- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04839211
Inspiratory Muscle Training in Heart Failure
Effects of High Intensity Interval-Based Inspiratory Muscle Training in Patients With Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Izmir, Turkey, 35340
- Dokuz Eylul University, School of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inspiratory muscle training
High-intensity interval-based inspiratory muscle training
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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 Comparator: Sham inspiratory muscle training
Unloaded inspiratory muscle training
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: 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.
|
change from baseline to 8 weeks
|
Arterial stiffness
Time Frame: change from baseline to 8 weeks
|
Arterial stiffness will be measured using a SphygmoCor device.
|
change from baseline to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal inspiratory pressure
Time Frame: 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.
|
change from baseline to 8 weeks
|
Maximal expiratory pressure
Time Frame: 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.
|
change from baseline to 8 weeks
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Respiratory muscle endurance
Time Frame: 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.
|
change from baseline to 8 weeks
|
Forced vital capacity (FVC)
Time Frame: change from baseline to 8 weeks
|
Forced vital capacity will be measured using a spirometer
|
change from baseline to 8 weeks
|
Forced expiratory volume in 1 second (FEV1)
Time Frame: change from baseline to 8 weeks
|
The pulmonary function will be measured using a spirometer
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change from baseline to 8 weeks
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Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%)
Time Frame: change from baseline to 8 weeks
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Forced expiratory flow at 25-75% of the vital capacity will be measured using a spirometer
|
change from baseline to 8 weeks
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Dyspnea
Time Frame: 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. |
change from baseline to 8 weeks
|
Diaphragm thickness
Time Frame: change from baseline to 8 weeks
|
Diaphragm thickness will be measured using a two-dimensional ultrasound machine.
|
change from baseline to 8 weeks
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Quadriceps muscle strength
Time Frame: change from baseline to 8 weeks
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Quadriceps muscle strength will be measured using a dynamometer.
Higher values indicate better quadriceps muscle strength.
|
change from baseline to 8 weeks
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Balance
Time Frame: change from baseline to 8 weeks
|
Balance performance will be assessed with a Balance Master System.
|
change from baseline to 8 weeks
|
Functional capacity
Time Frame: change from baseline to 8 weeks
|
Functional capacity will be assessed with 6 minute walk test.
|
change from baseline to 8 weeks
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Physical activity
Time Frame: change from baseline to 8 weeks
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Physical activity will be assessed with an activity monitor (SenseWear Armband) for consecutive 7 days.
|
change from baseline to 8 weeks
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Frailty
Time Frame: change from baseline to 8 weeks
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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
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Fatigue
Time Frame: 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.
|
change from baseline to 8 weeks
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Disease-specific quality of life
Time Frame: 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.
|
change from baseline to 8 weeks
|
Health-related quality of life
Time Frame: 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.
|
change from baseline to 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sema Savci, Dokuz Eylül University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3763-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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