Hypertrophic CardiomyopathyNCT06490250
Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients
A study testing Inspiratory Muscle Training and Baduanjin Exercise in people with Hypertrophic Cardiomyopathy and Heart Diseases, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study aims to compare the effects of inspiratory muscle training and Baduanjin exercises on pulmonary function, exercise capacity, and quality of life in patients with hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Heart Diseases
- What is being tested?
- Inspiratory Muscle Training and Baduanjin Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myocardial thickness in any region of the left ventricle is 15 mm or more on echocardiography or cardiac MRI
- Clinically and hemodynamically stable (patients with NYHA Class I and II)
- Patients over 18 years of age
- Patients who provide informed consent
Who cannot join
- Acute decompensated heart failure
- Decreased ejection fraction (<40%)
- Unstable angina pectoris
- Significant coronary artery disease (CAD)
- Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/m²)
- Uncontrolled hypertension (despite medication)
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- Severe valve disease (moderate-severe aortic stenosis, advanced mitral regurgitation)
- Severe neurological disorders causing autonomic dysfunction
- Cognitive impairment that prevents communication
- Recent fractures, osteoporosis, presence of tumors, pregnancy, or back and spine problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa (IUC) Cardiology Institute
Istanbul
Rengin Demir, Prof, 02124592000 ext. 50114, rengindemir@yahoo.com
Rengin Demir, Prof, 02124592000 ext. 50115, kardiyolojienstitusu@iuc.edu.tr
About this study
Official title: Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises on Pulmonary Function, Exercise Capacity and Quality of Life in Patients With Hypertrophic Cardiomyopathy
The study aims to compare the effects of inspiratory muscle training and Baduanjin exercises on pulmonary function, exercise capacity, and quality of life in patients with hypertrophic cardiomyopathy. By investigating these interventions, the investigators seek to introduce novel approaches that can enhance pulmonary function, exercise capacity, and overall quality of life for these patients.
In the study, which will involve three groups-the control group, the inspiratory muscle training (IMT) group, and the Baduanjin group-it was calculated that a total of 51 patients, with 17 in each group (n = 17), should be included.
Read more
The IMT group will use an inspiratory muscle training device twice a day, every day of the week, for 15 minutes. This training will continue for 8 weeks, with supervision once a week and unsupervised sessions on the other days.
The Baduanjin group will participate in a 50-minute exercise program, which includes a 10-minute warm-up, a 30-minute routine of eight separate movements, and a 10-minute cool-down. This will occur three times a week (twice in person and once online) for 8 weeks.
Read the detailed description
Hypertrophic cardiomyopathy (HCM) is characterized by a left ventricular wall thickness exceeding 15 millimeters (mm), as assessed by echocardiography and cardiac magnetic resonance imaging (MRI). It is a common genetic heart disease worldwide, known to cause left ventricular outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, and autonomic dysfunction (PubMed identification number (ID): 29655825, 28912181, 24998133, 30110588, 33229115).
Many patients with HCM are asymptomatic, and the condition is often identified incidentally during routine screening. Symptomatic patients may experience dyspnea on exertion, chest pain, syncope, or presyncope (PubMed ID:11886323). Even when left ventricular systolic function is preserved, patients frequently develop symptoms such as dyspnea and fatigue, leading to exercise intolerance in the majority (PubMed ID:10913477).
HCM is a heterogeneous disease with a varied clinical course. In addition to these symptoms, patients may also face decreased exercise capacity and reduced quality of life (PubMed ID:19253387, 9326995). Furthermore, despite the well-established cardiovascular and overall health benefits of regular physical activity, many patients with HCM exhibit a high prevalence of physical inactivity (PubMed ID: 23340032, 27547438).
Studies on inspiratory muscle training have demonstrated its benefits in improving respiratory function, respiratory muscle strength, quality of life, and exercise capacity across various patient groups including chronic obstructive pulmonary disease, cystic fibrosis, spinal cord injury, and heart failure. It also helps alleviate symptoms of dyspnea and fatigue (PubMed ID:32209709, 30827470, 32936904, 31429207, 31937553). Additionally, inspiratory muscle training has been shown to enhance physical activity levels in different patient cohorts (PubMed ID: 17534784).
