Acute Decompensated Heart Failure
Conditions
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.
Interventions
Inspiratory muscle training will be performed with an inspiratory muscle training device.
OTHERPhysical training
Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.
Sponsors
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Inspiratory Pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | During the hospitalization, daily, during an average of 4 to 10 days | 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. |
| Recruitment rate | During the hospitalization, daily, during an average of 4 to 10 days | The number of participants divided by the total number of eligible patients (%) |
| Adherence rate | During the hospitalization, daily, during an average of 4 to 10 days | The number of training sessions divided by the total number of potential sessions (%) |
| Retention rate | During the hospitalization, daily, during an average of 4 to 10 days | The number of patients who complete the protocol divided by the total number of patients included in the study (%) |
| New York Heart Association Functional Classification | baseline and hospital discharge, an average of 4 to 10 days | 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. |
| Hand Grip Strength | baseline and hospital discharge, an average of 4 to 10 days | Hand grip strength will be measured by a dynamometer. |
| Dyspnea | baseline and hospital discharge, an average of 4 to 10 days | Dyspnea will be assessed by using the Modified Medical Research Council Scale. It is a 5-item scale. Higher scores indicate higher dyspnea perception. |
| Frailty | baseline and hospital discharge, an average of 4 to 10 days | 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 | baseline and hospital discharge, an average of 4 to 10 days | Cardiac autonomic function will be evaluated with heart rate variability analysis by using a SphygmoCor ® device. |
| Arterial Stiffness | baseline and hospital discharge, an average of 4 to 10 days | Arterial stiffness will be measured by augmentation index using a SphygmoCor® device. |
| Disability | baseline and hospital discharge, an average of 4 to 10 days | 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. |
| One-year mortality | one year after discharge | The mortality rate during the first year following hospital discharge |
| Physical Performance | baseline and hospital discharge, an average of 4 to 10 days | 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. |
Contacts
Primary ContactAylin Tanriverdi
Outcome results
None listed