Inspiratory Muscle Training in Heart Failure
- Conditions
- Chronic Heart Failure
- Interventions
- Device: Sham inspiratory muscle trainingDevice: Inspiratory muscle training
- Registration Number
- NCT04839211
- Lead Sponsor
- Dokuz Eylul University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham inspiratory muscle training Sham inspiratory muscle training Unloaded inspiratory muscle training Inspiratory muscle training Inspiratory muscle training High-intensity interval-based inspiratory muscle training
- Primary Outcome Measures
Name Time Method Arterial stiffness change from baseline to 8 weeks Arterial stiffness will be measured using a SphygmoCor device.
Heart rate variability change from baseline to 8 weeks Heart rate variability analysis, which gives information about the cardiac autonomic function, will be obtained from a short-term 5-min ECG recording using a SphygmoCor device.
- Secondary Outcome Measures
Name Time Method Forced vital capacity (FVC) change from baseline to 8 weeks Forced vital capacity will be measured using a spirometer
Diaphragm thickness change from baseline to 8 weeks Diaphragm thickness will be measured using a two-dimensional ultrasound machine.
Functional capacity change from baseline to 8 weeks Functional capacity will be assessed with 6 minute walk test.
Maximal inspiratory pressure change from baseline to 8 weeks Maximal inspiratory pressure (MIP) will be measured using an electronic mouth pressure device. A higher inspiratory pressure indicates better inspiratory muscle strength.
Maximal expiratory pressure change from baseline to 8 weeks Maximal expiratory pressure (MEP) will be measured using an electronic mouth pressure device. A higher expiratory pressure indicates better expiratory muscle strength.
Dyspnea change from baseline to 8 weeks Dyspnea will be assessed with the modified Medical Research Council (mMRC) scale.
mMRC is a scale of 5 items (0-4). Higher scores indicate higher dyspnea perception.Disease-specific quality of life change from baseline to 8 weeks Disease-specific quality of life will be assessed with Minnesota Living with Heart Failure Questionnaire. It is a 21-item questionnaire. Each item is scored from 0-5 (a 5-point severity scale). The highest score is 105.
Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%) change from baseline to 8 weeks Forced expiratory flow at 25-75% of the vital capacity will be measured using a spirometer
Quadriceps muscle strength change from baseline to 8 weeks Quadriceps muscle strength will be measured using a dynamometer. Higher values indicate better quadriceps muscle strength.
Fatigue change from baseline to 8 weeks Fatigue will be assessed with Fatigue Impact Scale. Fatigue Impact Scale is a 40-item questionnaire. Each item is scored from 0-4 (a 4-point severity scale). The highest score is 160.
Forced expiratory volume in 1 second (FEV1) change from baseline to 8 weeks The pulmonary function will be measured using a spirometer
Respiratory muscle endurance change from baseline to 8 weeks Respiratory muscle endurance will be measured using an inspiratory muscle training device (PowerBreath). Higher values indicate better respiratory muscle endurance.
Balance change from baseline to 8 weeks Balance performance will be assessed with a Balance Master System.
Physical activity change from baseline to 8 weeks Physical activity will be assessed with an activity monitor (SenseWear Armband) for consecutive 7 days.
Frailty change from baseline to 8 weeks Physical frailty will be assessed with Field Frailty Phenotype. Field Frailty Phenotype consists of 5 criteria and scores 0 to 5. A score of 3-5 indicates frailty.
Health-related quality of life change from baseline to 8 weeks Health-related quality of life will be assessed with Short-Form 36 Health Survey Questionnaire (SF-36). SF-36 consists of 8 domains. Higher scores indicate a better health-related quality of life.
Trial Locations
- Locations (1)
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
🇹🇷Izmir, Turkey