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Clinical Trials/NCT04834336
NCT04834336
Not yet recruiting
Not Applicable

Effects of Inspiratory Muscle Training in Patients With Acute Decompensated Heart Failure

Dokuz Eylul University0 sites28 target enrollmentJanuary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Decompensated Heart Failure
Sponsor
Dokuz Eylul University
Enrollment
28
Primary Endpoint
Maximal Inspiratory Pressure
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. However, the effects of inspiratory muscle training in hospitalized patients with ADHF have been not known. The aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with ADHF.

Detailed Description

The participants will randomly be allocated into two groups: (1) Physical training plus inspiratory muscle training, (2) Physical training Participants in the physical training plus inspiratory muscle training group will perform inspiratory muscle training and physical training. Inspiratory muscle training will be applied with an electronic device. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, the inspiratory muscle training will be carried out twice a day with mild to moderate whereas physical training will be carried out once a day. The physical training group will perform only physical training. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, physical training will be carried out once a day. For the safety and feasibility of inspiratory muscle training, data will be collected daily during the hospitalization. For effects of inspiratory muscle training, data will be collected at baseline and hospital discharge.

Registry
clinicaltrials.gov
Start Date
January 15, 2023
End Date
April 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aylin Tanriverdi

Research assistant

Dokuz Eylul University

Eligibility Criteria

Inclusion Criteria

  • The management of a diagnosis of ADHF over 24 hours in a hospital setting
  • Hemodynamic stability
  • The independence of basic activities of daily life before admission

Exclusion Criteria

  • Acute myocardial infarction
  • Congenital heart disease
  • Endocarditis, miyocarditis or pericarditis
  • Morbid obesity
  • Already participating in cardiac rehabilitation

Outcomes

Primary Outcomes

Maximal Inspiratory Pressure

Time Frame: baseline and hospital discharge, an average of 4 to 10 days

Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O)

Secondary Outcomes

  • New York Heart Association Functional Classification(baseline and hospital discharge, an average of 4 to 10 days)
  • Adverse events(During the hospitalization, daily, during an average of 4 to 10 days)
  • Recruitment rate(During the hospitalization, daily, during an average of 4 to 10 days)
  • Retention rate(During the hospitalization, daily, during an average of 4 to 10 days)
  • Physical Performance(baseline and hospital discharge, an average of 4 to 10 days)
  • Frailty(baseline and hospital discharge, an average of 4 to 10 days)
  • Cardiac autonomic function(baseline and hospital discharge, an average of 4 to 10 days)
  • Arterial Stiffness(baseline and hospital discharge, an average of 4 to 10 days)
  • Dyspnea(baseline and hospital discharge, an average of 4 to 10 days)
  • Hand Grip Strength(baseline and hospital discharge, an average of 4 to 10 days)
  • Disability(baseline and hospital discharge, an average of 4 to 10 days)
  • One-year mortality(one year after discharge)
  • Adherence rate(During the hospitalization, daily, during an average of 4 to 10 days)

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