Severe Mental DisorderHEPPE-PSMINCT06069739
Health Education Programme Through Physical Exercise for People With Severe Mental Disorders
A study testing Guided physical activity and Standard physical activity in people with Severe Mental Disorder and Obesity, run by Fundación para la Investigación del Hospital Clínico de Valencia.
Trial summary
The goal of this clinical trial is to [learn about, test, compare etc.] in individuals with severe mental disorders and obesity comorbid. The main question[s] it aims to answer are: Are inflammatory activity, oxidative and vascular damage and metabolic mechanisms, as well as neurocognitive and functional performance… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Mental Disorder, Obesity
- What is being tested?
- Guided physical activity and Standard physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 30 Jun 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MDD, BD and SZ were diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM-5 (APA, 2014).
- Participants with MDD and BD should meet the remission criteria (Tohen et al., 2009) of an acute affective episode, defined as Young Mania Rating Scale (YMRS) score ≤ 6 and Hamilton Rating Scale for Depression (HRSD) score ≤ 8, and individuals with SZ had to be clinically stable, defined as Positive and Negative Syndrome Scale (PANSS) score ≤ 36.
- The comorbid OB diagnosis was based on World Health Organization (WHO) criteria.
- Ability to understand study procedures and willingness to give written consent was required for participation.
- For recruitment as HC
- Absence of physical illness
Show all 9Show fewer
- Absence of pharmacological treatments
- Absence of family history of psychiatric disorders in first-degree relatives were required.
- Ability to understand study procedures and willingness to give written consent was required for participation.
Who cannot join
- current hospitalization
- documented cognitive impairment not secondary to psychiatric disorder (intellectual disability or major neurocognitive disorder, i.e. dementia)
- disability or inability that prevented understanding of the protocol
- current substance use disorders (except for nicotine)
- pregnancy
- intake of steroids
Show all 13Show fewer
- corticosteroids, antioxidants, antibiotics, and immunologic therapies
- fever over 38°C
- history of vaccination within 4 weeks of the evaluation
- medical contraindications for exercise
- body mass index ≥ 40
- diastolic/systolic blood pressure ≥ 140/90
- resting heart rate ≥ 100.
About this study
Official title: Development and Evaluation of a Health Education Programme Through Physical Exercise for the Development of Autonomous Physical Activity Habits in People With Severe Mental Disorders
The goal of this clinical trial is to [learn about, test, compare etc.] in individuals with severe mental disorders and obesity comorbid.
The main question[s] it aims to answer are:
Read more
- Are inflammatory activity, oxidative and vascular damage and metabolic mechanisms, as well as neurocognitive and functional performance, related to different physical exercise interventions?
- Do inflammatory, oxidative stress and cardiometabolic biomarkers predict neurocognitive improvement after physical activity training?
Participants will guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG).
If there is a comparison group: Researchers will compare GPAG and SPAG to see if inflammatory, oxidative stress, and cardio-metabolic biomarkers improve neurocognitive performance after physical activity training
Read the detailed description
The psychiatric disorders and obesity comorbidity is related to neurocognitive impairment and inflammation. Exercise is crucial to improve and maintain healthy lifestyles. This randomized controlled trial tested the efficacy of aerobic exercise as promoter of neurocognitive improvement across psychiatric disorders and OB comorbid. Participants (n=29) received brief healthy lifestyle counseling and were randomized to 12 weeks of guided-exercise of moderate intensity and frequency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG) (n=10) or 12 weeks of exercise standard physical activity without guided and incentives; standard physical activity group (SPAG) (n=19). Peripheral blood biomarkers of inflammation, oxidative stress, vascular mechanisms and metabolic activity, as well as neurocognitive and functional performance were assessed twice over after and before treatment. Mixed one-way analysis of variance and linear regression analyses were performed.
- Conditions
- Severe Mental Disorder, Obesity
- Being tested
- Guided physical activity, Standard physical activity
- Keywords
- Exercise, Neurocognition, Inflammation, Oxidative stress, Vascular damage, Metabolic activity, Mental illnesses, Obesity
- Medical subject headings
- Mental Disorders, Obesity, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided physical activityBehavioural
To achieve the European guidelines of 150 minutes by week of moderate intensity physical activity, participants randomized to the GPAG condition were prescribed three 60 minutes exercise sessions (five minutes of warm-up and five minutes of cool-down for a total of sixty minutes per session) per week for 12 weeks. Exercise consisted of brisk walking in urban and rural open spaces during which heart rate monitors were worn and participants were instructed to stay within their moderate intensity range. The incentives were different proposals for specific exercises to train the different musculoskeletal areas more comprehensively. Autonomous exercise was monitored offside the sessions through a series of weekly checkpoints.