Research indicates that Baduanjin exercises can serve as a complementary and alternative treatment for cardiovascular patients, improving clinical outcomes and reducing adverse cardiovascular events (PubMed ID:30059552). Furthermore, studies have highlighted their positive effects on quality of life and exercise capacity in diverse populations such as healthy individuals and those with conditions like heart failure, Parkinson's disease, osteoarthritis, and chronic fatigue syndrome, while also mitigating fatigue symptoms (PubMed ID: 36436262, 19051349, 27627031, 23001463, 18315512, 26083663, 25610473, 27938498).
Based on existing literature, the investigators believe that inspiratory muscle training and Baduanjin exercises could potentially benefit patients with HCM by alleviating associated symptoms. However, there is a notable scarcity of studies investigating different exercise modalities in HCM patients. To the investigators' knowledge, no studies have specifically examined the effects of inspiratory muscle training or Baduanjin exercises in this population.
The study aims to fill this gap by being the first to compare the impacts of inspiratory muscle training and Baduanjin exercises on pulmonary function, exercise capacity, and quality of life in patients with HCM. Through this research, the investigators seek to introduce new approaches that enhance pulmonary function, exercise capacity, and overall quality of life for these patients.
- Conditions
- Hypertrophic Cardiomyopathy, Heart Diseases
- Being tested
- Inspiratory Muscle Training, Baduanjin Exercise
- Keywords
- Exercise capacity, Pulmonary function, Quality of life
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
The IMT group will use an inspiratory muscle training device twice a day, every day of the week, for 15 minutes. This training will continue for 8 weeks, with supervision once a week and unsupervised sessions on the other day
Baduanjin ExerciseOther
The Baduanjin group will participate in a 50-minute exercise program, which includes a 10-minute warm-up, a 30-minute routine of eight separate movements, and a 10-minute cool-down. This will occur three times a week (twice in person and once online) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) Group | Experimental | The inspiratory muscle training group will participate in the respiratory exercise program with the IMT device. Receives: Other: Inspiratory Muscle Training |
| Baduanjin Exercise Group | Experimental | The Baduanjin group will participate in the Baduanjin exercise program, which includes 8 movements. Receives: Other: Baduanjin Exercise |
| Control Group | No intervention | The control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Six-Minute Walk Test (6MWT)
Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society. Functional exercise capacity will be evaluated with the six-minute walk test. Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and O2 saturation will be measured with pulse oximetry, and dyspnea and fatigue levels will be determined according to the Modified Borg scale.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (5)
Pulmonary Function Tests (PFT)
Pulmonary function tests will be conducted using a spirometer, following the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria.
Measured: Change from Baseline at 8 weeks
Maximal Inspiratory Pressure (MIP)
Inspiratory muscle strength will be measured using a portable electronic oral pressure measurement device (MicroRPM; Micro Medical, UK). According to the recommendations of the American Thoracic Society and the European Respiratory Society, a maximum of five maneuvers will be performed, with 1-minute intervals between them. For maximum inspiratory pressure (MIP) measurement, patients will be seated and will first exhale maximally using a nose clip, then be asked to inhale maximally through a mouthpiece for at least 2 seconds. The results will be recorded in centimetres of water (cmH2O) and as a percentage of the expected value. Maneuvers will be considered satisfactory when a change of less than 10% is observed between three measurements, and the highest value will be recorded.
Measured: Change from Baseline at 8 weeks
Nitric Oxide Levels
Nitric oxide levels' measurements will be performed with a fractional exhaled nitric oxide (FeNO) device.
Measured: Change from Baseline at 8 weeks
Minnesota Living with Heart Failure Questionnaire
The Minnesota Living with Heart Failure Questionnaire will be used to assess the quality of life. This questionnaire evaluates how much heart failure has affected the patient's life over the past month (4 weeks). Patients circle a number from 0 to 5 next to each question to indicate the impact on their life, with 0 meaning no impact. The survey consists of 21 questions.
Measured: Change from Baseline at 8 weeks
New York Heart Association (NYHA) Classification
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start25 Oct 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- Three groups with control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Yurtseven, Istanbul University - Cerrahpasa
- Investigators
- Rengin Demir, Prof, Study director, Istanbul University-Cerrahpasa (IUC) Cardiology InstituteVeysel Oktay, Assoc Prof, Study chair, Istanbul University-Cerrahpasa (IUC) Cardiology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490250
- Sponsor's protocol ID
- IUC-FTR-MY-01
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geske JB, Ommen SR, Gersh BJ. Hypertrophic Cardiomyopathy: Clinical Update. JACC Heart Fail. 2018 May;6(5):364-375. doi: 10.1016/j.jchf.2018.02.010. Epub 2018 Apr 11.
PubMed 29655825Marian AJ, Braunwald E. Hypertrophic Cardiomyopathy: Genetics, Pathogenesis, Clinical Manifestations, Diagnosis, and Therapy. Circ Res. 2017 Sep 15;121(7):749-770. doi: 10.1161/CIRCRESAHA.117.311059.
PubMed 28912181Maron BJ, Ommen SR, Semsarian C, Spirito P, Olivotto I, Maron MS. Hypertrophic cardiomyopathy: present and future, with translation into contemporary cardiovascular medicine. J Am Coll Cardiol. 2014 Jul 8;64(1):83-99. doi: 10.1016/j.jacc.2014.05.003.
PubMed 24998133Maron BJ. Clinical Course and Management of Hypertrophic Cardiomyopathy. N Engl J Med. 2018 Aug 16;379(7):655-668. doi: 10.1056/NEJMra1710575. No abstract available.
PubMed 30110588Ommen SR, Mital S, Burke MA, Day SM, Deswal A, Elliott P, Evanovich LL, Hung J, Joglar JA, Kantor P, Kimmelstiel C, Kittleson M, Link MS, Maron MS, Martinez MW, Miyake CY, Schaff HV, Semsarian C, Sorajja P. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2020 Dec 22;76(25):3022-3055. doi: 10.1016/j.jacc.2020.08.044. Epub 2020 Nov 20.
PubMed 33229115Maron BJ. Hypertrophic cardiomyopathy: a systematic review. JAMA. 2002 Mar 13;287(10):1308-20. doi: 10.1001/jama.287.10.1308.
PubMed 11886323Sharma S, Elliott P, Whyte G, Jones S, Mahon N, Whipp B, McKenna WJ. Utility of cardiopulmonary exercise in the assessment of clinical determinants of functional capacity in hypertrophic cardiomyopathy. Am J Cardiol. 2000 Jul 15;86(2):162-8. doi: 10.1016/s0002-9149(00)00854-7.
PubMed 10913477Christiaans I, van Langen IM, Birnie E, Bonsel GJ, Wilde AA, Smets EM. Quality of life and psychological distress in hypertrophic cardiomyopathy mutation carriers: a cross-sectional cohort study. Am J Med Genet A. 2009 Feb 15;149A(4):602-12. doi: 10.1002/ajmg.a.32710.
PubMed 19253387Cox S, O'Donoghue AC, McKenna WJ, Steptoe A. Health related quality of life and psychological wellbeing in patients with hypertrophic cardiomyopathy. Heart. 1997 Aug;78(2):182-7. doi: 10.1136/hrt.78.2.182.
PubMed 9326995Reineck E, Rolston B, Bragg-Gresham JL, Salberg L, Baty L, Kumar S, Wheeler MT, Ashley E, Saberi S, Day SM. Physical activity and other health behaviors in adults with hypertrophic cardiomyopathy. Am J Cardiol. 2013 Apr 1;111(7):1034-9. doi: 10.1016/j.amjcard.2012.12.018. Epub 2013 Jan 19.
