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The Need for Breathing Retraining: the Elephant in the Cardiac Rehabilitation Room

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cardiac rehabilitation with breathing retraining
Cardiac rehabilitation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, inspiratory muscle training, cardiac rehabilitation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • . chronic heart failure (≥ 1 year) .Respiratory muscle weakness≤ 70% of their predicted MIP.

    • Ages ranged from 45-65 years old
    • Left ventricle ejection fraction ≤ 40% in NYHA class II and III .In stable condition (No rales on auscultation or tibial edema and with sinus rhythm).
    • On standard cardiac medications (diuretics, angiotensin-converting enzyme (ACE) inhibitors, and glycosides)
    • Not engaged in any regular physical training program for at least one month before the start of the study.

Exclusion Criteria:

  • Chronic lung disorders,

    • Anemia
    • Severe hypoxia
    • History of myocardial infarction or pulmonary edema six months before the study
    • Severe uncontrolled hypertension, or uncontrolled diabetes mellitus or autonomic disorders

Sites / Locations

  • National heart institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiac rehabilitation with breathing retraining

cardiac rehabilitation

Arm Description

A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling), with a breathing retraining (using breathing calisthenics, and inspiratory muscle training)

A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling) only

Outcomes

Primary Outcome Measures

heart rate variability
represent autonomic response of the heart (measured through a holter ECG)
functional capacity
represents aerobic fitness (VO2 max) (ml/kg/min) measured through cardiopulmonary exercise testing
anaerobic threshold
represents lactate threshold (% of VO2 max) measured through cardiopulmonary exercise testing
resting heart rate
represents resting condition of the heart (beat/min)
resting systolic blood pressure
represents resting condition of the systolic blood pressure (mmhg) measured by sphygmomanometer
resting diastolic blood pressure
represents resting condition of the diastolic blood pressure (mmhg) measured by sphygmomanometer

Secondary Outcome Measures

forced vital capacity
represents volume of air in a forced expiration after full inspiration (%) measured by pulmonary function testing
rate of perceived exertion
represents level of patient exertion on exercise measured by modified Borg scale (1-10), where lower scores means lower levels of exertion, and higher scores means higher levels of exertion.

Full Information

First Posted
May 19, 2021
Last Updated
January 10, 2022
Sponsor
Cairo University
Collaborators
National Heart Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04905433
Brief Title
The Need for Breathing Retraining: the Elephant in the Cardiac Rehabilitation Room
Official Title
The Need for Breathing Retraining: the Elephant in the Cardiac Rehabilitation Room
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
National Heart Institute, Egypt

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
As an extension of previous work, in this study, a breathing retraining component is added using breathing calisthenics and inspiratory muscle trainer for the classical cardiac rehabilitation (CR), as an appealing option, to implement a comprehensive rehabilitation protocol addressing the different patient-centered outcomes including different cardiovascular, and respiratory complaints; increasing the benefits of classical CR; detecting the impact of adding this on the cardiovascular (CV) outcomes, and discovering the correlation between the CV and respiratory data.
Detailed Description
A very large number of studies have demonstrated the positive effect of cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) on morbidity and mortality. Globally, each year millions of patients with different cardiovascular diseases (CVD) and chest diseases are enrolled in these programs. The exact effects may be slightly variable, but generally, both CR and PR aim to improve the patient's condition and improve the overall quality of life utilizing almost the same methods (exercise, and education). Despite these positive effects, utilization rates of either CR or PR are around 30% in Europe, with much less percentages in the Middle East. The reasons for the low engagement rates are many; with most probably the main reasons are about individuality and reach. Optimized CR programs have to be individually tailored; meeting the individual needs of every single patient in the program. Worse knowing that the chest pain and breathlessness are highly prevalent in general in CVD, and considered -in many cases as the chief complaint, and the classical CR programs are neglecting these complaints; negatively affecting adherence rates and patient-centered outcomes (PCO) which mostly extend much beyond the cardiovascular complaints, to extend to the respiratory, and sleep complaints; questioning the reason why breathing retraining methods are not yet considered as an integral part of the CR programs. The reason that standard CR programs usually neglect these complaints, and only look for the CV outcomes; is considering the other mentioned complaints as "out-of-context". However, solid evidence is suggesting a strong correlation between respiratory, sleep, and CV outcomes. It has been previously investigated the impact of the CR on sleep, and there is a prior estimate suggesting that 25% of the participants in the CR programs have already sleep disorders, there is a strong correlation between the sleep and CV outcomes, and almost all of the patients in the CR have respiratory symptoms including dyspnea and functional capacity decline. Therefore, it was suggested adding a breathing retraining component using breathing calisthenics and inspiratory muscle trainer for the classical CR, as an appealing option, to implement a comprehensive rehabilitation protocol addressing the different PCO including different cardiovascular, and respiratory complaints; increasing the benefits of classical CR; detecting the impact of adding this on the CV outcomes, and discovering the correlation between the CV and respiratory data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, inspiratory muscle training, cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac rehabilitation with breathing retraining
Arm Type
Experimental
Arm Description
A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling), with a breathing retraining (using breathing calisthenics, and inspiratory muscle training)
Arm Title
cardiac rehabilitation
Arm Type
Active Comparator
Arm Description
A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling) only
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation with breathing retraining
Intervention Description
A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling), with a breathing retraining (using breathing calisthenics, and inspiratory muscle training)
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling) only
Primary Outcome Measure Information:
Title
heart rate variability
Description
represent autonomic response of the heart (measured through a holter ECG)
Time Frame
12 weeks
Title
functional capacity
Description
represents aerobic fitness (VO2 max) (ml/kg/min) measured through cardiopulmonary exercise testing
Time Frame
12 weeks
Title
anaerobic threshold
Description
represents lactate threshold (% of VO2 max) measured through cardiopulmonary exercise testing
Time Frame
12 weeks
Title
resting heart rate
Description
represents resting condition of the heart (beat/min)
Time Frame
12 weeks
Title
resting systolic blood pressure
Description
represents resting condition of the systolic blood pressure (mmhg) measured by sphygmomanometer
Time Frame
12 weeks
Title
resting diastolic blood pressure
Description
represents resting condition of the diastolic blood pressure (mmhg) measured by sphygmomanometer
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
forced vital capacity
Description
represents volume of air in a forced expiration after full inspiration (%) measured by pulmonary function testing
Time Frame
12 weeks
Title
rate of perceived exertion
Description
represents level of patient exertion on exercise measured by modified Borg scale (1-10), where lower scores means lower levels of exertion, and higher scores means higher levels of exertion.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . chronic heart failure (≥ 1 year) .Respiratory muscle weakness≤ 70% of their predicted MIP. Ages ranged from 45-65 years old Left ventricle ejection fraction ≤ 40% in NYHA class II and III .In stable condition (No rales on auscultation or tibial edema and with sinus rhythm). On standard cardiac medications (diuretics, angiotensin-converting enzyme (ACE) inhibitors, and glycosides) Not engaged in any regular physical training program for at least one month before the start of the study. Exclusion Criteria: Chronic lung disorders, Anemia Severe hypoxia History of myocardial infarction or pulmonary edema six months before the study Severe uncontrolled hypertension, or uncontrolled diabetes mellitus or autonomic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hady Atef, PhD
Organizational Affiliation
Cairo University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donna Fitzimons, Prof
Organizational Affiliation
Queen's University Belfast, UK
Official's Role
Study Director
Facility Information:
Facility Name
National heart institute
City
Cairo
State/Province
AI Qahirah
ZIP/Postal Code
11847
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After approval can be shared
IPD Sharing Time Frame
after 1 month for12 months
IPD Sharing Access Criteria
will upload it to the journal of publication

Learn more about this trial

The Need for Breathing Retraining: the Elephant in the Cardiac Rehabilitation Room

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