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

NCT07104357 | Not Yet Recruiting DMC

• 1 other identifier: 51604/04-06-2025
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breathing Pattern Disorder

Keywords

inspiratory muscle training; dysfunctional breathing; functional ability; chronic heart failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Maximal inspiratory pressure

  From enrollment to the end of treatment at 4 weeks

• Functional Dyspnea

  From enrollment to the end of treatment at 4 weeks

• Health Related Quality of life

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Randomized controlled trial

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will receive standard care

Interventions

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

Randomized controlled trial

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• unstable angina
• recent acute myocardial infarction
• uncontrolled hypertension
• valve disease
• peripheral arterial disease
• MWT 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

Sponsors & Collaborators

• University of West Attica: lead

Study Officials

• Irini Grammatopoulou, Phd, Post Doc

  University of West Attica, Athens, Greece

  STUDY DIRECTOR

Central Study Contacts

Georgios Mitsiou, Phd

CONTACT

00306947888331; gmitsiou@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Teaching Staff

Model Details: This single-center, randomized controlled, single-blinded clinical trial is designed to investigate the effectiveness of inspiratory muscle training on breathing pattern and functional ability in patients with chronic heart failure

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 5, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share