Coronary Artery DiseaseNCT06844591
Effects of Conditioning Exercises and Resistance Interval Training on Post CABG Patients.
A study testing Conditioning Exercises/ Aerobic Interval Training and Resistance Interval Training in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Coronary artery disease (CAD) is a global health challenge influenced by diabetes, hypertension, and psychosocial stress, with women having a higher prevalence of Coronary microvascular disease. Promoting coronary collateral circulation offers an alternative coronary artery disease CAD treatment. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Conditioning Exercises/ Aerobic Interval Training and Resistance Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 40-55 years
- post-coronary artery bypass graft (CABG) patients both females and males were included
- New York Heart Association criteria IV
- Hemodynamically stable patient
Who cannot join
- Fall in New York Heart Association criteria II III;
- Hemoglobin < 9 g/dL;
- Patients with peripheral or vascular problems of the lower limb,
- Cognitive and/or mental disorders;
- Exercise limiting comorbidities (primarily orthopedic, neurological condition)
- Enrollment in another clinical trial involving physical training protocols.
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Cheema Heart complex, Hospital Gujranwala
Chak One Hundred Seventy-five Nine Left, Punjab Province, 52250
About this study
Official title: Comparison Between Conditioning Exercises and Resistance Interval Training on Quality of Life, Cardiorespiratory Fitness and Endurance in Post-CABG Patients
Coronary artery disease (CAD) is a global health challenge influenced by diabetes, hypertension, and psychosocial stress, with women having a higher prevalence of Coronary microvascular disease. Promoting coronary collateral circulation offers an alternative coronary artery disease CAD treatment. Invasive interventions like PCI and CABG aim to enhance coronary flow, restoring blood flow to ischemic myocardium. Post-CABG challenges include depression, anxiety, and factors affecting quality of life. Physiotherapy impacts heart rate variability, with virtual reality physiotherapy reducing both heart rate variability and hospital stay. Cardiac rehabilitation involves lifestyle changes, enhancing functional capacity, and supporting early recovery. Pre-operative respiratory muscle training improves outcomes. Acute high-intensity interval exercise and mild continuous exercise benefit exercise recovery. This research compares conditioning exercises and resistance interval training effects on post-CABG patients' well-being.
Read the detailed description
The randomized clinical trial will be conducted in physical therapy department at the District Headquarters (DHQ) in Gujranwala, employing a non-probability convenience sampling technique. The study aims to include individuals aged 40-55 years. Participants in phase IV cardiac rehabilitation. Both female and male will be included.Exclusion criteria involve individuals with another clinical trial involving physical protocols. Regular practice of physical exercise of more than 150min per week in last 3 months. Decompensated heart failure. Further exclusions encompass individuals who have had an acute myocardial infarction or cardiac surgery within the last 6 months, severe valvular heart diseases, uncontrolled cardiac arrhythmias, asymmetric septal hypertrophic cardiomyopathy with dynamic obstruction in the outflow pathway, musculoskeletal disorders limiting completion of the exercise program, and impaired cognitive status affecting understanding and adherence to the study protocol. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training. The difference in improvement before and after 6 weeks will be documented and compared.
- Conditions
- Coronary Artery Disease
- Being tested
- Conditioning Exercises/ Aerobic Interval Training, Resistance Interval Training
- Keywords
- Coronary Artery Bypass Grafting, Conditioning Therapy, Quality of Life, Resistance Training.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioning Exercises/ Aerobic Interval TrainingOther
Aerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group. A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program. The next activity round consisted of six x six-minute intervals of cycling and walking/uphill running on a treadmill at 60% to 85% of THR, separated by three minutes of rest/recovery. A ten-to fifteen-minute cool- down period followed the session.
