CADNCT07128849
Effect of Phase I Cardiac Rehab With or Without Upper Limb Cycle Ergometer
A study testing upper limb exercise with arm ergometer and upper limb exercise with out arm ergometer in people with CAD, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to investigate the effects of an upper limb cycle ergometer in phase I CABG patients. This will likely enhance various outcomes such as quality of life, dyspnea, functional outcome measure, cardiovascular parameters, and upper limb mobility. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- CAD
- What is being tested?
- upper limb exercise with arm ergometer and upper limb exercise with out arm ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned CABG patients
- 40-65 years
- Both male and female
- Hemodynamic stable patients
- Post extubation
Who cannot join
- Patients suffering from pulmonary diseases and thyroid disorders
- Mechanical ventilation more than 24 hr
- Mean arterial pressure i.e, < 60 mmHg or > 140 mmHg and heart rate not more than 120bpm
- Having an orthopedic condition that makes the use of upper and lower extremity impossible.
- Who have neurological impairment influencing breathing rate and heart rate.
- Who required the implantation of an intra-aortic balloon during surgery
- Who experienced postoperative complications such as pulmonary embolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital
Lahore, Punjab Province, 54000
Iram Nawaz, mphill, 03324645227, iram_029@yahoo.com
misbah qayum, MSCPPT
About this study
Official title: Effects of Phase I Cardiac Rehabilitation With and Without Upper Limb Cycle Ergometer in Immediate Post-Operative Period of CABG
The aim of the study is to investigate the effects of an upper limb cycle ergometer in phase I CABG patients. This will likely enhance various outcomes such as quality of life, dyspnea, functional outcome measure, cardiovascular parameters, and upper limb mobility. If utilized, the arm ergometer may contribute to improve upper limb strength and endurance. This could result in improving upper limb range of motion and reducing the risk of adhesive capsulitis. This study will positively impact society by reducing morbidity and mortality rates, healthcare costs and ultimately improves patient care.
Read the detailed description
The most often done major surgical surgery is coronary artery bypass grafting (CABG), a significant surgical procedure by using harvested venous or arterial conduit to bypass atheromatous obstructions in a patient's coronary arteries. Following heart surgery, patients face many complications that increases the duration of stay in the intensive care unit (ICU) and hospital, as well as the death rates following surgery. Following coronary artery bypass grafting (CABG), compliance with the cardiac rehabilitation (CR) regimen is essential. Cardiac rehabilitation in phase I include mobilization, respiratory and physical exercises, education on heart disease risk factors, and stress and anxiety management. An apparatus designed to help physiotherapists to increase muscle training is the upper limb cycle ergometer. It is possible to execute cyclical rotations with this equipment and utilize it for resistive, active, and passive patient exercise. Patients who have had coronary artery bypass surgery report improved physical and psychosocial functioning after engaging in arm ergometer workouts. The aim of this study is to investigate the effects of phase I cardiac rehabilitation on quality of life, dyspnea, functional outcome measure and cardiovascular parameters with and without upper limb cycle ergometer in immediate post-operative period of CABG.
A randomized clinical trial will be conducted at Combined Military Hospital Lahore. Non-probability convenient sampling technique will be applied on the patients according to the inclusion criteria. Patient will be randomly allocated through lottery method into group A and group B to collect data. Group A will receive upper limb exercise on arm ergometer lasting 5 min at 30 rpm (rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises, active upper and lower exercises (3 sets of 10 repetitions daily for 7 days); ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30 min), that will be progressed as patient condition till 7th day. Group B will receive same standard treatment as above, but without arm ergometer. The study will be completed within the time duration of ten months. Treatment evaluation of patients will be done after one week through 36-Item Short Form Survey (SF-36), Modified Medical Research Council Dyspnea scale, and Functional Independence Measure scale. Data will be analyzed using SPSS software version 27. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- CAD
- Being tested
- upper limb exercise with arm ergometer, upper limb exercise with out arm ergometer
- Keywords
- phase I cardiac rehabilitation, upper limb cycle ergometer, post op period CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper limb exercise with arm ergometerOther
upper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day
upper limb exercise with out arm ergometerOther
standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day
| Study group | Role | What they receive |
|---|---|---|
| upper limb exercise with arm ergometer | Experimental | Group A will receive upper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day Receives: Other: upper limb exercise with arm ergometer |
| upper limb exercise with out arm ergometer | Active comparator | Group B will receive standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day Receives: Other: upper limb exercise with out arm ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence Measure (FIM)
There are eighteen items in the FIM, and each item has a maximum score of seven points, a minimum score of one point, and and a maximum score of 126 points overall. The FIM has eighteen items, of which thirteen are used to test motor ADL (six self-care items, two sphincter control tasks, three transfer items, and two motor items), and the other five are used to assess cognitive ADL (two items for communication and three items for social cognition).
