Inspiratory Muscle Training in Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: inspiratory muscle training device
* Other: Physical training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical training plus inspiratory muscle training<br>Inspiratory Muscle Training (IMT) will be implemented by using the Power Breathe® device. IMT training will begin with mild to moderate intensity of maximal inspiratory pressure. It will be performed 6 to 10 breaths, 4 sets, and twice daily during the hospitalization when as soon as hemodynamic stability is provided. Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. | Device: inspiratory muscle training device<br>* Inspiratory muscle training will be performed with an inspiratory muscle training device.<br>Other: Physical training<br>* Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.<br>|
| Active Comparator: Physical training<br>Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. | Other: Physical training<br>* Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Inspiratory Pressure | Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O) | baseline and hospital discharge, an average of 4 to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | The number of adverse events resulting from the intervention will be noted. Adverse events include blood pressure greater than 170/100 mmHg, desaturation of oxygen greater than 4%, severe musculoskeletal and/or chest pain, dyspnea greater than 6 on the Borg scale, dizziness, nausea, vomiting, bleeding, loss or obstruction of the central or peripheral catheter. | During the hospitalization, daily, during an average of 4 to 10 days | 
| Recruitment rate | The number of participants divided by the total number of eligible patients (%) | During the hospitalization, daily, during an average of 4 to 10 days | 
| Adherence rate | The number of training sessions divided by the total number of potential sessions (%) | During the hospitalization, daily, during an average of 4 to 10 days | 
| Retention rate | The number of patients who complete the protocol divided by the total number of patients included in the study (%) | During the hospitalization, daily, during an average of 4 to 10 days | 
| New York Heart Association Functional Classification | Functional Classification will be assessed with New York Heart Association (NYHA) Functional Classification. The minimum value is 1 whereas the maximum value is 4. Higher scores indicate the lower functional class. | baseline and hospital discharge, an average of 4 to 10 days | 
| Dyspnea | Dyspnea will be assessed by using the Modified Medical Research Council Scale. It is a 5-item scale. Higher scores indicate higher dyspnea perception. | baseline and hospital discharge, an average of 4 to 10 days | 
| Hand Grip Strength | Hand grip strength will be measured by a dynamometer. | baseline and hospital discharge, an average of 4 to 10 days | 
| Physical Performance | Physical performance will be measured by Short Physical Performance Battery (SPPB). SPPB comprises 5 times sit-to-stand, standing balance and 4-m gait speed. The total score ranges from 0 to 12 and a higher score indicates better physical performance. | baseline and hospital discharge, an average of 4 to 10 days | 
| Frailty | Frailty will be assessed by using the Clinical Frailty Scale (CFS). CFS scores on a scale from 1 (very fit) to 9 (terminally ill). | baseline and hospital discharge, an average of 4 to 10 days | 
| Cardiac autonomic function | Cardiac autonomic function will be evaluated with heart rate variability analysis by using a SphygmoCor ® device. | baseline and hospital discharge, an average of 4 to 10 days | 
| Arterial Stiffness | Arterial stiffness will be measured by augmentation index using a SphygmoCor® device. | baseline and hospital discharge, an average of 4 to 10 days | 
| Disability | Disability will be assessed by using Barthel Index. It occurs 10 questions and the score ranges from 0 to 100. Higher scores indicate greater independence. | baseline and hospital discharge, an average of 4 to 10 days | 
| One-year mortality | The mortality rate during the first year following hospital discharge | one year after discharge |