Inspiratory Muscle Training in Acute Decompensated Heart Failure

NCT ID: NCT04834336

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-04-01

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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

inspiratory muscle training device

Intervention Type: DEVICE

Inspiratory muscle training will be performed with an inspiratory muscle training device.

Physical training

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Physical training

Intervention Type: OTHER

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

Interventions

inspiratory muscle training device

Inspiratory muscle training will be performed with an inspiratory muscle training device.

Intervention Type: DEVICE

Physical training

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Aylin Tanriverdi

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sema Savci, Prof

Role: STUDY_DIRECTOR

Dokuz Eylul University

Central Contacts

Aylin Tanriverdi

Role: CONTACT

tanrverdiaylin@gmail.com

+905352359989

Other Identifiers

5883-GOA

Identifier Type: -

Identifier Source: org_study_id