Resistance Interval TrainingOther
Resistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists. Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level. Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider. The workout lasted thirty to forty minutes in total. To fit the training load, resistance and intensity were gradually raised. For six weeks, this supervised training program was adhered to three times a week on alternate days
| Study group | Role | What they receive |
|---|---|---|
| Conditioning Exercise Group | Experimental | Aerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group. A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program. Participants will complete a well-tested Performa. Basic parameters will be collected through the outcome measure tool. The difference in improvement before and after 6 weeks will be documented and compared. Receives: Other: Conditioning Exercises/ Aerobic Interval Training |
| Resistance Interval Training Group | Experimental | Resistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists. Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level. Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider. The workout lasted thirty to forty minutes in total. To fit the training load, resistance and intensity were gradually raised. For six weeks, this supervised training program was adhered to three times a week on alternate days. The difference in improvement before and after 6 weeks will be documented and compared. Receives: Other: Resistance Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Questionnaire
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used for quality of life, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. The 36-Item Short Form Survey (SF-36) will be used which is a self-reported measure of health that covers eight domains of health.
Measured: 6 weeks
6-minute walk test
The 6-minute walk test (6MWT) will be used for cardiorespiratory fitness, to measure the distance walked in a specified time and reflect the functional exercise level. The primary measurement is 6-min walk distance (6MWD), but during the 6MWT data can also be collected about the patient's blood oxygen saturation and perception of dyspnea during exertion. When conducting the 6MWT do not walk with the patient and do not assist the patient in carrying or pulling his or her supplemental oxygen. The patient should walk alone, not with other patients. Do not use a treadmill on which the patient adjusts the speed and/or the slope. Do not use an oval or circular track. An increase in the distance walked indicates improvement in basic mobility. Post training a difference of at least 45m should be observed for the 6 minutes' walk test to be sure that a "real" change in the patient's condition
Measured: 6 weeks
30-second stand chair
For endurance, the sit-to-stand (STS) test measures the number of times a person can stand up from a chair in a given time (30 seconds, 1 minute, or 5 repetitions). The 30 Second Sit to Stand Test is also known as 30 Second Chair Stand Test (30CST), was initially designed for testing leg strength and endurance in adults. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre- determined number of repetitions.
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 posted25 Feb 2025
- Study start9 Mar 2024
- Primary completion30 May 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Participants will complete a well-tested Performa. Basic parameters will be collected through the outcome measure tool. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training for 6 weeks. The difference in improvement before and after 6 weeks will be documented and compared.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat ul Ain, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844591
- Sponsor's protocol ID
- REC/RCR & AHS/24/0322 Rubab
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terada T, Cotie L, Noda T, Vidal-Almela S, O'Neill CD, Reed JL. Effects of High-Intensity Interval Training, Moderate-to-Vigorous Intensity Continuous Training, and Nordic Walking on Functional Fitness in Patients with Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 May 1;43(3):224-226. doi: 10.1097/HCR.0000000000000775. Epub 2023 Mar 2. No abstract available.
PubMed 36857093Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Anabolic and Inflammatory Response to High- and Low-Load Resistance Training in Patients with Coronary Artery Disease: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2023 Jul 1;43(4):307-309. doi: 10.1097/HCR.0000000000000783. Epub 2023 Mar 6. No abstract available.
PubMed 36867715McGregor G, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, McGuire S, Prosser J, Fiassam O, Hee SW, Hamborg T, Banerjee P, Hartfiel N, Charles JM, Edwards RT, Drane A, Ali D, Osman F, He H, Lachlan T, Haykowsky MJ, Ingle L, Shave R. High-intensity interval training in cardiac rehabilitation: a multi-centre randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):745-755. doi: 10.1093/eurjpc/zwad039.
PubMed 36753063Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Assessment of the Early Disabling Effects of Coronary Artery Bypass Graft Surgery Using Direct Measures of Physical Function. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):28-33. doi: 10.1097/HCR.0000000000000587.
PubMed 33797459Kristiansen J, Sjuretharson T, Grove EL, Rasmussen J, Kristensen SD, Hvas AM, Mohr M. Feasibility and impact of whole-body high-intensity interval training in patients with stable coronary artery disease: a randomised controlled trial. Sci Rep. 2022 Oct 14;12(1):17295. doi: 10.1038/s41598-022-21655-w.
