnagi.2022.929789. eCollection 2022.
- 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.
Yu-Kai Chang, PhD principal investigator
Department of Physical Education and Sport Sciences, National Taiwan Normal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Domain Exercise Program in people with Exercise Training and Executive Function, run by National Taiwan Normal University at 2 sites 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 7 inclusion and 11 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yu-Kai Chang, PhD (+886277493220, yukaichangnew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional MRI indices (time frame: 60 min each at the Baseline-Assessment and at the Post-Assessment). The study lists 3 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 NCT05068271, 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 27 Nov 2023.