PubMed 23340032Sweeting J, Ingles J, Timperio A, Patterson J, Ball K, Semsarian C. Physical activity in hypertrophic cardiomyopathy: prevalence of inactivity and perceived barriers. Open Heart. 2016 Jul 20;3(2):e000484. doi: 10.1136/openhrt-2016-000484. eCollection 2016.
PubMed 27547438Figueiredo RIN, Azambuja AM, Cureau FV, Sbruzzi G. Inspiratory Muscle Training in COPD. Respir Care. 2020 Aug;65(8):1189-1201. doi: 10.4187/respcare.07098. Epub 2020 Mar 24.
PubMed 32209709Zeren M, Cakir E, Gurses HN. Effects of inspiratory muscle training on postural stability, pulmonary function and functional capacity in children with cystic fibrosis: A randomised controlled trial. Respir Med. 2019 Mar;148:24-30. doi: 10.1016/j.rmed.2019.01.013. Epub 2019 Jan 28.
PubMed 30827470Azambuja ACM, de Oliveira LZ, Sbruzzi G. Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. Phys Ther. 2020 Dec 7;100(12):2099-2109. doi: 10.1093/ptj/pzaa171.
PubMed 32936904Hossein 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises on Pulmonary Function, Exercise Capacity and Quality of Life in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06490250
- Acronym / sponsor ID
- IUC-FTR-MY-01
- Conditions
- Hypertrophic Cardiomyopathy, Heart Diseases
- Keywords
- Exercise capacity, Pulmonary function, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Jul 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.
The study aims to compare the effects of inspiratory muscle training and Baduanjin exercises on pulmonary function, exercise capacity, and quality of life in patients with hypertrophic cardiomyopathy. By investigating these interventions, the investigators seek to introduce novel approaches that can enhance pulmonary function, exercise capacity, and overall quality of life for these patients.
In the study, which will involve three groups-the control group, the inspiratory muscle training (IMT) group, and the Baduanjin group-it was calculated that a total of 51 patients, with 17 in each group (n = 17), should be included.
The IMT group will use an inspiratory muscle training device twice a day, every day of the week, for 15 minutes. This training will continue for 8 weeks, with supervision once a week and unsupervised sessions on the other days.
The Baduanjin group will participate in a 50-minute exercise program, which includes a 10-minute warm-up, a 30-minute routine of eight separate movements, and a 10-minute cool-down. This will occur three times a week (twice in person and once online) for 8 weeks.
Detailed description
Hypertrophic cardiomyopathy (HCM) is characterized by a left ventricular wall thickness exceeding 15 millimeters (mm), as assessed by echocardiography and cardiac magnetic resonance imaging (MRI). It is a common genetic heart disease worldwide, known to cause left ventricular outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, and autonomic dysfunction (PubMed identification number (ID): 29655825, 28912181, 24998133, 30110588, 33229115).
Many patients with HCM are asymptomatic, and the condition is often identified incidentally during routine screening. Symptomatic patients may experience dyspnea on exertion, chest pain, syncope, or presyncope (PubMed ID:11886323). Even when left ventricular systolic function is preserved, patients frequently develop symptoms such as dyspnea and fatigue, leading to exercise intolerance in the majority (PubMed ID:10913477).
HCM is a heterogeneous disease with a varied clinical course. In addition to these symptoms, patients may also face decreased exercise capacity and reduced quality of life (PubMed ID:19253387, 9326995). Furthermore, despite the well-established cardiovascular and overall health benefits of regular physical activity, many patients with HCM exhibit a high prevalence of physical inactivity (PubMed ID: 23340032, 27547438).
Studies on inspiratory muscle training have demonstrated its benefits in improving respiratory function, respiratory muscle strength, quality of life, and exercise capacity across various patient groups including chronic obstructive pulmonary disease, cystic fibrosis, spinal cord injury, and heart failure. It also helps alleviate symptoms of dyspnea and fatigue (PubMed ID:32209709, 30827470, 32936904, 31429207, 31937553). Additionally, inspiratory muscle training has been shown to enhance physical activity levels in different patient cohorts (PubMed ID: 17534784).