PubMed 36241898
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conditioning Exercises and Resistance Interval Training on Quality of Life, Cardiorespiratory Fitness and Endurance in Post-CABG Patients
- ClinicalTrials.gov ID
- NCT06844591
- Acronym / sponsor ID
- REC/RCR & AHS/24/0322 Rubab
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Grafting, Conditioning Therapy, Quality of Life, Resistance Training.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 25 Feb 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.
Coronary artery disease (CAD) is a global health challenge influenced by diabetes, hypertension, and psychosocial stress, with women having a higher prevalence of Coronary microvascular disease. Promoting coronary collateral circulation offers an alternative coronary artery disease CAD treatment. Invasive interventions like PCI and CABG aim to enhance coronary flow, restoring blood flow to ischemic myocardium. Post-CABG challenges include depression, anxiety, and factors affecting quality of life. Physiotherapy impacts heart rate variability, with virtual reality physiotherapy reducing both heart rate variability and hospital stay. Cardiac rehabilitation involves lifestyle changes, enhancing functional capacity, and supporting early recovery. Pre-operative respiratory muscle training improves outcomes. Acute high-intensity interval exercise and mild continuous exercise benefit exercise recovery. This research compares conditioning exercises and resistance interval training effects on post-CABG patients' well-being.
Detailed description
The randomized clinical trial will be conducted in physical therapy department at the District Headquarters (DHQ) in Gujranwala, employing a non-probability convenience sampling technique. The study aims to include individuals aged 40-55 years. Participants in phase IV cardiac rehabilitation. Both female and male will be included.Exclusion criteria involve individuals with another clinical trial involving physical protocols. Regular practice of physical exercise of more than 150min per week in last 3 months. Decompensated heart failure. Further exclusions encompass individuals who have had an acute myocardial infarction or cardiac surgery within the last 6 months, severe valvular heart diseases, uncontrolled cardiac arrhythmias, asymmetric septal hypertrophic cardiomyopathy with dynamic obstruction in the outflow pathway, musculoskeletal disorders limiting completion of the exercise program, and impaired cognitive status affecting understanding and adherence to the study protocol. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training. The difference in improvement before and after 6 weeks will be documented and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will complete a well-tested Performa. Basic parameters will be collected through the outcome measure tool. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training for 6 weeks. The difference in improvement before and after 6 weeks will be documented and compared.
| Arm | Type | Receives |
|---|---|---|
| Conditioning Exercise Group | Experimental | Other: Conditioning Exercises/ Aerobic Interval TrainingAerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group. A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program. Participants will complete a well-tested Performa. Basic parameters will be collected through the outcome measure tool. The difference in improvement before and after 6 weeks will be documented and compared. |
| Resistance Interval Training Group | Experimental | Other: Resistance Interval TrainingResistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists. Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level. Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider. The workout lasted thirty to forty minutes in total. To fit the training load, resistance and intensity were gradually raised. For six weeks, this supervised training program was adhered to three times a week on alternate days. The difference in improvement before and after 6 weeks will be documented and compared. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 40-55 years
- post-coronary artery bypass graft (CABG) patients both females and males were included
- New York Heart Association criteria IV
- Hemodynamically stable patient
Key exclusion criteria (7 listed)
- Fall in New York Heart Association criteria II III;
- Hemoglobin < 9 g/dL;
- Patients with peripheral or vascular problems of the lower limb,
- Cognitive and/or mental disorders;
- Exercise limiting comorbidities (primarily orthopedic, neurological condition)
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 |
|---|---|---|
| Conditioning Exercises/ Aerobic Interval TrainingAerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group. A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program. The next activity round consisted of six x six-minute intervals of cycling and walking/uphill running on a treadmill at 60% to 85% of THR, separated by three minutes of rest/recovery. A ten-to fifteen-minute cool- down period followed the session. | Other | Conditioning Exercise Group |
| Resistance Interval TrainingResistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists. Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level. Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider. The workout lasted thirty to forty minutes in total. To fit the training load, resistance and intensity were gradually raised. For six weeks, this supervised training program was adhered to three times a week on alternate days | Other | Resistance Interval Training Group |
Primary outcome
SF-36 Questionnaire
Time frame: 6 weeks
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used for quality of life, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. The 36-Item Short Form Survey (SF-36) will be used which is a self-reported measure of health that covers eight domains of health.