Measured: 7 days
36- Item Short Form Survey Instrument
The SF-36 brief survey, which includes 36 items across eight categories of QOL, is a standardised tool for assessing generic health concepts. It includes ten items related to physical functioning, four items related to physical problems, five items related to general mental health, three items related to emotional problems, and two items related to relationships with family and friends. General health, which includes six items regarding the patient's personal opinion of health; physical pain, which includes 2 items about the patient's body pain intensity; and energy or vitality, which includes four things about vitality, exhaustion, and tiredness. There are total 8 domains of SF-36 and its score range is from 0-100, the lower score means more disability and higher score means less disability
Measured: 7 days
Modified Medical Research Council (MMRC) Dyspnea Scale
During activity, the 5-item MMRC dyspnea scale was used to measure the severity of dyspnea. On this scale, the degree of dyspnea is rated from 0 (no dyspnea during ordinary activities or vigorous exercise) to 4 (dyspnea during routine activities). The patients were instructed to identify the number on the scale that most accurately represented their dyspnea after reading the descriptive comments. The reliability of the MMRC scale was computed with an intra-class correlation coefficient of 0.8, and the validity of the scale was thus established by using the perspectives of heart, lung, and nursing specialists through the use of the facial and qualitative content validity methodologies
Measured: 7 days
Secondary outcomes (4)
Heart Rate (HR)
Cardiac monitors in ICU/CCU settings will be used to measure heart rate (HR).
Measured: 7 days
Respiratory Rate (RR)
Cardiac monitors in ICU/ CCU will be used to measure respiratory rate (RR).
Measured: 7 Days
Blood Pressure (BP)
Cardiac monitors in ICU / CCU will be used to measure blood pressure (B.P).
Measured: 7 Days
Oxygen Saturation
Cardiac monitors in ICU / CCU will be used to measure Oxygen saturation.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start17 Jul 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CADStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iram Nawaz, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128849
- Sponsor's protocol ID
- REC/RCR & AHS/24/0351
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Organization WH. Cardiovascular diseases (CVDs). 2021.
Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/
PubMed 29939613Alexander JH, Smith PK. Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Sep 8;375(10):e22. doi: 10.1056/NEJMc1608042. No abstract available.
PubMed 27602683Dimopoulos S, Raidou V, Elaiopoulos D, Chatzivasiloglou F, Markantonaki D, Lyberopoulou E, Vasileiadis I, Marathias K, Nanas S, Karabinis A. Sonographic muscle mass assessment in patients after cardiac surgery. World J Cardiol. 2020 Jul 26;12(7):351-361. doi: 10.4330/wjc.v12.i7.351.
PubMed 32843937Cordeiro ALL, Mascarenhas HC, Landerson L, Araujo JDS, Borges DL, Melo TA, Guimaraes A, Petto J. Inspiratory Muscle Training Based on Anaerobic Threshold on the Functional Capacity of Patients After Coronary Artery Bypass Grafting: Clinical Trial. Braz J Cardiovasc Surg. 2020 Dec 1;35(6):942-949. doi: 10.21470/1678-9741-2019-0448.
