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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Acute decompensated heart failure

Decreased ejection fraction (<40%)

Unstable angina pectoris

Significant coronary artery disease (CAD)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory Muscle Training

    Other intervention

    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 intervention

    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.

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: Inspiratory Muscle Training (IMT) GroupExperimental treatment 1 intervention
Group B: Baduanjin Exercise GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
Change from Baseline at 8 weeks

Secondary outcomes

1

Pulmonary Function Tests (PFT)

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

Time frame
Change from Baseline at 8 weeks
2

Maximal Inspiratory Pressure (MIP)

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.

Time frame
Change from Baseline at 8 weeks
3

Nitric Oxide Levels

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

Time frame
Change from Baseline at 8 weeks
4

Minnesota Living with Heart Failure Questionnaire

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.

Time frame
Change from Baseline at 8 weeks

Other outcomes

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