Research indicates that Baduanjin exercises can serve as a complementary and alternative treatment for cardiovascular patients, improving clinical outcomes and reducing adverse cardiovascular events (PubMed ID:30059552). Furthermore, studies have highlighted their positive effects on quality of life and exercise capacity in diverse populations such as healthy individuals and those with conditions like heart failure, Parkinson's disease, osteoarthritis, and chronic fatigue syndrome, while also mitigating fatigue symptoms (PubMed ID: 36436262, 19051349, 27627031, 23001463, 18315512, 26083663, 25610473, 27938498).
Based on existing literature, the investigators believe that inspiratory muscle training and Baduanjin exercises could potentially benefit patients with HCM by alleviating associated symptoms. However, there is a notable scarcity of studies investigating different exercise modalities in HCM patients. To the investigators' knowledge, no studies have specifically examined the effects of inspiratory muscle training or Baduanjin exercises in this population.
The study aims to fill this gap by being the first to compare the impacts of inspiratory muscle training and Baduanjin exercises on pulmonary function, exercise capacity, and quality of life in patients with HCM. Through this research, the investigators seek to introduce new approaches that enhance pulmonary function, exercise capacity, and overall quality of life for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with control group
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) Group | Experimental | Other: Inspiratory Muscle TrainingThe inspiratory muscle training group will participate in the respiratory exercise program with the IMT device. |
| Baduanjin Exercise Group | Experimental | Other: Baduanjin ExerciseThe Baduanjin group will participate in the Baduanjin exercise program, which includes 8 movements. |
| Control Group | No intervention | –The control group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Myocardial thickness in any region of the left ventricle is 15 mm or more on echocardiography or cardiac MRI
- Clinically and hemodynamically stable (patients with NYHA Class I and II)
- Patients over 18 years of age
- Patients who provide informed consent
Key exclusion criteria (10 listed)
- Acute decompensated heart failure
- Decreased ejection fraction (<40%)
- Unstable angina pectoris
- Significant coronary artery disease (CAD)
- Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/m²)
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 |
|---|---|---|
| Inspiratory Muscle TrainingThe IMT group will use an inspiratory muscle training device twice a day, every day of the week, for 15 minutes. This training will continue for 8 weeks, with supervision once a week and unsupervised sessions on the other day | Other | Inspiratory Muscle Training (IMT) Group |
| Baduanjin ExerciseThe Baduanjin group will participate in a 50-minute exercise program, which includes a 10-minute warm-up, a 30-minute routine of eight separate movements, and a 10-minute cool-down. This will occur three times a week (twice in person and once online) for 8 weeks. | Other | Baduanjin Exercise Group |
Primary outcome
The Six-Minute Walk Test (6MWT)
Time frame: Change from Baseline at 8 weeks
Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society. Functional exercise capacity will be evaluated with the six-minute walk test. Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and O2 saturation will be measured with pulse oximetry, and dyspnea and fatigue levels will be determined according to the Modified Borg scale.
5 secondary outcomes
Pulmonary Function Tests (PFT)
Time frame: Change from Baseline at 8 weeks
Maximal Inspiratory Pressure (MIP)
Time frame: Change from Baseline at 8 weeks
Nitric Oxide Levels
Time frame: Change from Baseline at 8 weeks
Minnesota Living with Heart Failure Questionnaire
Time frame: Change from Baseline at 8 weeks
New York Heart Association (NYHA) Classification
Time frame: Change from Baseline at 8 weeks
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 15 Jun 2025.
- Background: PubMed 29655825Geske JB, Ommen SR, Gersh BJ. Hypertrophic Cardiomyopathy: Clinical Update. JACC Heart Fail. 2018 May;6(5):364-375. doi: 10.1016/j.jchf.2018.02.010. Epub 2018 Apr 11.
- Background: PubMed 28912181Marian AJ, Braunwald E. Hypertrophic Cardiomyopathy: Genetics, Pathogenesis, Clinical Manifestations, Diagnosis, and Therapy. Circ Res. 2017 Sep 15;121(7):749-770. doi: 10.1161/CIRCRESAHA.117.311059.
