Inspiratory Muscle Training in Heart Failure

NCT ID: NCT04839211

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2022-11-21

Brief Summary

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.

Detailed 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.

Conditions

Chronic Heart Failure

Study Design

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

Study Groups

Inspiratory muscle training

High-intensity interval-based inspiratory muscle training

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: DEVICE

Inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the highest tolerable load and will be gradually increased.

Sham inspiratory muscle training

Unloaded inspiratory muscle training

Group Type: SHAM_COMPARATOR

Sham inspiratory muscle training

Intervention Type: DEVICE

Sham inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the unloaded.

Interventions

Inspiratory muscle training

Inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the highest tolerable load and will be gradually increased.

Intervention Type: DEVICE

Sham inspiratory muscle training

Sham inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the unloaded.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylül University, Scientific Research Projects Coordination Unit

UNKNOWN

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Aylin Tanriverdi

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sema Savci

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Tanriverdi A, Savci S, Ozcan Kahraman B, Odaman H, Ozpelit E, Senturk B, Ozsoy I, Baran A, Akdeniz B, Acar S, Balci A. Effects of high intensity interval-based inspiratory muscle training in patients with heart failure: A single-blind randomized controlled trial. Heart Lung. 2023 Nov-Dec;62:1-8. doi: 10.1016/j.hrtlng.2023.05.011. Epub 2023 Jun 7.

Reference Type: DERIVED

PMID: 37285766 (View on PubMed)

Other Identifiers

3763-GOA

Identifier Type: -

Identifier Source: org_study_id