Clinical trial NCT04307823: Respiratory Muscles Training in Patients With Dilated Cardiomyopathy
Official title: Effects of Respiratory Muscles Training on Cardiopulmonary Parameters and Quality of Life in Patients With Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dilated Cardiomyopathy
Keywords: Bruce protocol
Congestive heart failure
Dilated cardiomyopathy
Incentive spirometry
Slow breathing training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effects of respiratory muscles training on cardiopulmonary parameters and quality of life in patients with dilated cardiomyopathy (DCM). It was a randomized control trial conducted on the calculated sample size of 22 patients divided into 2 groups. Study was conducted at Shifa International Hospital Islamabad. Clinically stable, diagnosed cases of DCM aged 30 to 60 years were included in the study. Outcomes of study were ejection fraction, Left ventricular (LV) End systolic dimensions, LV End diastolic dimension, lung volumes and capacities and quality of life. Data was analyzed on Statistical Package for the Social Sciences (SPSS) version 21.

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Detailed description: Dilated cardiomyopathy is the most common type of heart failure and primary source of heart replacement globally. It is characterized by poor left ventricular function,enlargement of left ventricle and systolic dysfunction. The underlying cause of DCM in adults is usually coronary artery disease, but other causes include inflammatory heart disease, myocardial toxins, and genetic defects; approximately 30% to 35% of patients are reported to have a genetic form of dilated cardiomyopathy. Most common sign and symptoms of dilated cardiomyopathy are ankle swelling, dyspnea, fatigue, elevated jugular venous pressure elevated, pulmonary rales due to reduced cardiac function with low output and elevated intra cardiac pressures. Other sign and symptoms chest pain due to reduced coronary blood flow, palpitation, syncope and sudden cardiac death. There is reduced exercise tolerance with fatigue and dyspnea, contributing to poor prognosis and quality of life.

Chronic heart failure (CHF) patients have limited capacity to exercise and have impairments in breathing function.Respiratory muscle weakness is a part of the underlying cause for exercise intolerance in patients with heart failure with reduced ejection fraction.

Pharmacological and non pharmacological management is directed to reduce clinical sign and symptoms and control of disease progression and complications like sudden cardiac arrest. Physical rehabilitation is beneficial, effective and safe for functional limitation of DCM patients. A modified Bruce protocol is usually used to gradually increase exercise intensity in cardiac rehabilitation programs for patients with cardiomyopathy. Bruce protocol was used to observe fluctuations in heart rate through a quick increase of exercise intensity for a short period of time. Some patients are able to exercise with higher intensity safely, but many patients reported difficulties on treadmill exercise. This becomes even more difficult when the intensity of the treadmill exercise is increased.

Various studies have demonstrated the effects of exercise as well as inspiratory muscle training for improvement in patients with CHF and have considered it an important component of cardiac rehabilitation. Respiratory muscles training is commonly performed using inspiratory resistance devices but studies have proven that incentive spirometry could be an interesting alternative for clinical use for the cases where there is difficult to acquire the devices. Slow breathing treatment is safe and induces favourable effects in cardiopulmonary parameters, decreases rate of dyspnea, improves exercise performance and increases respiratory muscles and function. Deeper and slow breathing involves the use of diaphragm that is activated during slow breathing and does not increase respiratory workload.Respiratory muscles training is safe and improves physiologic parameters including an increase in oxygen saturation and improved exercise capacity, leading to an improvement in health status.

This study is intended to observed the overall effect of respiratory muscles training including slow breathing and incentive spirometry along with treadmill training according to bruce protocol for improvement in their ejection fraction, left ventricular dimensions , pulmonary function and quality of life.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of DCM
* New York Heart Association class (II)
* Clinically stable patients for at least (3) months
* Ejection Fraction (25 - 40%)

Exclusion Criteria:

* Recent myocardial infarction, exercise induced angina and Syncope,
* Atrioventricular valve disease, selected for heart transplant
* Uncontrolled hypertension.
* Uncontrolled diabetes.
* Significant pulmonary disease. Intellectual, neurological or musculoskeletal abnormalities.

Primary outcomes:
measure: Ejection fraction
timeFrame: After 4 weeks of intervention
measure: LV End systolic dimension
timeFrame: After 4 weeks of intervention
measure: LV End diastolic dimension
timeFrame: After 4 weeks of intervention
Secondary outcomes:
measure: Memorial symptom assessment scale - Heart failure
timeFrame: After 4 weeks of intervention
measure: Forced Expiratory volume 1(FEV1)
timeFrame: After 4 weeks of intervention
measure: Forced Vital capacity(FVC)
timeFrame: After 4 weeks of intervention
measure: FEV1/FVC
timeFrame: After 4 weeks of intervention
measure: Peak Expiratory Flow Rate (PEFR)
timeFrame: After 4 weeks of intervention
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziaeian B, Fonarow GC. Epidemiology and aetiology of heart failure. Nat Rev Cardiol. 2016 Jun;13(6):368-78. doi: 10.1038/nrcardio.2016.25. Epub 2016 Mar 3.
citation: Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.
citation: Drozdz T, Bilo G, Debicka-Dabrowska D, Klocek M, Malfatto G, Kielbasa G, Styczkiewicz K, Bednarek A, Czarnecka D, Parati G, Kawecka-Jaszcz K. Blood pressure changes in patients with chronic heart failure undergoing slow breathing training. Blood Press. 2016;25(1):4-10. doi: 10.3109/08037051.2016.1099800. Epub 2015 Oct 29.
citation: Wasserstrum Y, Barbarova I, Lotan D, Kuperstein R, Shechter M, Freimark D, Segal G, Klempfner R, Arad M. Efficacy and safety of exercise rehabilitation in patients with hypertrophic cardiomyopathy. J Cardiol. 2019 Nov;74(5):466-472. doi: 10.1016/j.jjcc.2019.04.013. Epub 2019 Jun 22.
citation: Gomes-Neto M, Duraes AR, Conceicao LSR, Roever L, Silva CM, Alves IGN, Ellingsen O, Carvalho VO. Effect of combined aerobic and resistance training on peak oxygen consumption, muscle strength and health-related quality of life in patients with heart failure with reduced left ventricular ejection fraction: a systematic review and meta-analysis. Int J Cardiol. 2019 Oct 15;293:165-175. doi: 10.1016/j.ijcard.2019.02.050. Epub 2019 Jun 24.
citation: Lachowska K, Bellwon J, Morys J, Gruchala M, Hering D. Slow breathing improves cardiovascular reactivity to mental stress and health-related quality of life in heart failure patients with reduced ejection fraction. Cardiol J. 2020;27(6):772-779. doi: 10.5603/CJ.a2019.0002. Epub 2019 Jan 30.
citation: Neto MG, Martinez BP, Conceicao CS, Silva PE, Carvalho VO. Combined Exercise and Inspiratory Muscle Training in Patients With Heart Failure: A SYSTEMATIC REVIEW AND META-ANALYSIS. J Cardiopulm Rehabil Prev. 2016 Nov/Dec;36(6):395-401. doi: 10.1097/HCR.0000000000000184.
citation: Leggio M, Fusco A, Loreti C, Limongelli G, Bendini MG, Mazza A, Coraci D, Padua L. Effects of exercise training in heart failure with preserved ejection fraction: an updated systematic literature review. Heart Fail Rev. 2020 Sep;25(5):703-711. doi: 10.1007/s10741-019-09841-x.