Inspiratory Muscle Training in Acute Decompensated Heart Failure

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04834336
• Other study ID #: 5883-GOA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2022
• Source: Dokuz Eylul University
• Contact: Aylin Tanriverdi
• Phone: +905352359989
• Email: tanrverdiaylin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• inspiratory muscle training device
Inspiratory muscle training will be performed with an inspiratory muscle training device.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hand Grip Strength	Hand grip strength will be measured by a dynamometer.	baseline and hospital discharge, an average of 4 to 10 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	One-year mortality	The mortality rate during the first year following hospital discharge	one year after discharge