Post-cardiac SurgeryNCT06460740
Comb Effect of 4-7-8 Breathing Technique and Stationary Cycle on PP, QOL and Dyspnea in Post CABG Patients.
A study testing 4-7-8 breathing technique and Stationary Cycling in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- 4-7-8 breathing technique and Stationary Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 1 Jul 2024
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent a successful CABG (no complications during surgery
- and/or in the following weeks)
- Female and male whose age between 40 to 70 years of age
- Phase II cardiac rehab patients
- Patients who were extubated and hemodynamically stable
- Patients with stable chronic heart failure.
Show all 9Show fewer
- Patients had no arrhythmias
- Patients who had ability to read and write
- Patients who voluntarily participated in the study.
Who cannot join
- Ventricular Septal defect repair.
- Patients have limitation of motion that prevents them from performing physical activities such as walking for 6 minute.
- Patients who had undergone previous cardiac surgery.
- Severe renal dysfunction requiring dialysis.
- Altered level of consciousness.
- A history of musculoskeletal problems
Show all 10Show fewer
- Having an orthopedic problem that prevents the use of lower and upper extremity bikes.
- Cancer patients receiving radiotherapy and chemotherapy.
- Clinical diagnosis of uncontrolled Diabetes Mellitus and Hypertension.
- Physical Discomfort at any stage of the study and/or any reaction to the tests (nausea, dizziness, discomfort, feeling faint, tachycardia, excessive sweating), and if they failed to attend the scheduled sessions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Medicare Cardiac and General Hospital
Karachi, Sindh, 74800
Qurat ul-Ain, MSCPPT, +92-031-21707719, qurat.ain@riphah.edu.pk
Samrah Mahmood, MSCPPT
About this study
Official title: Combined Effects of 4-7-8 Breathing Technique and Stationary Cycle on Physical Performance, Quality of Life and Dyspnea in Post CABG Patients
To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients.
Read the detailed description
Patients who meet the inclusion criteria and will be excluded from the exclusion criteria will be recruited by convenient sampling technique and will be allocated to simple randomization process. By taking a sample of 58 patients through non-probability convenience sampling and randomly assigning them into two groups, Group A and Group B for 18 exercise sessions per month (four to five times in a week), out of which group A will receive 4-7-8 breathing technique and stationary cycle (n=29). Group B will alone receive Stationary cycle (n=29). The study will be Single-blind where patients will be only blind. Pre and post treatment training outcomes of physical performance will be measured through 6-minute walk test, quality of life will be measured through Short-item 36 (SF-36) questionnaire 2.0 version and dyspnea will be measured through modified Borg scale. The data will be analyzed through SPSS version 26. Generalized active range of motion will be given to both groups.
- Conditions
- Post-cardiac Surgery
- Being tested
- 4-7-8 breathing technique, Stationary Cycling
- Keywords
- 4-7-8 breathing technique, stationary cycling, Post CABG, physical performance, quality of life, Dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 breathing techniqueOther
Also called Generalized Active ROM
Treatment will be given 18 exercise sessions per month (four to five times per week). The patient at first will be directed to sit or lie down, in which manner they feel sense of comfort. Then they are asked to exhale completely through mouth emptying their lungs. Then closing their lips and inhaling silently through nose while counting on the count of 4 seconds, holding their breath for a count of 7 seconds and exhale slowly through semi-closed lips making a Whoosh sound for a count of 8 seconds. Inhale, hold breath, and exhale ratio of 4:7:8. In aerobic protocol, F (frequency) subjects will receive training up to 18 exercise sessions per month (four to five times per week). I (intensity) subjects will receive training up to intensity of 70 to 75 %, T \& T (Time and Type) subjects will receive training up to 20 minutes of bicycling.
Stationary CyclingOther
Also called Generalized Active ROM
In aerobic protocol, F (frequency) subjects will receive training up to 18 exercise sessions per month (four to five times per week). I (intensity) subjects will receive training up to intensity of 70 to 75 %, T \& T (Time and Type) subjects will receive training up to 20 minutes of bicycling
| Study group | Role | What they receive |
|---|---|---|
| 4-7-8 breathing technique | Experimental | 4-7-8 breathing technique and stationary cycling Receives: Other: 4-7-8 breathing technique |
| Stationary cycling | Active comparator | Stationary Cycling Receives: Other: Stationary Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Performance 6MWT
Changes from baseline The 6-minute walk test (6MWT) was developed by American Thoracic society and was officially introduced in 2002, coming along with a comprehensive guideline. The 6MWT is an easy, safe, reliable and simple cardiopulmonary sub maximal functional testing modality, used to assess functional capacity and to evaluate the cardiac and pulmonary rehabilitation treatment or intervention. (16) The individuals were requested to walk as far-off as they are able to on a smooth area for about 6 minutes. Individuals were permitted to take a rest or stop from walking if it was required then continue again as quick as they can. The distance covered by individuals for this test was measured in meters.
