Clinical trial NCT04834336: Inspiratory Muscle Training in Acute Decompensated Heart Failure
Official title: Effects of Inspiratory Muscle Training in Patients With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Decompensated Heart Failure
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximal Inspiratory Pressure
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
Secondary outcomes:
measure: Adverse events
timeFrame: During the hospitalization, daily, during an average of 4 to 10 days
measure: Recruitment rate
timeFrame: During the hospitalization, daily, during an average of 4 to 10 days
measure: Adherence rate
timeFrame: During the hospitalization, daily, during an average of 4 to 10 days
measure: Retention rate
timeFrame: During the hospitalization, daily, during an average of 4 to 10 days
measure: New York Heart Association Functional Classification
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Dyspnea
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Hand Grip Strength
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Physical Performance
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Frailty
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Cardiac autonomic function
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Arterial Stiffness
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: Disability
timeFrame: baseline and hospital discharge, an average of 4 to 10 days
measure: One-year mortality
timeFrame: one year after discharge
Other outcomes:
Locations:
Study officials:
affiliation: Dokuz Eylul University
name: Sema Savci, Prof
role: STUDY_DIRECTOR
References: