Inspiratory Muscle Training in Acute Decompensated Heart Failure

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.

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.

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.

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.

Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.

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.

The number of patients who complete the protocol divided by the total number of patients included in the study (%)

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.

Dyspnea will be assessed by using the Modified Medical Research Council Scale. It is a 5-item scale. Higher scores indicate higher dyspnea perception.

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.

Frailty will be assessed by using the Clinical Frailty Scale (CFS). CFS scores on a scale from 1 (very fit) to 9 (terminally ill).

Cardiac autonomic function will be evaluated with heart rate variability analysis by using a SphygmoCor ® device.

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.

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