Standard physical activityBehavioural
Participants randomised to the SPAG performed their usual daily activities and continued with their daily routine.
Both conditions were matched for duration of physical activity. Participants in both conditions were required to attend three on-site sessions by week over 12 weeks that served as checkpoints. Moreover, both conditions were provided with brief healthy lifestyle counseling at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Guided physical activity group | Experimental | Guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist. Receives: Behavioral: Guided physical activity |
| Standard physical activity group | Active comparator | Standard physical activity without guided and incentives. Receives: Behavioral: Standard physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal learning and memory
Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
Measured: 4 months
Cognitive flexibility
Wisconsin Card Sorting Test The higher scores mean a better outcome.
Measured: 4 months
Verbal fluency
Animal naming test for phonemic and semantic fluency. The higher scores mean a better outcome.
Measured: 4 months
Working memory
Trail Making Test The higher scores mean a better outcome.
Measured: 4 months
Short-term memory
Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
Measured: 4 months
Visual memory
Rey-Osterrieth Complex Figure Test figure two minutes after the copy and 20 minutes after the copy.
The higher scores mean a better outcome.
Measured: 4 months
Processing speed
Stroop Color and Word test color/word subtest The higher scores mean a better outcome.
Measured: 4 months
Functional Assessment Short Test
Functional performance. The higher scores mean a better outcome.
Measured: 4 months
Short Form-36 Health Survey questionnaire
Quality of life. The higher scores mean a better outcome.
Measured: 4 months
World Health Organization Quality of Life brief scale
Quality of life. The higher scores mean a better outcome.
Measured: 4 months
Inflammatory markers
Serum cytokine concentrations were determined using Luminex® X-MAP technology (Luminex Corp., Austin, TX, USA) based on flow cytometry. Sample processing and data analysis were performed according to the manufacturer's instructions. (Behring Nephelometer II, Dade Behring, Inc., Newark, DE, USA)..
Measured: 4 months
Oxidative stress markers
Oxidative stress in leukocytes was evaluated using fluorimetry techniques with a fluoroscan (Synergy MX). In total, 100 000 cells were plated in each well of 96-well plates and incubated for 30 min at 37 °C with the corresponding fluorochromes, as follows: dichlorofluorescein diacetate to measure reactive oxygen species (ROS) production (485 nm excitation, 535 nm emission), MitoSOX to measure mitochondrial ROS (mROS) (510 nm excitation, 580 nm emission), tetramethylrodamin methyl ester to assess mitochondrial membrane potential (552 nm excitation, 574 nm emission), nonylacridin orange mitochondrial mass (495 nm excitation, 519 nm emission), and 5-chloromethylfluorescein diacetate to measure intracellular glutathione (492 nm excitation, 517 nm emission). The monocyte cell line U-937 was used as an internal control to avoid potential fluctuations in fluorescence over time.
Measured: 4 months
Adhesion molecules markers
Serum lipid peroxidation levels were measured using a commercial thiobarbituric acid reactive substances (TBARS) kit according to the manufacturer's instructions (Olympus, Hamburg, Germany). A Luminex 200 flow analyzer system (Austin, TX, USA) was employed to analyze adhesion molecules in serum. To measure immunological markers, citrated blood samples were incubated with dextran (3%) for 45 min to isolate human polymorphonuclear leukocytes (PMNs). The supernatant was layered over Ficoll-Hypaque (GE Healthcare, Barcelona, Spain) and centrifuged for 25 min at room temperature at 650g. Lysis buffer was added to the remaining erythrocytes in the pellet, which were incubated at room temperature for 5 min and then spun at 240g for 5 min. PMNs were rinsed twice and resuspended at 37 ℃ in Hanks' balanced salt solution (Sigma Aldrich, MO). Scepter 2.0 cell counters (Millipore, MA, USA) was employed to count cells
Measured: 4 months
Metabolic markers
Under aseptic conditions, fasting venous blood samples were collected between 8 and 9 am to measure.
Measured: 4 months
Maximum heart rate
Measured with a watch-shaped device that was worn on the wrist and captured the beats per minute.
Measured: 4 months
Systolic pressure/diastolic pressure
Measured on the right arm using an automatic sphygmomanometer with participants in the sitting position after resting for 5 minutes.
