Inspiratory Muscle Training in Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Effects of High Intensity Interval-Based Inspiratory Muscle Training in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839211
• Other study ID #: 3763-GOA
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: November 2022
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University, School of Physical Therapy and Rehabilitation	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Dokuz Eylül University, Scientific Research Projects Coordination Unit

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	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.	change from baseline to 8 weeks
Primary	Arterial stiffness	Arterial stiffness will be measured using a SphygmoCor device.	change from baseline to 8 weeks
Secondary	Maximal inspiratory pressure	Maximal inspiratory pressure (MIP) will be measured using an electronic mouth pressure device. A higher inspiratory pressure indicates better inspiratory muscle strength.	change from baseline to 8 weeks
Secondary	Maximal expiratory pressure	Maximal expiratory pressure (MEP) will be measured using an electronic mouth pressure device. A higher expiratory pressure indicates better expiratory muscle strength.	change from baseline to 8 weeks
Secondary	Respiratory muscle endurance	Respiratory muscle endurance will be measured using an inspiratory muscle training device (PowerBreath). Higher values indicate better respiratory muscle endurance.	change from baseline to 8 weeks
Secondary	Forced vital capacity (FVC)	Forced vital capacity will be measured using a spirometer	change from baseline to 8 weeks
Secondary	Forced expiratory volume in 1 second (FEV1)	The pulmonary function will be measured using a spirometer	change from baseline to 8 weeks
Secondary	Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%)	Forced expiratory flow at 25-75% of the vital capacity will be measured using a spirometer	change from baseline to 8 weeks
Secondary	Dyspnea	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.	change from baseline to 8 weeks
Secondary	Diaphragm thickness	Diaphragm thickness will be measured using a two-dimensional ultrasound machine.	change from baseline to 8 weeks
Secondary	Quadriceps muscle strength	Quadriceps muscle strength will be measured using a dynamometer. Higher values indicate better quadriceps muscle strength.	change from baseline to 8 weeks
Secondary	Balance	Balance performance will be assessed with a Balance Master System.	change from baseline to 8 weeks
Secondary	Functional capacity	Functional capacity will be assessed with 6 minute walk test.	change from baseline to 8 weeks
Secondary	Physical activity	Physical activity will be assessed with an activity monitor (SenseWear Armband) for consecutive 7 days.	change from baseline to 8 weeks
Secondary	Frailty	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.	change from baseline to 8 weeks
Secondary	Fatigue	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.	change from baseline to 8 weeks
Secondary	Disease-specific quality of life	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.	change from baseline to 8 weeks
Secondary	Health-related quality of life	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.	change from baseline to 8 weeks