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NCT Number: NCT07104357

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

Device

Participants will perform 20 sessions of respiratory muscle strengthening (20 minutes at 30-60% of MIP), using the Threshold Inspiratory Muscle Training device

Primary outcomes

  1. Diaphragmatic Thickness

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  2. Dysfunctional breathing

    Time frame: From enrollment to the end of treatment at 4 weeks

    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.

  3. Functional ability

    Time frame: From enrollment to the end of treatment at 4 weeks

    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.

Secondary outcomes

  1. Maximal inspiratory pressure

    Time frame: From enrollment to the end of treatment at 4 weeks

    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.

  2. Functional Dyspnea

    Time frame: From enrollment to the end of treatment at 4 weeks

    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).

  3. Health Related Quality of life

    Time frame: From enrollment to the end of treatment at 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Mitsiou, Phd

CONTACT

[email protected]

00306947888331

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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