Measured: 4th week
Secondary outcomes (2)
SF-36 Quality of Life Questionnaire version 2.0
Changes from baseline the 36 item Short-Form Survey (SF-36) is an outcome measure standardized structured questionnaire that is internationally and widely approved to evaluate the quality of life (QOL) of post CABG patients. The questionnaire was developed and used for collecting a data. The content validity was obtained from 7 experts. The questionnaire was found to be valid in assessing QOL. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: 4th week
Modified Borg Dyspnea Scale
Changes from baseline Borg rate of perceived exertion (RPE) or Rate of perceived dyspnea (RPD) is an outcome measuring scale was developed by Swedish researcher Gunnar Borg in the 1998, allowing the individuals to rate their level of exertion during exercise subjectively American College of Sports Medicine (ACSM), 2010. It is proposed for all patients who underwent and going through Rehabilitation and endurance training as well as used in research. It scores from 0 to 10, using numeric values to rate how much effort an activity takes or to rate the difficulty of breathing. The zero point in a scale, indicates breathing is causing no difficulty at all or no exertion at all progressing through to ten point where breathing difficult is at maximum point.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat ul-Ain, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460740
- Sponsor's protocol ID
- REC/47039 Samrah Mahmood
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wahdan Abd El-Aziz W, Attia Kandee N, Elsayed Mansour H. The Effect of Early SixMinute Walking Test Post-Coronary Artery Bypass Graft on Walking Tolerance and Physiological Parameters. Egyptian Journal of Health Care. 2020;11(3):784-94.
Ambina K, Shalimol U, Anjana A. Quality of Life among Post CABG Patients. Prof(Dr) RK Sharma. 2020;20(4):41535.
Abdelaziz Mohammed F, Shoeib Ali F. Effect of Early Ambulation Program on Selected Outcomes among Patients Undergoing Cardiac Surgery. Egyptian Journal of Health Care. 2022;13(4):888-904.
Schulte B, Nieborak L, Leclercq F, Villafane JH, Sanchez Romero EA, Corbellini C. The Comparison of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training after Coronary Artery Bypass Graft: A Systematic Review of Recent Studies. J Cardiovasc Dev Dis. 2022 Sep 28;9(10):328. doi: 10.3390/jcdd9100328.
PubMed 36286280Kansara P, Patel S. Effect of Post Operative Physiotherapy in Patients with CABG to Improve Cardiovascular Endurance-A Randomised Controlled Trial.
Yükselmiş Ö. The Effect of Cycling and Arm Ergometer Exercises on Physical and Psychosocial Functions: Application in Patients Undergoing Coronary Artery Bypass Surgery. Open Journal of Therapy and Rehabilitation. 2022;10(2):39-53
Munir U, Umar Riaz NF, Sahar W, Tariq K. Effects of Preoperative Aerobic Training for Improving Postoperative Functional Mobility in Coronary Artery Bypass Graft Patients. 2023.
Naqvi M, Khan MS, Perwaiz S, Ibrahim Q, Khan MW, Khan TY. Comparative analysis on the efficacy of aerobic capacity in cardiac rehabilitation obese and non-obese phase ii patient. International Journal of Physiotherapy. 2019:64-9.
Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.
PubMed 35822447Krasavina T, Zaborova V, Lazareva I, Yurku K, Putilo V, Gameeva V, et al. Rehabilitation of patients with coronary heart disease after coronary artery bypass grafting at the stationary stage. Journal of IMAB-Annual Proceeding Scientific Papers. 2023;29(2):4980-3.
Hamed LA, Elsayed SM. Effect of Deep Breathing Exercises on Pain after Cardiac Catheterization: A Randomized Controlled Trial.
