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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of West Attica

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

unstable angina

recent acute myocardial infarction

uncontrolled hypertension

valve disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Randomized controlled trialExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of treatment at 4 weeks
2

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.

Time frame
From enrollment to the end of treatment at 4 weeks
3

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.

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

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 4 weeks
2

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).

Time frame
From enrollment to the end of treatment at 4 weeks
3

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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