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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Behavioral: Cardiac rehabilitation with breathing retraining; Behavioral: Cardiac rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • AI Qahirah
    • Cairo, AI Qahirah, Egypt, 11847
      • National Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac rehabilitation with breathing retraining; 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)	Behavioral: Cardiac rehabilitation with breathing retraining; 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)
Active Comparator: cardiac rehabilitation; 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	Behavioral: Cardiac rehabilitation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability	represent autonomic response of the heart (measured through a holter ECG)	12 weeks
functional capacity	represents aerobic fitness (VO2 max) (ml/kg/min) measured through cardiopulmonary exercise testing	12 weeks
anaerobic threshold	represents lactate threshold (% of VO2 max) measured through cardiopulmonary exercise testing	12 weeks
resting heart rate	represents resting condition of the heart (beat/min)	12 weeks
resting systolic blood pressure	represents resting condition of the systolic blood pressure (mmhg) measured by sphygmomanometer	12 weeks
resting diastolic blood pressure	represents resting condition of the diastolic blood pressure (mmhg) measured by sphygmomanometer	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
forced vital capacity	represents volume of air in a forced expiration after full inspiration (%) measured by pulmonary function testing	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: National Heart Institute, Egypt
• Investigators: Principal Investigator: Hady Atef, PhD, Cairo university, Egypt; Study Director: Donna Fitzimons, Prof, Queen's University Belfast, UK

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: inspiratory muscle training; chronic heart failure; cardiac rehabilitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IMT and CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No