Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design
Hypertrophic cardiomyopathy (HCM) is the most common congenital disease increasing the risk of sudden cardiac death. For many years, HCM patients were excluded from exercise training. However, there are data showing that patients with HCM undergoing supervised exercise training could improve physica...
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MDPI AG
2022-05-01
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| Series: | Applied Sciences |
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| Online Access: | https://www.mdpi.com/2076-3417/12/10/5046 |
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| author | Krzysztof Sadowski Ryszard Piotrowicz Mariusz Kłopotowski Jadwiga Wolszakiewicz Agnieszka Lech Adam Witkowski Edyta Smolis-Bąk Ilona Kowalik Anna Mierzyńska Dorota Piotrowska Piotr Dobrowolski Maciej Dąbrowski Ewa Sadowy Ewa Piotrowicz |
| author_facet | Krzysztof Sadowski Ryszard Piotrowicz Mariusz Kłopotowski Jadwiga Wolszakiewicz Agnieszka Lech Adam Witkowski Edyta Smolis-Bąk Ilona Kowalik Anna Mierzyńska Dorota Piotrowska Piotr Dobrowolski Maciej Dąbrowski Ewa Sadowy Ewa Piotrowicz |
| author_sort | Krzysztof Sadowski |
| collection | DOAJ |
| description | Hypertrophic cardiomyopathy (HCM) is the most common congenital disease increasing the risk of sudden cardiac death. For many years, HCM patients were excluded from exercise training. However, there are data showing that patients with HCM undergoing supervised exercise training could improve physical performance without serious adverse events. A project was designed as a randomized clinical trial to assess the effectiveness and safety of hybrid cardiac rehabilitation (HCR)—a combination of hospital-based cardiac rehabilitation (1 month) with a new form of home-based telemonitored cardiac rehabilitation (2 months) in HCM patients without left ventricular (LV) outflow tract obstruction and preserved systolic function. Sixty patients who fulfil the inclusion criteria have been randomly assigned (1:1) to either HCR plus usual care (training group) or usual care only (control group). The primary endpoint is a functional capacity evaluated by peak oxygen uptake (pVO<sub>2</sub>). Secondary endpoints include workload time during the cardiopulmonary exercise testing, a six-minute walk test distance, NT-pro BNP level, echocardiographic parameters of the left ventricular diastolic function (E/A, E/e’, myocardial strain rate), right ventricular systolic pressure, a gradient in the LV outflow tract, and quality of life. The tertiary analysis includes safety, acceptance and adherence to the HCR program. Our research will provide innovative data on the effectiveness and safety of hybrid cardiac rehabilitation in HCM patients without LV outflow tract obstruction and preserved systolic function. Clinical trials registry: ClinicalTrials.gov Identifier NCT03178357. |
| first_indexed | 2024-03-10T03:23:56Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 2076-3417 |
| language | English |
| last_indexed | 2024-03-10T03:23:56Z |
| publishDate | 2022-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Applied Sciences |
| spelling | doaj.art-f4acb249a00e463094755aee7f7441742023-11-23T09:57:02ZengMDPI AGApplied Sciences2076-34172022-05-011210504610.3390/app12105046Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study DesignKrzysztof Sadowski0Ryszard Piotrowicz1Mariusz Kłopotowski2Jadwiga Wolszakiewicz3Agnieszka Lech4Adam Witkowski5Edyta Smolis-Bąk6Ilona Kowalik7Anna Mierzyńska8Dorota Piotrowska9Piotr Dobrowolski10Maciej Dąbrowski11Ewa Sadowy12Ewa Piotrowicz13Department of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Interventional Cardiology and Angiology, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Congenital Heart Diseases, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Interventional Cardiology and Angiology, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Hypertension, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Interventional Cardiology and Angiology, National Institute of Cardiology, 04-628 Warsaw, PolandDepartment of Coronary Artery Disease and Cardiac Rehabilitation, National Institute of Cardiology, 04-628 Warsaw, PolandTelecardiology Center, National Institute of Cardiology, 04-628 Warsaw, PolandHypertrophic cardiomyopathy (HCM) is the most common congenital disease increasing the risk of sudden cardiac death. For many years, HCM patients were excluded from exercise training. However, there are data showing that patients with HCM undergoing supervised exercise training could improve physical performance without serious adverse events. A project was designed as a randomized clinical trial to assess the effectiveness and safety of hybrid cardiac rehabilitation (HCR)—a combination of hospital-based cardiac rehabilitation (1 month) with a new form of home-based telemonitored cardiac rehabilitation (2 months) in HCM patients without left ventricular (LV) outflow tract obstruction and preserved systolic function. Sixty patients who fulfil the inclusion criteria have been randomly assigned (1:1) to either HCR plus usual care (training group) or usual care only (control group). The primary endpoint is a functional capacity evaluated by peak oxygen uptake (pVO<sub>2</sub>). Secondary endpoints include workload time during the cardiopulmonary exercise testing, a six-minute walk test distance, NT-pro BNP level, echocardiographic parameters of the left ventricular diastolic function (E/A, E/e’, myocardial strain rate), right ventricular systolic pressure, a gradient in the LV outflow tract, and quality of life. The tertiary analysis includes safety, acceptance and adherence to the HCR program. Our research will provide innovative data on the effectiveness and safety of hybrid cardiac rehabilitation in HCM patients without LV outflow tract obstruction and preserved systolic function. Clinical trials registry: ClinicalTrials.gov Identifier NCT03178357.https://www.mdpi.com/2076-3417/12/10/5046hypertrophic cardiomyopathyexercise trainingrehabilitationtelerehabilitation |
| spellingShingle | Krzysztof Sadowski Ryszard Piotrowicz Mariusz Kłopotowski Jadwiga Wolszakiewicz Agnieszka Lech Adam Witkowski Edyta Smolis-Bąk Ilona Kowalik Anna Mierzyńska Dorota Piotrowska Piotr Dobrowolski Maciej Dąbrowski Ewa Sadowy Ewa Piotrowicz Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design Applied Sciences hypertrophic cardiomyopathy exercise training rehabilitation telerehabilitation |
| title | Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design |
| title_full | Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design |
| title_fullStr | Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design |
| title_full_unstemmed | Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design |
| title_short | Efficacy and Safety of Hybrid Cardiac Telerehabilitation in Patients with Hypertrophic Cardiomyopathy without Left Ventricular Outflow Tract Obstruction and Preserved Ejection Fraction—A Study Design |
| title_sort | efficacy and safety of hybrid cardiac telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction and preserved ejection fraction a study design |
| topic | hypertrophic cardiomyopathy exercise training rehabilitation telerehabilitation |
| url | https://www.mdpi.com/2076-3417/12/10/5046 |
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