- Background: PubMed 24998133Maron BJ, Ommen SR, Semsarian C, Spirito P, Olivotto I, Maron MS. Hypertrophic cardiomyopathy: present and future, with translation into contemporary cardiovascular medicine. J Am Coll Cardiol. 2014 Jul 8;64(1):83-99. doi: 10.1016/j.jacc.2014.05.003.
- Background: PubMed 30110588Maron BJ. Clinical Course and Management of Hypertrophic Cardiomyopathy. N Engl J Med. 2018 Aug 16;379(7):655-668. doi: 10.1056/NEJMra1710575. No abstract available.
- Background: PubMed 33229115Ommen SR, Mital S, Burke MA, Day SM, Deswal A, Elliott P, Evanovich LL, Hung J, Joglar JA, Kantor P, Kimmelstiel C, Kittleson M, Link MS, Maron MS, Martinez MW, Miyake CY, Schaff HV, Semsarian C, Sorajja P. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2020 Dec 22;76(25):3022-3055. doi: 10.1016/j.jacc.2020.08.044. Epub 2020 Nov 20.
- Background: PubMed 11886323Maron BJ. Hypertrophic cardiomyopathy: a systematic review. JAMA. 2002 Mar 13;287(10):1308-20. doi: 10.1001/jama.287.10.1308.
- Background: PubMed 10913477Sharma S, Elliott P, Whyte G, Jones S, Mahon N, Whipp B, McKenna WJ. Utility of cardiopulmonary exercise in the assessment of clinical determinants of functional capacity in hypertrophic cardiomyopathy. Am J Cardiol. 2000 Jul 15;86(2):162-8. doi: 10.1016/s0002-9149(00)00854-7.
- Background: PubMed 19253387Christiaans I, van Langen IM, Birnie E, Bonsel GJ, Wilde AA, Smets EM. Quality of life and psychological distress in hypertrophic cardiomyopathy mutation carriers: a cross-sectional cohort study. Am J Med Genet A. 2009 Feb 15;149A(4):602-12. doi: 10.1002/ajmg.a.32710.
- Background: PubMed 9326995Cox S, O'Donoghue AC, McKenna WJ, Steptoe A. Health related quality of life and psychological wellbeing in patients with hypertrophic cardiomyopathy. Heart. 1997 Aug;78(2):182-7. doi: 10.1136/hrt.78.2.182.
- Background: PubMed 23340032Reineck E, Rolston B, Bragg-Gresham JL, Salberg L, Baty L, Kumar S, Wheeler MT, Ashley E, Saberi S, Day SM. Physical activity and other health behaviors in adults with hypertrophic cardiomyopathy. Am J Cardiol. 2013 Apr 1;111(7):1034-9. doi: 10.1016/j.amjcard.2012.12.018. Epub 2013 Jan 19.
- Background: PubMed 27547438Sweeting J, Ingles J, Timperio A, Patterson J, Ball K, Semsarian C. Physical activity in hypertrophic cardiomyopathy: prevalence of inactivity and perceived barriers. Open Heart. 2016 Jul 20;3(2):e000484. doi: 10.1136/openhrt-2016-000484. eCollection 2016.
- Background: PubMed 32209709Figueiredo RIN, Azambuja AM, Cureau FV, Sbruzzi G. Inspiratory Muscle Training in COPD. Respir Care. 2020 Aug;65(8):1189-1201. doi: 10.4187/respcare.07098. Epub 2020 Mar 24.
- 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.
Rengin Demir, Prof study director
Istanbul University-Cerrahpasa (IUC) Cardiology Institute
Veysel Oktay, Assoc Prof study chair
Istanbul University-Cerrahpasa (IUC) Cardiology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training and Baduanjin Exercise in people with Hypertrophic Cardiomyopathy and Heart Diseases, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 15 Jun 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 Turkey (Türkiye). 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 Rengin Demir, Prof (+902124592000 ext. 50114, rengindemir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Six-Minute Walk Test (6MWT) (time frame: Change from Baseline at 8 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 NCT06490250, which also lists 26 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 15 Jun 2025.