Inspiratory Muscle Training in Acute Decompensated Heart Failure

Effects of Inspiratory Muscle Training in Patients With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: inspiratory muscle training device; Other: Physical training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aylin Tanriverdi; Phone Number: +905352359989; Email: tanrverdiaylin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physical training plus inspiratory muscle training; 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; 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.
ACTIVE_COMPARATOR: Physical training; 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; Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Study Director: Sema Savci, Prof, Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2023
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 5883-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No