Clinical trial NCT04839211: Inspiratory Muscle Training in Heart Failure
Official title: Effects of High Intensity Interval-Based Inspiratory Muscle Training in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylül University, Scientific Research Projects Coordination Unit
First posted: 2021-04-09
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Heart rate variability
timeFrame: change from baseline to 8 weeks
measure: Arterial stiffness
timeFrame: change from baseline to 8 weeks
Secondary outcomes:
measure: Maximal inspiratory pressure
timeFrame: change from baseline to 8 weeks
measure: Maximal expiratory pressure
timeFrame: change from baseline to 8 weeks
measure: Respiratory muscle endurance
timeFrame: change from baseline to 8 weeks
measure: Forced vital capacity (FVC)
timeFrame: change from baseline to 8 weeks
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: change from baseline to 8 weeks
measure: Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%)
timeFrame: change from baseline to 8 weeks
measure: Dyspnea
timeFrame: change from baseline to 8 weeks
measure: Diaphragm thickness
timeFrame: change from baseline to 8 weeks
measure: Quadriceps muscle strength
timeFrame: change from baseline to 8 weeks
measure: Balance
timeFrame: change from baseline to 8 weeks
measure: Functional capacity
timeFrame: change from baseline to 8 weeks
measure: Physical activity
timeFrame: change from baseline to 8 weeks
measure: Frailty
timeFrame: change from baseline to 8 weeks
measure: Fatigue
timeFrame: change from baseline to 8 weeks
measure: Disease-specific quality of life
timeFrame: change from baseline to 8 weeks
measure: Health-related quality of life
timeFrame: change from baseline to 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Study officials:
affiliation: Dokuz Eylul University
name: Sema Savci
role: STUDY_DIRECTOR
References: