HypertensionNCT05409456
Comparative Effects of Mild and Moderate Aerobic Exercises on BP, VO2 and HR in Hypertensive Patients
A study testing mild aerobic exercise and moderate aerobic exercise in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Hypertension
- What is being tested?
- mild aerobic exercise and moderate aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 11 May 2022to 15 Aug 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 40 to 55
- Gender: male and female
- Chronic hypertensive stable patients (130 - 159mmHg / 85 - 99mmHg) (3)
- History of hypertension from last 1 year(14)
- Taking anti-hypertensive medicines (ACE inhibitors, calcium channel blockers, thiazide diuretics, ACE receptor inhibitors, beta blockers) more than 6 hours ago
Who cannot join
- History of ischemia
- History of stroke
- Chronic obstructive and restrictive disease
- Hypo and hypernatremia
- Joint disease patients
- Lower limb fracture
- Chronic atrial fibrillation
- Change in drug therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Mild and Moderate Aerobic Exercises on Blood Pressure, Oxygen Saturation and Heart Rate in Hypertensive Patients
World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the "silent killer".
More than 1 in 5 adults worldwide had raised blood pressure. There has been studies on strength exercise, severe aerobic exercise and other types of exercises and on their effects on blood pressure, heart rate and oxygen saturation in other patient populations and on healthy individuals as well, but in the patients with hypertension no comparison has been made between mild and moderate aerobic exercise (tread mill) yet, stating which one is effective. Secondly, already present studies have shown long term effects mostly, not the comparative effects of mild and moderate exercises on blood pressure heart rate and oxygen saturation of patients with hypertension. These techniques are inexpensive, easy to perform and contain no known harmful effect. Hence, current study will undertake this task of finding out what are the comparative effects of mild and moderate aerobic on the BP, heart rate and oxygen saturation and secondly which technique is more effective. Study design will Randomized clinical trial with non-probability convenient sampling.
Read more
It will be single blinded study with blinding of assessor. Sample size was calculated from Epitools website and will be 28. There will be two groups which will be randomly assigned 14 people using lottery method. Data will be collected from community dwelling areas of Lahore Patients with hypertension with Systolic Blood Pressure 130 - 159 mmHg and Diastolic Blood Pressure 85 - 99 mmHg (pre hypertensive and stage 1), 30 to 50 years of age, patients who have taken any antihypertensive medicine in more than 6 hours and both males and females will be recruited. Tools will be aneroid sphygmomanometer for measuring blood pressure and pulse oximeter for measuring oxygen saturation and heart rate and Post interventional BP, heart rate readings and oxygen saturation will be taken for both groups on the same day.
Post intervention blood pressure, Heart rate and oxygen saturation will be taken after 5 minutes.
Read the detailed description
World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the "silent killer".
More than 1 in 5 adults worldwide had raised blood pressure. There has been studies on strength exercise, severe aerobic exercise and other types of exercises and on their effects on blood pressure, heart rate and oxygen saturation in other patient populations and on healthy individuals as well, but in the patients with hypertension no comparison has been made between mild and moderate aerobic exercise (tread mill) yet, stating which one is effective. Secondly, already present studies have shown long term effects mostly, not the comparative effects of mild and moderate exercises on blood pressure heart rate and oxygen saturation of patients with hypertension. These techniques are inexpensive, easy to perform and contain no known harmful effect. Hence, current study will undertake this task of finding out what are the comparative effects of mild and moderate aerobic on the BP, heart rate and oxygen saturation and secondly which technique is more effective. Study design will Randomized clinical trial with non-probability convenient sampling.
It will be single blinded study with blinding of assessor. Sample size was calculated from Epitools website and will be 28. There will be two groups which will be randomly assigned 14 people using lottery method. Data will be collected from community dwelling areas of Lahore Patients with hypertension with Systolic Blood Pressure 130 - 159 mmHg and Diastolic Blood Pressure 85 - 99 mmHg (pre hypertensive and stage 1), 30 to 50 years of age, patients who have taken any antihypertensive medicine in more than 6 hours and both males and females will be recruited. Tools will be aneroid sphygmomanometer for measuring blood pressure and pulse oximeter for measuring oxygen saturation and heart rate and Post interventional BP, heart rate readings and oxygen saturation will be taken for both groups on the same day.
Post intervention blood pressure, Heart rate and oxygen saturation will be taken after 5 minutes. Key words: HTN hypertension, HR heart rate, BP blood pressure, vo2max maximum oxygen uptake in unit of time.
- Conditions
- Hypertension
- Being tested
- mild aerobic exercise, moderate aerobic exercise
- Keywords
- HTN hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild aerobic exerciseOther
Also called aerobic
mild aerobic exercise given to group A on treadmill
moderate aerobic exerciseOther
Also called aerobic
moderate aerobic exercise given to group B on treadmill
| Study group | Role | What they receive |
|---|---|---|
| mild aerobic exercise | Experimental | group A was given mild aerobic exercise on treadmill with warm up exercise Receives: Other: mild aerobic exercise |
| moderate aerobic exercise | Experimental | group B was moderate aerobic on treadmill with warm up exercise Receives: Other: moderate aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
measuring blood pressure by Manual Sphygmomanometer BP apparatus: is the instrument which is used to measure blood pressure if systolic blood pressure is greater than 120 mmHg and diastolic is higher than 90 mmHg is considered hypertensive. Cuff is apply on dominant hand inflate the cuff if sound is appear that is systolic if sound is not hear that is diastolic blood pressure in mmHg.
Measured: 6 weeks
Secondary outcomes (2)
oxygen saturation
measuring oxygen saturation by Pulse oximetry: is the instrument which measure the oxygen saturation and heart rate. Blood Oxygen Saturation (SpO2): The measurement that indicates what percentage of blood is saturated. Normal pulse oximeter readings usually range from 95 to 100 percent. While anything less than 95% indicates underlying medical conditions that need to be evaluated immediately. Pulse Rate / heart rate: Pulse rate is nothing but the heart rate that indicates the number of times a heart beats per minute I.e. 72b/m.
Measured: 6 weeks
heart rate
measuring heart rate by Pulse oximetry: is the instrument which measure the oxygen saturation and heart rate. Blood Oxygen Saturation (SpO2): The measurement that indicates what percentage of blood is saturated. Normal pulse oximeter readings usually range from 95 to 100 percent. While anything less than 95% indicates underlying medical conditions that need to be evaluated immediately. Pulse Rate / heart rate: Pulse rate is nothing but the heart rate that indicates the number of times a heart beats per minute I.e. 72b/m.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start11 May 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups group A is assign mild aerobic group b is assign moderate aerobic
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tasneem Shehzadi, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409456
- Sponsor's protocol ID
- REC/22/0330 Marryam
- Status last verified
- Dec 2022
- First submitted
- 26 May 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clausen JP, Klausen K, Rasmussen B, Trap-Jensen J. Central and peripheral circulatory changes after training of the arms or legs. Am J Physiol. 1973 Sep;225(3):675-82. doi: 10.1152/ajplegacy.1973.225.3.675. No abstract available.
PubMed 4726503Cao L, Li X, Yan P, Wang X, Li M, Li R, Shi X, Liu X, Yang K. The effectiveness of aerobic exercise for hypertensive population: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2019 Jul;21(7):868-876. doi: 10.1111/jch.13583. Epub 2019 Jun 6.
PubMed 31169988Nascimento LS, Santos AC, Lucena J, Silva L, Almeida A, Brasileiro-Santos MS. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):250. doi: 10.1186/s13063-017-1985-5.
PubMed 28578691Wen H, Wang L. Reducing effect of aerobic exercise on blood pressure of essential hypertensive patients: A meta-analysis. Medicine (Baltimore). 2017 Mar;96(11):e6150. doi: 10.1097/MD.0000000000006150.
PubMed 28296729Dimeo F, Pagonas N, Seibert F, Arndt R, Zidek W, Westhoff TH. Aerobic exercise reduces blood pressure in resistant hypertension. Hypertension. 2012 Sep;60(3):653-8. doi: 10.1161/HYPERTENSIONAHA.112.197780. Epub 2012 Jul 16.
PubMed 22802220Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.
PubMed 23478192Roque FR, Briones AM, Garcia-Redondo AB, Galan M, Martinez-Revelles S, Avendano MS, Cachofeiro V, Fernandes T, Vassallo DV, Oliveira EM, Salaices M. Aerobic exercise reduces oxidative stress and improves vascular changes of small mesenteric and coronary arteries in hypertension. Br J Pharmacol. 2013 Feb;168(3):686-703. doi: 10.1111/j.1476-5381.2012.02224.x.
PubMed 22994554Westhoff TH, Schmidt S, Gross V, Joppke M, Zidek W, van der Giet M, Dimeo F. The cardiovascular effects of upper-limb aerobic exercise in hypertensive patients. J Hypertens. 2008 Jul;26(7):1336-42. doi: 10.1097/HJH.0b013e3282ffac13.
PubMed 18551008Ciolac EG, Guimaraes GV, D'Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute aerobic exercise reduces 24-h ambulatory blood pressure levels in long-term-treated hypertensive patients. Clinics (Sao Paulo). 2008 Dec;63(6):753-8. doi: 10.1590/s1807-59322008000600008.
PubMed 19060996
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Mild and Moderate Aerobic Exercises on Blood Pressure, Oxygen Saturation and Heart Rate in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05409456
- Acronym / sponsor ID
- REC/22/0330 Marryam
- Conditions
- Hypertension
- Keywords
- HTN hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 8 Jun 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.
World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the "silent killer".
More than 1 in 5 adults worldwide had raised blood pressure. There has been studies on strength exercise, severe aerobic exercise and other types of exercises and on their effects on blood pressure, heart rate and oxygen saturation in other patient populations and on healthy individuals as well, but in the patients with hypertension no comparison has been made between mild and moderate aerobic exercise (tread mill) yet, stating which one is effective. Secondly, already present studies have shown long term effects mostly, not the comparative effects of mild and moderate exercises on blood pressure heart rate and oxygen saturation of patients with hypertension. These techniques are inexpensive, easy to perform and contain no known harmful effect. Hence, current study will undertake this task of finding out what are the comparative effects of mild and moderate aerobic on the BP, heart rate and oxygen saturation and secondly which technique is more effective. Study design will Randomized clinical trial with non-probability convenient sampling.
It will be single blinded study with blinding of assessor. Sample size was calculated from Epitools website and will be 28. There will be two groups which will be randomly assigned 14 people using lottery method. Data will be collected from community dwelling areas of Lahore Patients with hypertension with Systolic Blood Pressure 130 - 159 mmHg and Diastolic Blood Pressure 85 - 99 mmHg (pre hypertensive and stage 1), 30 to 50 years of age, patients who have taken any antihypertensive medicine in more than 6 hours and both males and females will be recruited. Tools will be aneroid sphygmomanometer for measuring blood pressure and pulse oximeter for measuring oxygen saturation and heart rate and Post interventional BP, heart rate readings and oxygen saturation will be taken for both groups on the same day.
Post intervention blood pressure, Heart rate and oxygen saturation will be taken after 5 minutes.
Detailed description
World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the "silent killer".
More than 1 in 5 adults worldwide had raised blood pressure. There has been studies on strength exercise, severe aerobic exercise and other types of exercises and on their effects on blood pressure, heart rate and oxygen saturation in other patient populations and on healthy individuals as well, but in the patients with hypertension no comparison has been made between mild and moderate aerobic exercise (tread mill) yet, stating which one is effective. Secondly, already present studies have shown long term effects mostly, not the comparative effects of mild and moderate exercises on blood pressure heart rate and oxygen saturation of patients with hypertension. These techniques are inexpensive, easy to perform and contain no known harmful effect. Hence, current study will undertake this task of finding out what are the comparative effects of mild and moderate aerobic on the BP, heart rate and oxygen saturation and secondly which technique is more effective. Study design will Randomized clinical trial with non-probability convenient sampling.
It will be single blinded study with blinding of assessor. Sample size was calculated from Epitools website and will be 28. There will be two groups which will be randomly assigned 14 people using lottery method. Data will be collected from community dwelling areas of Lahore Patients with hypertension with Systolic Blood Pressure 130 - 159 mmHg and Diastolic Blood Pressure 85 - 99 mmHg (pre hypertensive and stage 1), 30 to 50 years of age, patients who have taken any antihypertensive medicine in more than 6 hours and both males and females will be recruited. Tools will be aneroid sphygmomanometer for measuring blood pressure and pulse oximeter for measuring oxygen saturation and heart rate and Post interventional BP, heart rate readings and oxygen saturation will be taken for both groups on the same day.
