Respiratory Muscles Training in Patients With Dilated Cardiomyopathy
Primary Purpose
Dilated Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Treadmill training
Treadmill protocol and Respiratory training
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Bruce protocol, Congestive heart failure, Dilated cardiomyopathy, Incentive spirometry, Slow breathing training
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.
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treadmill training group
Treadmill protocol and respiratory training group
Arm Description
Treadmill training according to American College of Sports Medicine's guidelines
Treadmill training, slow breathing training and incentive spirometry
Outcomes
Primary Outcome Measures
Ejection fraction
Ejection fraction calculated through echocardiography
LV End systolic dimension
LV End systolic dimension calculated through echocardiography
LV End diastolic dimension
LV End diastolic dimension calculated through echocardiography
Secondary Outcome Measures
Memorial symptom assessment scale - Heart failure
Memorial symptom assessment scale for heart failure patients (MSAS-HF) is a patient-rated instrument to assess the quality of life of heart failure patients. It scores 32 symptoms including 26 physical symptoms of distress and 6 psychological symptoms are recorded.
Distress is rated on a 5 point scale each symptom is scored from 0 to 4 ranging from "no symptom" to "very much." If the symptom is not present, a value of zero is assigned.
Frequency of psychological symptoms is scored as 1-rarely, 2- occasionally, 3-frequently, and 4- almost constantly.
The symptom scores are combined into various sub-scales scores including the psychological sub-scale score, physical sub-scale, global distress index and total MSAS score. The mean score in each category is calculated with higher scores indicating poor quality of life.
Forced Expiratory volume 1(FEV1)
Forced Expiratory volume 1(FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Forced Vital capacity(FVC)
Forced Vital capacity(FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
FEV1/FVC
FEV1/FVC measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Peak Expiratory Flow Rate (PEFR)
Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Full Information
NCT ID
NCT04307823
First Posted
March 2, 2020
Last Updated
March 12, 2020
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04307823
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
Bruce protocol, Congestive heart failure, Dilated cardiomyopathy, Incentive spirometry, Slow breathing training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadmill training group
Arm Type
Active Comparator
Arm Description
Treadmill training according to American College of Sports Medicine's guidelines
Arm Title
Treadmill protocol and respiratory training group
Arm Type
Experimental
Arm Description
Treadmill training, slow breathing training and incentive spirometry
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Treadmill protocol and Respiratory training
Intervention Description
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
Primary Outcome Measure Information:
Title
Ejection fraction
Description
Ejection fraction calculated through echocardiography
Time Frame
After 4 weeks of intervention
Title
LV End systolic dimension
Description
LV End systolic dimension calculated through echocardiography
Time Frame
After 4 weeks of intervention
Title
LV End diastolic dimension
Description
LV End diastolic dimension calculated through echocardiography
Time Frame
After 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Memorial symptom assessment scale - Heart failure
Description
Memorial symptom assessment scale for heart failure patients (MSAS-HF) is a patient-rated instrument to assess the quality of life of heart failure patients. It scores 32 symptoms including 26 physical symptoms of distress and 6 psychological symptoms are recorded.
Distress is rated on a 5 point scale each symptom is scored from 0 to 4 ranging from "no symptom" to "very much." If the symptom is not present, a value of zero is assigned.
Frequency of psychological symptoms is scored as 1-rarely, 2- occasionally, 3-frequently, and 4- almost constantly.
The symptom scores are combined into various sub-scales scores including the psychological sub-scale score, physical sub-scale, global distress index and total MSAS score. The mean score in each category is calculated with higher scores indicating poor quality of life.
Time Frame
After 4 weeks of intervention
Title
Forced Expiratory volume 1(FEV1)
Description
Forced Expiratory volume 1(FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Time Frame
After 4 weeks of intervention
Title
Forced Vital capacity(FVC)
Description
Forced Vital capacity(FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Time Frame
After 4 weeks of intervention
Title
FEV1/FVC
Description
FEV1/FVC measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Time Frame
After 4 weeks of intervention
Title
Peak Expiratory Flow Rate (PEFR)
Description
Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Time Frame
After 4 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26935038
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.
Results Reference
background
PubMed Identifier
29209423
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.
Results Reference
background
PubMed Identifier
26513698
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.
Results Reference
background
PubMed Identifier
31235420
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.
Results Reference
background
PubMed Identifier
31345646
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.
Results Reference
background
PubMed Identifier
30697682
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.
Results Reference
background
PubMed Identifier
27182763
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.
Results Reference
background
PubMed Identifier
31399956
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.
Results Reference
background
Learn more about this trial
Respiratory Muscles Training in Patients With Dilated Cardiomyopathy
We'll reach out to this number within 24 hrs