6-minute walk test
Time frame: 6 weeks
The 6-minute walk test (6MWT) will be used for cardiorespiratory fitness, to measure the distance walked in a specified time and reflect the functional exercise level. The primary measurement is 6-min walk distance (6MWD), but during the 6MWT data can also be collected about the patient's blood oxygen saturation and perception of dyspnea during exertion. When conducting the 6MWT do not walk with the patient and do not assist the patient in carrying or pulling his or her supplemental oxygen. The patient should walk alone, not with other patients. Do not use a treadmill on which the patient adjusts the speed and/or the slope. Do not use an oval or circular track. An increase in the distance walked indicates improvement in basic mobility. Post training a difference of at least 45m should be observed for the 6 minutes' walk test to be sure that a "real" change in the patient's condition
30-second stand chair
Time frame: 6 Weeks
For endurance, the sit-to-stand (STS) test measures the number of times a person can stand up from a chair in a given time (30 seconds, 1 minute, or 5 repetitions). The 30 Second Sit to Stand Test is also known as 30 Second Chair Stand Test (30CST), was initially designed for testing leg strength and endurance in adults. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre- determined number of repetitions.
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 25 Feb 2025.
- Background: PubMed 36857093Terada T, Cotie L, Noda T, Vidal-Almela S, O'Neill CD, Reed JL. Effects of High-Intensity Interval Training, Moderate-to-Vigorous Intensity Continuous Training, and Nordic Walking on Functional Fitness in Patients with Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 May 1;43(3):224-226. doi: 10.1097/HCR.0000000000000775. Epub 2023 Mar 2. No abstract available.
- Background: PubMed 36867715Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Anabolic and Inflammatory Response to High- and Low-Load Resistance Training in Patients with Coronary Artery Disease: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2023 Jul 1;43(4):307-309. doi: 10.1097/HCR.0000000000000783. Epub 2023 Mar 6. No abstract available.
- Background: PubMed 36753063McGregor G, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, McGuire S, Prosser J, Fiassam O, Hee SW, Hamborg T, Banerjee P, Hartfiel N, Charles JM, Edwards RT, Drane A, Ali D, Osman F, He H, Lachlan T, Haykowsky MJ, Ingle L, Shave R. High-intensity interval training in cardiac rehabilitation: a multi-centre randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):745-755. doi: 10.1093/eurjpc/zwad039.
- Background: PubMed 33797459Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Assessment of the Early Disabling Effects of Coronary Artery Bypass Graft Surgery Using Direct Measures of Physical Function. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):28-33. doi: 10.1097/HCR.0000000000000587.
- Background: PubMed 36241898Kristiansen J, Sjuretharson T, Grove EL, Rasmussen J, Kristensen SD, Hvas AM, Mohr M. Feasibility and impact of whole-body high-intensity interval training in patients with stable coronary artery disease: a randomised controlled trial. Sci Rep. 2022 Oct 14;12(1):17295. doi: 10.1038/s41598-022-21655-w.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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 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 Conditioning Exercises/ Aerobic Interval Training and Resistance Interval Training in people with Coronary Artery Disease, 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 4 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: finished, as of the sponsor's last update on 25 Feb 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?
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?
SF-36 Questionnaire (time frame: 6 weeks). 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 NCT06844591, which also lists 5 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 25 Feb 2025.