Respiratory Muscles Training in Patients With Dilated Cardiomyopathy

NCT04307823 | Completed

• 1 other identifier: REC/00596 Hanifa Suleman
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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. .

Conditions

Dilated Cardiomyopathy

Keywords

Bruce protocol; Congestive heart failure; Dilated cardiomyopathy; Incentive spirometry; Slow breathing training

Outcome Measures

Primary Outcomes (3)

• Ejection fraction

  Ejection fraction calculated through echocardiography

  After 4 weeks of intervention

• LV End systolic dimension

  LV End systolic dimension calculated through echocardiography

  After 4 weeks of intervention

• LV End diastolic dimension

  LV End diastolic dimension calculated through echocardiography

  After 4 weeks of intervention

Secondary Outcomes (5)

• Memorial symptom assessment scale - Heart failure

  After 4 weeks of intervention

• Forced Expiratory volume 1(FEV1)

  After 4 weeks of intervention

• Forced Vital capacity(FVC)

  After 4 weeks of intervention

• FEV1/FVC

  After 4 weeks of intervention

• Peak Expiratory Flow Rate (PEFR)

  After 4 weeks of intervention

Study Arms (2)

Treadmill training group

ACTIVE COMPARATOR

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

Other: Treadmill training

Treadmill protocol and respiratory training group

EXPERIMENTAL

Treadmill training, slow breathing training and incentive spirometry

Other: Treadmill protocol and Respiratory training

Interventions

Treadmill training OTHER

3 days per week, starting at shorter duration 5-20min and progressed to 30- 40mins. Training% or Intensity was kept 40-70%, Training Heart Rate (HR) was calculated through formula: HR max HR rest\*Ex intensity + HR rest Rate of Perceived Exertion (RPE) 9-14 ON 6 -20 RPE scale The session was terminated if sustained ventricular arrhythmia, symptomatic drop in blood pressure, ST elevation, or development of severe symptoms

Treadmill training group

Treadmill protocol and Respiratory training OTHER

Treadmill protocol Spirometry: Volumetric exercises, using incentive Spirometer 10-15 repetitions Slow breathing training: 5 minutes: spontaneous breathing, 4 minutes: controlled breathing (15 breaths/min) 4 minutes of controlled breathing (6 breaths/min) Treatment provided for 3 days in a week for a period of 4 weeks

Treadmill protocol and respiratory training group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (8)

• 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.

  PMID: 26935038 BACKGROUND

• 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.

  PMID: 29209423 BACKGROUND

• 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.

  PMID: 26513698 BACKGROUND

• 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.

  PMID: 31235420 BACKGROUND

• 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.

  PMID: 31345646 BACKGROUND

• 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.

  PMID: 30697682 BACKGROUND

• 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.

  PMID: 27182763 BACKGROUND

• 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.

  PMID: 31399956 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Suman Sheraz, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 13, 2020
• Study Start: August 15, 2019
• Primary Completion: January 20, 2020
• Study Completion: January 30, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)