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

NCT06490250 | Recruiting

• 1 other identifier: IUC-FTR-MY-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy; Heart Diseases

Keywords

Exercise capacity; Pulmonary function; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at 8 weeks

Secondary Outcomes (5)

• Pulmonary Function Tests (PFT)

  Change from Baseline at 8 weeks

• Maximal Inspiratory Pressure (MIP)

  Change from Baseline at 8 weeks

• Nitric Oxide Levels

  Change from Baseline at 8 weeks

• Minnesota Living with Heart Failure Questionnaire

  Change from Baseline at 8 weeks

• New York Heart Association (NYHA) Classification

  Change from Baseline at 8 weeks

Study Arms (3)

Inspiratory Muscle Training (IMT) Group

EXPERIMENTAL

The inspiratory muscle training group will participate in the respiratory exercise program with the IMT device.

Other: Inspiratory Muscle Training

Baduanjin Exercise Group

EXPERIMENTAL

The Baduanjin group will participate in the Baduanjin exercise program, which includes 8 movements.

Other: Baduanjin Exercise

Control Group

NO INTERVENTION

The control group will not receive any intervention.

Interventions

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

Inspiratory Muscle Training (IMT) Group

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.

Baduanjin Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa (IUC) Cardiology Institute

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (26)

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  PMID: 29655825 BACKGROUND

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• Maron BJ. Hypertrophic cardiomyopathy: a systematic review. JAMA. 2002 Mar 13;287(10):1308-20. doi: 10.1001/jama.287.10.1308.

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• Figueiredo 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.

  PMID: 32209709 BACKGROUND

• Zeren 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.

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  PMID: 32936904 BACKGROUND

• Hossein 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.

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• Chan JS, Li A, Ng SM, Ho RT, Xu A, Yao TJ, Wang XM, So KF, Chan CL. Adiponectin Potentially Contributes to the Antidepressive Effects of Baduanjin Qigong Exercise in Women With Chronic Fatigue Syndrome-Like Illness. Cell Transplant. 2017 Mar 13;26(3):493-501. doi: 10.3727/096368916X694238. Epub 2016 Dec 7.

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MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiomyopathies; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Rengin Demir, Prof

  Istanbul University-Cerrahpasa (IUC) Cardiology Institute

  STUDY DIRECTOR

• Veysel Oktay, Assoc Prof

  Istanbul University-Cerrahpasa (IUC) Cardiology Institute

  STUDY CHAIR

Central Study Contacts

Rengin Demir, Prof

CONTACT

+902124592000; rengindemir@yahoo.com

Veysel Oktay, Assoc Prof

CONTACT

+902124592000; drvoktay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an investigator who is blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: Three groups with control group

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: October 25, 2024
• Primary Completion: July 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)