PubMed 33113311Hossein Pour AH, Gholami M, Saki M, Birjandi M. The effect of inspiratory muscle training on fatigue and dyspnea in patients with heart failure: A randomized, controlled trial. Jpn J Nurs Sci. 2020 Apr;17(2):e12290. doi: 10.1111/jjns.12290. Epub 2019 Aug 19.
PubMed 31429207
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phase I Cardiac Rehabilitation With and Without Upper Limb Cycle Ergometer in Immediate Post-Operative Period of CABG
- ClinicalTrials.gov ID
- NCT07128849
- Acronym / sponsor ID
- REC/RCR & AHS/24/0351
- Conditions
- CAD
- Keywords
- phase I cardiac rehabilitation, upper limb cycle ergometer, post op period CABG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Aug 2025 (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 aim of the study is to investigate the effects of an upper limb cycle ergometer in phase I CABG patients. This will likely enhance various outcomes such as quality of life, dyspnea, functional outcome measure, cardiovascular parameters, and upper limb mobility. If utilized, the arm ergometer may contribute to improve upper limb strength and endurance. This could result in improving upper limb range of motion and reducing the risk of adhesive capsulitis. This study will positively impact society by reducing morbidity and mortality rates, healthcare costs and ultimately improves patient care.
Detailed description
The most often done major surgical surgery is coronary artery bypass grafting (CABG), a significant surgical procedure by using harvested venous or arterial conduit to bypass atheromatous obstructions in a patient's coronary arteries. Following heart surgery, patients face many complications that increases the duration of stay in the intensive care unit (ICU) and hospital, as well as the death rates following surgery. Following coronary artery bypass grafting (CABG), compliance with the cardiac rehabilitation (CR) regimen is essential. Cardiac rehabilitation in phase I include mobilization, respiratory and physical exercises, education on heart disease risk factors, and stress and anxiety management. An apparatus designed to help physiotherapists to increase muscle training is the upper limb cycle ergometer. It is possible to execute cyclical rotations with this equipment and utilize it for resistive, active, and passive patient exercise. Patients who have had coronary artery bypass surgery report improved physical and psychosocial functioning after engaging in arm ergometer workouts. The aim of this study is to investigate the effects of phase I cardiac rehabilitation on quality of life, dyspnea, functional outcome measure and cardiovascular parameters with and without upper limb cycle ergometer in immediate post-operative period of CABG.
A randomized clinical trial will be conducted at Combined Military Hospital Lahore. Non-probability convenient sampling technique will be applied on the patients according to the inclusion criteria. Patient will be randomly allocated through lottery method into group A and group B to collect data. Group A will receive upper limb exercise on arm ergometer lasting 5 min at 30 rpm (rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises, active upper and lower exercises (3 sets of 10 repetitions daily for 7 days); ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30 min), that will be progressed as patient condition till 7th day. Group B will receive same standard treatment as above, but without arm ergometer. The study will be completed within the time duration of ten months. Treatment evaluation of patients will be done after one week through 36-Item Short Form Survey (SF-36), Modified Medical Research Council Dyspnea scale, and Functional Independence Measure scale. Data will be analyzed using SPSS software version 27. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper limb exercise with arm ergometer | Experimental | Other: upper limb exercise with arm ergometerGroup A will receive upper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day |
| upper limb exercise with out arm ergometer | Active comparator | Other: upper limb exercise with out arm ergometerGroup B will receive standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Planned CABG patients
- 40-65 years
- Both male and female
- Hemodynamic stable patients
- Post extubation
Key exclusion criteria (7 listed)
- Patients suffering from pulmonary diseases and thyroid disorders
- Mechanical ventilation more than 24 hr
- Mean arterial pressure i.e, < 60 mmHg or > 140 mmHg and heart rate not more than 120bpm
- Having an orthopedic condition that makes the use of upper and lower extremity impossible.
- Who have neurological impairment influencing breathing rate and heart rate.
