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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Inspiratory Muscle Training
  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
• Другое Baduanjin Exercise
  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.

Первичные конечные точки

• The Six-Minute Walk Test (6MWT) [Срок оценки: Change from Baseline at 8 weeks]

Вторичные конечные точки (5)

• Pulmonary Function Tests (PFT) [Срок оценки: Change from Baseline at 8 weeks]
• Maximal Inspiratory Pressure (MIP) [Срок оценки: Change from Baseline at 8 weeks]
• Nitric Oxide Levels [Срок оценки: Change from Baseline at 8 weeks]
• Minnesota Living with Heart Failure Questionnaire [Срок оценки: Change from Baseline at 8 weeks]
• New York Heart Association (NYHA) Classification [Срок оценки: Change from Baseline at 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University-Cerrahpasa (IUC) Cardiology Institute — Istanbul

Публикации

• 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. PMID 29655825
• Marian 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. PMID 28912181
• Maron 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. PMID 24998133
• Maron 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. PMID 30110588
• Ommen 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 PMID 33229115
• Maron BJ. Hypertrophic cardiomyopathy: a systematic review. JAMA. 2002 Mar 13;287(10):1308-20. doi: 10.1001/jama.287.10.1308. PMID 11886323
• Sharma 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. PMID 10913477
• Christiaans 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. PMID 19253387

Идентификаторы

NCT: NCT06490250 · IUC-FTR-MY-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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