Respiratory Muscles Training in Patients With Dilated Cardiomyopathy

Brief Title

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

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.

      .
    

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.
    

Study Type

Interventional

Primary Outcome

Ejection fraction

Secondary Outcome

 Memorial symptom assessment scale - Heart failure

Condition

Dilated Cardiomyopathy

Intervention

Treadmill training

Study Arms / Comparison Groups

 Treadmill training group

Description:  Treadmill training according to American College of Sports Medicine's guidelines

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

22

Start Date

August 15, 2019

Completion Date

January 30, 2020

Primary Completion Date

January 20, 2020

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.
      

Gender

All

Ages

30 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Suman Sheraz, PhD*, , 

Location Countries

Pakistan

Location Countries

Pakistan

NCT ID

NCT04307823

Organization ID

REC/00596 Hanifa Suleman

Responsible Party

Sponsor

Study Sponsor

Riphah International University

Study Sponsor

Suman Sheraz, PhD*, Principal Investigator, Riphah International University

Verification Date

March 2020