Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients
NCT Number: NCT06490250
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertrophic Cardiomyopathy|Heart Diseases
Interventions: OTHER: Inspiratory Muscle Training|OTHER: Baduanjin Exercise
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2025-11-30
Locations: Istanbul University-Cerrahpasa (IUC) Cardiology Institute, Istanbul, Turkey

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.

Primary Outcome Measures: 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 Outcome Measures: Pulmonary Function Tests (PFT), Pulmonary function tests will be conducted using a spirometer, following the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria., Change from Baseline at 8 weeks|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., Change from Baseline at 8 weeks|Nitric Oxide Levels, Nitric oxide levels' measurements will be performed with a fractional exhaled nitric oxide (FeNO) device., Change from Baseline at 8 weeks|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., Change from Baseline at 8 weeks|New York Heart Association (NYHA) Classification, The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain., Change from Baseline at 8 weeks