Gambassi BB, Almeida FJF, Almeida AEAF, Ribeiro DAF, Gomes RSA, Chaves LFC, Sousa TMDS, Nina VJDS. Acute Response to Aerobic Exercise on Autonomic Cardiac Control of Patients in Phase III of a Cardiovascular Rehabilitation Program Following Coronary Artery Bypass Grafting. Braz J Cardiovasc Surg. 2019 Jun 1;34(3):305-310. doi: 10.21470/1678-9741-2019-0030.
PubMed 31310469Sheraz S, Ayub H, Ferraro FV, Razzaq A, Malik AN. Clinically Meaningful Change in 6 Minute Walking Test and the Incremental Shuttle Walking Test following Coronary Artery Bypass Graft Surgery. Int J Environ Res Public Health. 2022 Nov 1;19(21):14270. doi: 10.3390/ijerph192114270.
PubMed 36361150Moreira JMA, Grilo EN. Quality of life after coronary artery bypass graft surgery - results of cardiac rehabilitation programme. J Exerc Rehabil. 2019 Oct 28;15(5):715-722. doi: 10.12965/jer.1938444.222. eCollection 2019 Oct.
PubMed 31723562Ghorbani A, Hajizadeh F, Sheykhi MR, Mohammad Poor Asl A. The Effects of Deep-Breathing Exercises on Postoperative Sleep Duration and Quality in Patients Undergoing Coronary Artery Bypass Graft (CABG): a Randomized Clinical Trial. J Caring Sci. 2018 Dec 1;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.
PubMed 31915624
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of 4-7-8 Breathing Technique and Stationary Cycle on Physical Performance, Quality of Life and Dyspnea in Post CABG Patients
- ClinicalTrials.gov ID
- NCT06460740
- Acronym / sponsor ID
- REC/47039 Samrah Mahmood
- Conditions
- Post-cardiac Surgery
- Keywords
- 4-7-8 breathing technique, stationary cycling, Post CABG, physical performance, quality of life, Dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients.
Detailed description
Patients who meet the inclusion criteria and will be excluded from the exclusion criteria will be recruited by convenient sampling technique and will be allocated to simple randomization process. By taking a sample of 58 patients through non-probability convenience sampling and randomly assigning them into two groups, Group A and Group B for 18 exercise sessions per month (four to five times in a week), out of which group A will receive 4-7-8 breathing technique and stationary cycle (n=29). Group B will alone receive Stationary cycle (n=29). The study will be Single-blind where patients will be only blind. Pre and post treatment training outcomes of physical performance will be measured through 6-minute walk test, quality of life will be measured through Short-item 36 (SF-36) questionnaire 2.0 version and dyspnea will be measured through modified Borg scale. The data will be analyzed through SPSS version 26. Generalized active range of motion will be given to both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-7-8 breathing technique | Experimental | Other: 4-7-8 breathing technique4-7-8 breathing technique and stationary cycling |
| Stationary cycling | Active comparator | Other: Stationary CyclingStationary Cycling |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who underwent a successful CABG (no complications during surgery
- and/or in the following weeks)
- Female and male whose age between 40 to 70 years of age
- Phase II cardiac rehab patients
- Patients who were extubated and hemodynamically stable
Key exclusion criteria (10 listed)
- Ventricular Septal defect repair.
- Patients have limitation of motion that prevents them from performing physical activities such as walking for 6 minute.
- Patients who had undergone previous cardiac surgery.
- Severe renal dysfunction requiring dialysis.
- Altered level of consciousness.
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 |
|---|---|---|
| 4-7-8 breathing techniqueAlso: Generalized Active ROMTreatment will be given 18 exercise sessions per month (four to five times per week). The patient at first will be directed to sit or lie down, in which manner they feel sense of comfort. Then they are asked to exhale completely through mouth emptying their lungs. Then closing their lips and inhaling silently through nose while counting on the count of 4 seconds, holding their breath for a count of 7 seconds and exhale slowly through semi-closed lips making a Whoosh sound for a count of 8 seconds. Inhale, hold breath, and exhale ratio of 4:7:8. In aerobic protocol, F (frequency) subjects will receive training up to 18 exercise sessions per month (four to five times per week). I (intensity) subjects will receive training up to intensity of 70 to 75 %, T \& T (Time and Type) subjects will receive training up to 20 minutes of bicycling. | Other | 4-7-8 breathing technique |
| Stationary CyclingAlso: Generalized Active ROMIn aerobic protocol, F (frequency) subjects will receive training up to 18 exercise sessions per month (four to five times per week). I (intensity) subjects will receive training up to intensity of 70 to 75 %, T \& T (Time and Type) subjects will receive training up to 20 minutes of bicycling | Other | Stationary cycling |
Primary outcome
Physical Performance 6MWT
Time frame: 4th week
Changes from baseline The 6-minute walk test (6MWT) was developed by American Thoracic society and was officially introduced in 2002, coming along with a comprehensive guideline. The 6MWT is an easy, safe, reliable and simple cardiopulmonary sub maximal functional testing modality, used to assess functional capacity and to evaluate the cardiac and pulmonary rehabilitation treatment or intervention. (16) The individuals were requested to walk as far-off as they are able to on a smooth area for about 6 minutes. Individuals were permitted to take a rest or stop from walking if it was required then continue again as quick as they can. The distance covered by individuals for this test was measured in meters.
