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Not yet recruiting NCT07104357

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

No phase Interventional Breathing Pattern Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiratory muscle training.
Who it may be relevant to
Registry conditions: Breathing Pattern Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

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

Interventions

  • 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

Primary outcome measures

  • Diaphragmatic Thickness [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Dysfunctional breathing [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Functional ability [Time frame: From enrollment to the end of treatment at 4 weeks]
Secondary outcome measures (3)
  • Maximal inspiratory pressure [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Functional Dyspnea [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Health Related Quality of life [Time frame: From enrollment to the end of treatment at 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07104357 · 51604/04-06-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