Inspiratory Muscle Training in Heart Failure

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: Sham inspiratory muscle training; Device: Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT04839211

3763-GOA

Details and patient eligibility

About

The aim of this study is to investigate the potential effects of inspiratory muscle training on cardiovascular, respiratory, physical, and psychosocial functions in patients with heart failure.

Full description

Heart failure is a syndrome that leads to decreased cardiac output, inflammation, increased catabolism, and prolonged immobilization, causing inspiratory muscle weakness. Cardiac rehabilitation is a well-known treatment approach in heart failure however, the participation rate in cardiac rehabilitation is low. Therefore, inspiratory muscle training may serve as an alternative approach in patients with heart failure.

Patients will be randomly allocated into the inspiratory muscle training group and control group. The inspiratory muscle training (IMT) group will carry out IMT sessions three days per week for 8 weeks by using an inspiratory threshold loading device. Each session will consist of seven cycles including 2 min of breathing on an inspiratory loading device followed by 1 min of rest and will last 21 min. IMT will be performed at the tolerable maximum load for each 2-min work interval and will be progressively increased over the 8 weeks. The control group will perform unloaded IMT by using an inspiratory threshold loading device during all training sessions. Data will be collected before and after the treatment by a masked outcome assessor.

Enrollment: 34 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of heart failure with reduced ejection fraction
• Clinically stable
• Functional class II-III according to the New York Heart Association functional classification
• Having inspiratory muscle weakness (MIP<70%)
• Volunteer to participation

Exclusion criteria

• Congenital heart disease
• Severe valvular heart disease
• Cardiac device such as implantable cardioverter defibrillator or cardiac resynchronization therapy
• Neurological disease
• Conditions that may limit the physical mobility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Inspiratory muscle training

Experimental group

Description:

High-intensity interval-based inspiratory muscle training

Treatment:

Device: Inspiratory muscle training

Sham inspiratory muscle training

Sham Comparator group

Description:

Unloaded inspiratory muscle training

Treatment:

Device: Sham inspiratory muscle training