2 secondary outcomes
SF-36 Quality of Life Questionnaire version 2.0
Time frame: 4th week
Modified Borg Dyspnea Scale
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- BackgroundWahdan Abd El-Aziz W, Attia Kandee N, Elsayed Mansour H. The Effect of Early SixMinute Walking Test Post-Coronary Artery Bypass Graft on Walking Tolerance and Physiological Parameters. Egyptian Journal of Health Care. 2020;11(3):784-94.
- BackgroundAmbina K, Shalimol U, Anjana A. Quality of Life among Post CABG Patients. Prof(Dr) RK Sharma. 2020;20(4):41535.
- BackgroundAbdelaziz Mohammed F, Shoeib Ali F. Effect of Early Ambulation Program on Selected Outcomes among Patients Undergoing Cardiac Surgery. Egyptian Journal of Health Care. 2022;13(4):888-904.
- Background: PubMed 36286280Schulte B, Nieborak L, Leclercq F, Villafane JH, Sanchez Romero EA, Corbellini C. The Comparison of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training after Coronary Artery Bypass Graft: A Systematic Review of Recent Studies. J Cardiovasc Dev Dis. 2022 Sep 28;9(10):328. doi: 10.3390/jcdd9100328.
- BackgroundKansara P, Patel S. Effect of Post Operative Physiotherapy in Patients with CABG to Improve Cardiovascular Endurance-A Randomised Controlled Trial.
- BackgroundYükselmiş Ö. The Effect of Cycling and Arm Ergometer Exercises on Physical and Psychosocial Functions: Application in Patients Undergoing Coronary Artery Bypass Surgery. Open Journal of Therapy and Rehabilitation. 2022;10(2):39-53
- BackgroundMunir U, Umar Riaz NF, Sahar W, Tariq K. Effects of Preoperative Aerobic Training for Improving Postoperative Functional Mobility in Coronary Artery Bypass Graft Patients. 2023.
- BackgroundNaqvi M, Khan MS, Perwaiz S, Ibrahim Q, Khan MW, Khan TY. Comparative analysis on the efficacy of aerobic capacity in cardiac rehabilitation obese and non-obese phase ii patient. International Journal of Physiotherapy. 2019:64-9.
- Background: PubMed 35822447Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.
- BackgroundKrasavina T, Zaborova V, Lazareva I, Yurku K, Putilo V, Gameeva V, et al. Rehabilitation of patients with coronary heart disease after coronary artery bypass grafting at the stationary stage. Journal of IMAB-Annual Proceeding Scientific Papers. 2023;29(2):4980-3.
- BackgroundHamed LA, Elsayed SM. Effect of Deep Breathing Exercises on Pain after Cardiac Catheterization: A Randomized Controlled Trial.
- Background: PubMed 31310469Gambassi BB, Almeida FJF, Almeida AEAF, Ribeiro DAF, Gomes RSA, Chaves LFC, Sousa TMDS, Nina VJDS. Acute Response to Aerobic Exercise on Autonomic Cardiac Control of Patients in Phase III of a Cardiovascular Rehabilitation Program Following Coronary Artery Bypass Grafting. Braz J Cardiovasc Surg. 2019 Jun 1;34(3):305-310. doi: 10.21470/1678-9741-2019-0030.
- Individual participant dataSharing planned: No
Related trials for Post-cardiac Surgery
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
RecruitingObservational study
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction
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.
Qurat ul-Ain, MSCPPT 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 4-7-8 breathing technique and Stationary Cycling in people with Post-cardiac Surgery, 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 9 inclusion and 10 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 26 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Performance 6MWT (time frame: 4th week). 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 NCT06460740, which also lists 16 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 26 Jun 2024.