Clinical trial NCT06490250: Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Heart Diseases
Keywords: Exercise capacity
Pulmonary function
Quality of life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with control group
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Six-Minute Walk Test (6MWT)
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Pulmonary Function Tests (PFT)
timeFrame: Change from Baseline at 8 weeks
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Change from Baseline at 8 weeks
measure: Nitric Oxide Levels
timeFrame: Change from Baseline at 8 weeks
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: New York Heart Association (NYHA) Classification
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa (IUC) Cardiology Institute
Study officials:
affiliation: Istanbul University-Cerrahpasa (IUC) Cardiology Institute
name: Rengin Demir, Prof
role: STUDY_DIRECTOR
affiliation: Istanbul University-Cerrahpasa (IUC) Cardiology Institute
name: Veysel Oktay, Assoc Prof
role: STUDY_CHAIR
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