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

NCT04905433 | Completed

• 1 other identifier: IMT and CR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

chronic heart failure; inspiratory muscle training; cardiac rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• forced vital capacity

  12 weeks

• rate of perceived exertion

  12 weeks

Study Arms (2)

Cardiac rehabilitation with breathing retraining

EXPERIMENTAL

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

cardiac rehabilitation

ACTIVE COMPARATOR

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

Interventions

Cardiac rehabilitation with breathing retraining BEHAVIORAL

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)

Cardiac rehabilitation with breathing retraining

Cardiac rehabilitation BEHAVIORAL

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

cardiac rehabilitation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• National Heart Institute, Egypt: collaborator

Study Sites (1)

National heart institute

Cairo, AI Qahirah, 11847, Egypt

Location

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hady Atef, PhD

  Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

• Donna Fitzimons, Prof

  Queen's University, Belfast

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 27, 2021
• Study Start: June 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after 1 month for12 months
• Access Criteria: will upload it to the journal of publication

Locations

EG (1)