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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
Inspiratory muscle training will be performed with an inspiratory muscle training device.
Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.
Maximal Inspiratory Pressure
Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O)
Time frame: baseline and hospital discharge, an average of 4 to 10 days
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.
Time frame: 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 (%)
Time frame: 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 (%)
Time frame: 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 (%)
Time frame: 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.
Time frame: baseline and hospital discharge, an average of 4 to 10 days
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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.
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Hand Grip Strength
Hand grip strength will be measured by a dynamometer.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and hospital discharge, an average of 4 to 10 days
One-year mortality
The mortality rate during the first year following hospital discharge
Time frame: one year after discharge