Post intervention blood pressure, Heart rate and oxygen saturation will be taken after 5 minutes. Key words: HTN hypertension, HR heart rate, BP blood pressure, vo2max maximum oxygen uptake in unit of time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups group A is assign mild aerobic group b is assign moderate aerobic
| Arm | Type | Receives |
|---|---|---|
| mild aerobic exercise | Experimental | Other: mild aerobic exercisegroup A was given mild aerobic exercise on treadmill with warm up exercise |
| moderate aerobic exercise | Experimental | Other: moderate aerobic exercisegroup B was moderate aerobic on treadmill with warm up exercise |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 40 to 55
- Gender: male and female
- Chronic hypertensive stable patients (130 - 159mmHg / 85 - 99mmHg) (3)
- History of hypertension from last 1 year(14)
- Taking anti-hypertensive medicines (ACE inhibitors, calcium channel blockers, thiazide diuretics, ACE receptor inhibitors, beta blockers) more than 6 hours ago
Key exclusion criteria (8 listed)
- History of ischemia
- History of stroke
- Chronic obstructive and restrictive disease
- Hypo and hypernatremia
- Joint disease patients
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 |
|---|---|---|
| mild aerobic exerciseAlso: aerobicmild aerobic exercise given to group A on treadmill | Other | mild aerobic exercise |
| moderate aerobic exerciseAlso: aerobicmoderate aerobic exercise given to group B on treadmill | Other | moderate aerobic exercise |
Primary outcome
blood pressure
Time frame: 6 weeks
measuring blood pressure by Manual Sphygmomanometer BP apparatus: is the instrument which is used to measure blood pressure if systolic blood pressure is greater than 120 mmHg and diastolic is higher than 90 mmHg is considered hypertensive. Cuff is apply on dominant hand inflate the cuff if sound is appear that is systolic if sound is not hear that is diastolic blood pressure in mmHg.
2 secondary outcomes
oxygen saturation
Time frame: 6 weeks
heart rate
Time frame: 6 weeks
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 9 Dec 2022.
- Background: PubMed 4726503Clausen JP, Klausen K, Rasmussen B, Trap-Jensen J. Central and peripheral circulatory changes after training of the arms or legs. Am J Physiol. 1973 Sep;225(3):675-82. doi: 10.1152/ajplegacy.1973.225.3.675. No abstract available.
- Background: PubMed 31169988Cao L, Li X, Yan P, Wang X, Li M, Li R, Shi X, Liu X, Yang K. The effectiveness of aerobic exercise for hypertensive population: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2019 Jul;21(7):868-876. doi: 10.1111/jch.13583. Epub 2019 Jun 6.
- Background: PubMed 28578691Nascimento LS, Santos AC, Lucena J, Silva L, Almeida A, Brasileiro-Santos MS. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):250. doi: 10.1186/s13063-017-1985-5.
- Background: PubMed 28296729Wen H, Wang L. Reducing effect of aerobic exercise on blood pressure of essential hypertensive patients: A meta-analysis. Medicine (Baltimore). 2017 Mar;96(11):e6150. doi: 10.1097/MD.0000000000006150.
- Background: PubMed 22802220Dimeo F, Pagonas N, Seibert F, Arndt R, Zidek W, Westhoff TH. Aerobic exercise reduces blood pressure in resistant hypertension. Hypertension. 2012 Sep;60(3):653-8. doi: 10.1161/HYPERTENSIONAHA.112.197780. Epub 2012 Jul 16.
- Background: PubMed 23478192Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.
- Background: PubMed 22994554Roque FR, Briones AM, Garcia-Redondo AB, Galan M, Martinez-Revelles S, Avendano MS, Cachofeiro V, Fernandes T, Vassallo DV, Oliveira EM, Salaices M. Aerobic exercise reduces oxidative stress and improves vascular changes of small mesenteric and coronary arteries in hypertension. Br J Pharmacol. 2013 Feb;168(3):686-703. doi: 10.1111/j.1476-5381.2012.02224.x.
- Background: PubMed 18551008Westhoff TH, Schmidt S, Gross V, Joppke M, Zidek W, van der Giet M, Dimeo F. The cardiovascular effects of upper-limb aerobic exercise in hypertensive patients. J Hypertens. 2008 Jul;26(7):1336-42. doi: 10.1097/HJH.0b013e3282ffac13.
- Background: PubMed 19060996Ciolac EG, Guimaraes GV, D'Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute aerobic exercise reduces 24-h ambulatory blood pressure levels in long-term-treated hypertensive patients. Clinics (Sao Paulo). 2008 Dec;63(6):753-8. doi: 10.1590/s1807-59322008000600008.
- 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.
Tasneem Shehzadi, Mphil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mild aerobic exercise and moderate aerobic exercise in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 8 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 9 Dec 2022. 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 Pakistan. 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 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?
blood pressure (time frame: 6 weeks). 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 NCT05409456, which also lists 9 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 9 Dec 2022.