Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06490250

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

Led by Istanbul University - Cerrahpasa · Updated on 2025-06-15

51

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the effects of inspiratory muscle training and Baduanjin exercises on lung function, exercise ability, and quality of life in patients with hypertrophic cardiomyopathy (HCM), a genetic heart disease marked by thickened heart walls that can cause symptoms like shortness of breath, chest pain, and fatigue. The study aims to introduce new treatments that could improve these symptoms, exercise tolerance, and overall well-being, addressing a gap in research on exercise for HCM patients. The study includes three groups: one using an inspiratory muscle training device twice daily for 15 minutes over 8 weeks with weekly supervision; another doing Baduanjin exercises three times a week for 50 minutes, combining warm-up, eight movements, and cool-down; and a control group receiving no intervention. Each group will have 17 participants, and the interventions are designed to assess their comparative impact on lung and heart health. Participants will undergo assessments including the Six-Minute Walk Test to measure exercise capacity, lung function tests, inspiratory muscle strength, nitric oxide levels, and quality of life questionnaires over the 8-week period. Researchers will monitor changes to evaluate how these exercises affect heart failure symptoms and daily living. The study will run until November 2025, helping to understand potential benefits of these exercise methods in HCM care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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/m�b2)
  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants engage in either inspiratory muscle training or Baduanjin exercises to improve pulmonary function, exercise capacity, and quality of life. The inspiratory muscle training involves daily 15-minute sessions with weekly supervision. The Baduanjin exercise involves a 50-minute session three times a week, including in-person and online sessions. Control group participants do not receive any intervention.

Weekly visits for supervision and exercise sessions

Trial Site Locations

Total: 1 location

1

Istanbul University-Cerrahpasa (IUC) Cardiology Institute

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

R

Rengin Demir, Prof

V

Veysel Oktay, Assoc Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Hypertrophic cardiomyopathy: present and future, with translation into contemporary cardiovascular medicine.

Barry J Maron, Steve R Ommen, Christopher Semsarian...

https://pubmed.ncbi.nlm.nih.gov/24998133

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.

Steve R Ommen, Seema Mital, Michael A Burke...

https://pubmed.ncbi.nlm.nih.gov/33229115

Utility of cardiopulmonary exercise in the assessment of clinical determinants of functional capacity in hypertrophic cardiomyopathy.

S Sharma, P Elliott, G Whyte...

https://pubmed.ncbi.nlm.nih.gov/10913477

Quality of life and psychological distress in hypertrophic cardiomyopathy mutation carriers: a cross-sectional cohort study.

Imke Christiaans, Irene M van Langen, Erwin Birnie...

https://pubmed.ncbi.nlm.nih.gov/19253387