Measured: 4 months
Waist circumference
Measured in the standing position at the end of normal expiration and at the midway between the inferior costal margin and the superior border of the iliac crest.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Mar 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants were randomly assigned in a 1:1 ratio to a 12-week program of either; (a) guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG). Both groups followed the same randomized recruitment procedure, data collection and follow-up. All treatment sessions were conducted from March to June 2016. To maintain the rigor of the research, possible risks that could question the internal and external validity of the study results were identified and strategies were proposed to eliminate them.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Tabarés-Seisdedos, Principal investigator, Consorcio Centro de Investigación Biomédica en Red (CIBER)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069739
- Sponsor's protocol ID
- Physical exercise programme
- Acronym
- HEPPE-PSMI
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Health Education Programme Through Physical Exercise for the Development of Autonomous Physical Activity Habits in People With Severe Mental Disorders
- ClinicalTrials.gov ID
- NCT06069739
- Acronym / sponsor ID
- HEPPE-PSMI / Physical exercise programme
- Conditions
- Severe Mental Disorder, Obesity
- Keywords
- Exercise, Neurocognition, Inflammation, Oxidative stress, Vascular damage, Metabolic activity, Mental illnesses, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 6 Oct 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.
The goal of this clinical trial is to [learn about, test, compare etc.] in individuals with severe mental disorders and obesity comorbid.
The main question[s] it aims to answer are:
- Are inflammatory activity, oxidative and vascular damage and metabolic mechanisms, as well as neurocognitive and functional performance, related to different physical exercise interventions?
- Do inflammatory, oxidative stress and cardiometabolic biomarkers predict neurocognitive improvement after physical activity training?
Participants will guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG).
If there is a comparison group: Researchers will compare GPAG and SPAG to see if inflammatory, oxidative stress, and cardio-metabolic biomarkers improve neurocognitive performance after physical activity training
Detailed description
The psychiatric disorders and obesity comorbidity is related to neurocognitive impairment and inflammation. Exercise is crucial to improve and maintain healthy lifestyles. This randomized controlled trial tested the efficacy of aerobic exercise as promoter of neurocognitive improvement across psychiatric disorders and OB comorbid. Participants (n=29) received brief healthy lifestyle counseling and were randomized to 12 weeks of guided-exercise of moderate intensity and frequency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG) (n=10) or 12 weeks of exercise standard physical activity without guided and incentives; standard physical activity group (SPAG) (n=19). Peripheral blood biomarkers of inflammation, oxidative stress, vascular mechanisms and metabolic activity, as well as neurocognitive and functional performance were assessed twice over after and before treatment. Mixed one-way analysis of variance and linear regression analyses were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible participants were randomly assigned in a 1:1 ratio to a 12-week program of either; (a) guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG). Both groups followed the same randomized recruitment procedure, data collection and follow-up. All treatment sessions were conducted from March to June 2016. To maintain the rigor of the research, possible risks that could question the internal and external validity of the study results were identified and strategies were proposed to eliminate them.
| Arm | Type | Receives |
|---|---|---|
| Guided physical activity group | Experimental | Behavioral: Guided physical activityGuided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist. |
| Standard physical activity group | Active comparator | Behavioral: Standard physical activityStandard physical activity without guided and incentives. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- MDD, BD and SZ were diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM-5 (APA, 2014).
- Participants with MDD and BD should meet the remission criteria (Tohen et al., 2009) of an acute affective episode, defined as Young Mania Rating Scale (YMRS) score ≤ 6 and Hamilton Rating Scale for Depression (HRSD) score ≤ 8, and individuals with SZ had to be clinically stable, defined as Positive and Negative Syndrome Scale (PANSS) score ≤ 36.
- The comorbid OB diagnosis was based on World Health Organization (WHO) criteria.
- Ability to understand study procedures and willingness to give written consent was required for participation.
- For recruitment as HC
Key exclusion criteria (13 listed)
- current hospitalization
- documented cognitive impairment not secondary to psychiatric disorder (intellectual disability or major neurocognitive disorder, i.e. dementia)
- disability or inability that prevented understanding of the protocol
- current substance use disorders (except for nicotine)
- pregnancy
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 |
|---|---|---|
| Guided physical activityTo achieve the European guidelines of 150 minutes by week of moderate intensity physical activity, participants randomized to the GPAG condition were prescribed three 60 minutes exercise sessions (five minutes of warm-up and five minutes of cool-down for a total of sixty minutes per session) per week for 12 weeks. Exercise consisted of brisk walking in urban and rural open spaces during which heart rate monitors were worn and participants were instructed to stay within their moderate intensity range. The incentives were different proposals for specific exercises to train the different musculoskeletal areas more comprehensively. Autonomous exercise was monitored offside the sessions through a series of weekly checkpoints. | Behavioural | Guided physical activity group |
| Standard physical activityParticipants randomised to the SPAG performed their usual daily activities and continued with their daily routine. Both conditions were matched for duration of physical activity. Participants in both conditions were required to attend three on-site sessions by week over 12 weeks that served as checkpoints. Moreover, both conditions were provided with brief healthy lifestyle counseling at baseline. | Behavioural | Standard physical activity group |
Primary outcome
Verbal learning and memory
Time frame: 4 months
Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
Cognitive flexibility
Time frame: 4 months
Wisconsin Card Sorting Test The higher scores mean a better outcome.
