Chronic Heart Failure
Conditions
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.
Interventions
DEVICEInspiratory 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.
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.
Sponsors
Dokuz Eylül University, Scientific Research Projects Coordination Unit
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Arterial stiffness | change from baseline to 8 weeks | Arterial stiffness will be measured using a SphygmoCor device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Forced vital capacity (FVC) | change from baseline to 8 weeks | Forced vital capacity will be measured using a spirometer |
| Forced expiratory volume in 1 second (FEV1) | change from baseline to 8 weeks | The pulmonary function will be measured using a spirometer |
| 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 |
| 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. |
| Diaphragm thickness | change from baseline to 8 weeks | Diaphragm thickness will be measured using a two-dimensional ultrasound machine. |
| 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. |
| 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. |
| Functional capacity | change from baseline to 8 weeks | Functional capacity will be assessed with 6 minute walk test. |
| 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. |
| 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. |
| 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. |
| 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. |
| Balance | change from baseline to 8 weeks | Balance performance will be assessed with a Balance Master System. |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed