The Effect of Inspiratory Muscle Training on Breathing Pattern and Functionality in Patients With Chronic Heart Failure.

The Effect of Inspiratory Muscle Training on Dysfunctional Breathing and Functional Ability in Patients With Chronic Heart Failure. A Study Protocol for a Randomized Controlled Trial

The effect of inspiratory muscle training on breathing pattern and functionality in patients with chronic heart failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Breathing Pattern Disorder
• Intervention / Treatment: Device: Inspiratory muscle training

Detailed Description

The study protocol aims to examine the impact of inspiratory muscle training on dysfunctional breathing and functional ability in patients with chronic heart failure. Inspiratory muscle training is a low-cost intervention that might improve the breathing pattern, functionality and overall quality of life in patients with chronic heart failure

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgios Mitsiou, Phd; Phone Number: 00306947888331; Email: gmitsiou@uniwa.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults aged ≥ 18 years
• diagnosis of heart failure within the previous three to twelve months
• current outpatients in a stable optimal medical regimen for at least 3 months
• able to perform inspiratory muscle training
• clinically stable, without hospital admission in the previous 3 months and without participation in any other training program in the previous 6 months

Exclusion Criteria

• unstable angina
• recent acute myocardial infarction
• uncontrolled hypertension
• valve disease
• peripheral arterial disease
• 6MWT assessment of less than 300 meters
• previous pulmonary disease (forced vital capacity <80% of predicted and/or forced expiratory volume in 1 s <70% of predicted)
• history of exercise-induced asthma
• smokers

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: Randomized controlled trial; The intervention group will be trained with inspiratory muscle training for 4 weeks. Inspiratory Muscle Training has been designed to enhance respiratory muscle function through targeted exercises, to strengthen the respiratory muscles, ,thereby improving overall respiratory efficiency	Device: Inspiratory muscle training; Participants will perform 20 sessions of respiratory muscle strengthening (20 minutes at 30-60% of MIP), using the Threshold Inspiratory Muscle Training device
No Intervention: Control group; The control group will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic Thickness	Diaphragmatic thickness measured by ultrasound is a non-invasive, widely used method to assess diaphragm structure in patients with chronic heart failure. Thickness is measured between the pleural and peritoneal lines at end-expiration and end-inspiration	From enrollment to the end of treatment at 4 weeks
Dysfunctional breathing	Dysfunctional breathing refers to abnormal breathing patterns that are often related to the heart's inability to supply blood effectively, affecting respiratory function. Dysfunctional breathing will be assessed with the Hi-Lo breathing test, an observational clinical test used to assess breathing pattern and diaphragm function. The clinician observes and palpates whether the movement is greater under the upper chest hand (Hi) or lower abdomen hand (Lo).The test is scored as "Yes" if upper chest (apical) breathing predominates and "No" if normal diaphragmatic breathing is present.	From enrollment to the end of treatment at 4 weeks
Functional ability	Functional ability refers to how well patients can perform daily activities and maintain independence despite their cardiac condition. It will be assessed with the 6-Minute Walk Test (6MWT), a simple and effective tool that evaluates the maximum distance a person can walk in six minutes. The outcome reflects the integrated response of the cardiovascular system mainly, and exercise tolerance.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal inspiratory pressure	It is a measure of the strength of inspiratory muscles, primarily the diaphragm. MIP is a reliable and reproducible measure that does not depend on the patient's respiratory flow.	From enrollment to the end of treatment at 4 weeks
Functional Dyspnea	Functional dyspnea will be measured with the Medical Research Council (MRC) Dyspnea scale, a simple grading system to evaluate the functional disability due to dyspnea. The scale ranges from 1 to 5, where 1 indicates breathlessness only with strenuous exercise and 5 indicates breathlessness that prevents leaving the house or occurs when dressing or undressing. Higher scores represent worse functional status (more severe dyspnea).	From enrollment to the end of treatment at 4 weeks
Health Related Quality of life	Quality of life will be evaluated with the Short Form Survey, a questionnaire with 12-items, that measures quality of life in terms of physical and mental health. It generates scores typically ranging from 0 to 100, with higher scores indicating better health status and quality of life.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: University of West Attica
• Investigators: Study Director: Irini Grammatopoulou, Phd, Post Doc, University of West Attica, Athens, Greece

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: inspiratory muscle training; chronic heart failure; functional ability; dysfunctional breathing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Failure; Respiratory Aspiration
• Other Study ID Numbers: 51604/04-06-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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