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Inspiratory Muscle Training in Heart Failure

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training
Sham inspiratory muscle training
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory muscle training

Sham inspiratory muscle training

Arm Description

High-intensity interval-based inspiratory muscle training

Unloaded inspiratory muscle training

Outcomes

Primary Outcome Measures

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.
Arterial stiffness
Arterial stiffness will be measured using a SphygmoCor device.

Secondary Outcome Measures

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.
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.
Respiratory muscle endurance
Respiratory muscle endurance will be measured using an inspiratory muscle training device (PowerBreath). Higher values indicate better respiratory muscle endurance.
Forced vital capacity (FVC)
Forced vital capacity will be measured using a spirometer
Forced expiratory volume in 1 second (FEV1)
The pulmonary function will be measured using a spirometer
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
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.
Diaphragm thickness
Diaphragm thickness will be measured using a two-dimensional ultrasound machine.
Quadriceps muscle strength
Quadriceps muscle strength will be measured using a dynamometer. Higher values indicate better quadriceps muscle strength.
Balance
Balance performance will be assessed with a Balance Master System.
Functional capacity
Functional capacity will be assessed with 6 minute walk test.
Physical activity
Physical activity will be assessed with an activity monitor (SenseWear Armband) for consecutive 7 days.
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.
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.
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.
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.

Full Information

First Posted
April 6, 2021
Last Updated
November 21, 2022
Sponsor
Dokuz Eylul University
Collaborators
Dokuz Eylül University, Scientific Research Projects Coordination Unit
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1. Study Identification

Unique Protocol Identification Number
NCT04839211
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
Dokuz Eylül University, Scientific Research Projects Coordination Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sema Savci
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Inspiratory Muscle Training in Heart Failure

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