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NCT Number: NCT06490250

Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa (IUC) Cardiology Institute

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Rengin Demir, Prof

CONTACT

[email protected]

02124592000 ext. 50114

Rengin Demir, Prof

CONTACT

[email protected]

02124592000 ext. 50115

Rengin Demir, Prof

PRINCIPAL_INVESTIGATOR

Veysel Oktay, Assoc Prof

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Inspiratory Muscle Training

Other

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 Exercise

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pulmonary Function Tests (PFT)

    Time frame: Change from Baseline at 8 weeks

    Pulmonary function tests will be conducted using a spirometer, following the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria.

  2. Maximal Inspiratory Pressure (MIP)

    Time frame: Change from Baseline at 8 weeks

    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.

  3. Nitric Oxide Levels

    Time frame: Change from Baseline at 8 weeks

    Nitric oxide levels' measurements will be performed with a fractional exhaled nitric oxide (FeNO) device.

  4. Minnesota Living with Heart Failure Questionnaire

    Time frame: Change from Baseline at 8 weeks

    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.

  5. New York Heart Association (NYHA) Classification

    Time frame: Change from Baseline at 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rengin Demir, Prof

CONTACT

[email protected]

+902124592000 ext. 50114

Veysel Oktay, Assoc Prof

CONTACT

[email protected]

+902124592000 ext. 50114

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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