Verbal fluency
Time frame: 4 months
Animal naming test for phonemic and semantic fluency. The higher scores mean a better outcome.
Working memory
Time frame: 4 months
Trail Making Test The higher scores mean a better outcome.
Short-term memory
Time frame: 4 months
Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
Visual memory
Time frame: 4 months
Rey-Osterrieth Complex Figure Test figure two minutes after the copy and 20 minutes after the copy. The higher scores mean a better outcome.
Processing speed
Time frame: 4 months
Stroop Color and Word test color/word subtest The higher scores mean a better outcome.
Functional Assessment Short Test
Time frame: 4 months
Functional performance. The higher scores mean a better outcome.
Short Form-36 Health Survey questionnaire
Time frame: 4 months
Quality of life. The higher scores mean a better outcome.
World Health Organization Quality of Life brief scale
Time frame: 4 months
Quality of life. The higher scores mean a better outcome.
Inflammatory markers
Time frame: 4 months
Serum cytokine concentrations were determined using Luminex® X-MAP technology (Luminex Corp., Austin, TX, USA) based on flow cytometry. Sample processing and data analysis were performed according to the manufacturer's instructions. (Behring Nephelometer II, Dade Behring, Inc., Newark, DE, USA)..
Oxidative stress markers
Time frame: 4 months
Oxidative stress in leukocytes was evaluated using fluorimetry techniques with a fluoroscan (Synergy MX). In total, 100 000 cells were plated in each well of 96-well plates and incubated for 30 min at 37 °C with the corresponding fluorochromes, as follows: dichlorofluorescein diacetate to measure reactive oxygen species (ROS) production (485 nm excitation, 535 nm emission), MitoSOX to measure mitochondrial ROS (mROS) (510 nm excitation, 580 nm emission), tetramethylrodamin methyl ester to assess mitochondrial membrane potential (552 nm excitation, 574 nm emission), nonylacridin orange mitochondrial mass (495 nm excitation, 519 nm emission), and 5-chloromethylfluorescein diacetate to measure intracellular glutathione (492 nm excitation, 517 nm emission). The monocyte cell line U-937 was used as an internal control to avoid potential fluctuations in fluorescence over time.
Adhesion molecules markers
Time frame: 4 months
Serum lipid peroxidation levels were measured using a commercial thiobarbituric acid reactive substances (TBARS) kit according to the manufacturer's instructions (Olympus, Hamburg, Germany). A Luminex 200 flow analyzer system (Austin, TX, USA) was employed to analyze adhesion molecules in serum. To measure immunological markers, citrated blood samples were incubated with dextran (3%) for 45 min to isolate human polymorphonuclear leukocytes (PMNs). The supernatant was layered over Ficoll-Hypaque (GE Healthcare, Barcelona, Spain) and centrifuged for 25 min at room temperature at 650g. Lysis buffer was added to the remaining erythrocytes in the pellet, which were incubated at room temperature for 5 min and then spun at 240g for 5 min. PMNs were rinsed twice and resuspended at 37 ℃ in Hanks' balanced salt solution (Sigma Aldrich, MO). Scepter 2.0 cell counters (Millipore, MA, USA) was employed to count cells
Metabolic markers
Time frame: 4 months
Under aseptic conditions, fasting venous blood samples were collected between 8 and 9 am to measure.
Maximum heart rate
Time frame: 4 months
Measured with a watch-shaped device that was worn on the wrist and captured the beats per minute.
Systolic pressure/diastolic pressure
Time frame: 4 months
Measured on the right arm using an automatic sphygmomanometer with participants in the sitting position after resting for 5 minutes.
Waist circumference
Time frame: 4 months
Measured in the standing position at the end of normal expiration and at the midway between the inferior costal margin and the superior border of the iliac crest.
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 6 Oct 2023.
- 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.
Rafael Tabarés-Seisdedos principal investigator
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Questions about this trial
What is this clinical trial studying?
A study testing Guided physical activity and Standard physical activity in people with Severe Mental Disorder and Obesity, run by Fundación para la Investigación del Hospital Clínico de Valencia.
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 9 inclusion and 13 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Verbal learning and memory (time frame: 4 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.