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 |
|---|---|---|
| upper limb exercise with arm ergometerupper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day | Other | upper limb exercise with arm ergometer |
| upper limb exercise with out arm ergometerstandard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day | Other | upper limb exercise with out arm ergometer |
Primary outcome
Functional independence Measure (FIM)
Time frame: 7 days
There are eighteen items in the FIM, and each item has a maximum score of seven points, a minimum score of one point, and and a maximum score of 126 points overall. The FIM has eighteen items, of which thirteen are used to test motor ADL (six self-care items, two sphincter control tasks, three transfer items, and two motor items), and the other five are used to assess cognitive ADL (two items for communication and three items for social cognition).
36- Item Short Form Survey Instrument
Time frame: 7 days
The SF-36 brief survey, which includes 36 items across eight categories of QOL, is a standardised tool for assessing generic health concepts. It includes ten items related to physical functioning, four items related to physical problems, five items related to general mental health, three items related to emotional problems, and two items related to relationships with family and friends. General health, which includes six items regarding the patient's personal opinion of health; physical pain, which includes 2 items about the patient's body pain intensity; and energy or vitality, which includes four things about vitality, exhaustion, and tiredness. There are total 8 domains of SF-36 and its score range is from 0-100, the lower score means more disability and higher score means less disability
Modified Medical Research Council (MMRC) Dyspnea Scale
Time frame: 7 days
During activity, the 5-item MMRC dyspnea scale was used to measure the severity of dyspnea. On this scale, the degree of dyspnea is rated from 0 (no dyspnea during ordinary activities or vigorous exercise) to 4 (dyspnea during routine activities). The patients were instructed to identify the number on the scale that most accurately represented their dyspnea after reading the descriptive comments. The reliability of the MMRC scale was computed with an intra-class correlation coefficient of 0.8, and the validity of the scale was thus established by using the perspectives of heart, lung, and nursing specialists through the use of the facial and qualitative content validity methodologies
4 secondary outcomes
Heart Rate (HR)
Time frame: 7 days
Respiratory Rate (RR)
Time frame: 7 Days
Blood Pressure (BP)
Time frame: 7 Days
Oxygen Saturation
Time frame: 7 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- BackgroundOrganization WH. Cardiovascular diseases (CVDs). 2021.
- Background: PubMed 29939613Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/
- Background: PubMed 27602683Alexander JH, Smith PK. Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Sep 8;375(10):e22. doi: 10.1056/NEJMc1608042. No abstract available.
- Background: PubMed 32843937Dimopoulos S, Raidou V, Elaiopoulos D, Chatzivasiloglou F, Markantonaki D, Lyberopoulou E, Vasileiadis I, Marathias K, Nanas S, Karabinis A. Sonographic muscle mass assessment in patients after cardiac surgery. World J Cardiol. 2020 Jul 26;12(7):351-361. doi: 10.4330/wjc.v12.i7.351.
- Background: PubMed 33113311Cordeiro ALL, Mascarenhas HC, Landerson L, Araujo JDS, Borges DL, Melo TA, Guimaraes A, Petto J. Inspiratory Muscle Training Based on Anaerobic Threshold on the Functional Capacity of Patients After Coronary Artery Bypass Grafting: Clinical Trial. Braz J Cardiovasc Surg. 2020 Dec 1;35(6):942-949. doi: 10.21470/1678-9741-2019-0448.
- Background: PubMed 31429207Hossein Pour AH, Gholami M, Saki M, Birjandi M. The effect of inspiratory muscle training on fatigue and dyspnea in patients with heart failure: A randomized, controlled trial. Jpn J Nurs Sci. 2020 Apr;17(2):e12290. doi: 10.1111/jjns.12290. Epub 2019 Aug 19.
- 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.
Iram Nawaz, Mphill 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 upper limb exercise with arm ergometer and upper limb exercise with out arm ergometer in people with CAD, 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 7 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, Phd (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?
Functional independence Measure (FIM) (time frame: 7 days). 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 NCT07128849, which also lists 6 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 19 Aug 2025.