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Completed

NCT Number: NCT04839211

Inspiratory Muscle Training in Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

Device

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

Device

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 outcomes

  1. 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.

  2. Arterial stiffness

    Time frame: change from baseline to 8 weeks

    Arterial stiffness will be measured using a SphygmoCor device.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Forced vital capacity (FVC)

    Time frame: change from baseline to 8 weeks

    Forced vital capacity will be measured using a spirometer

  5. Forced expiratory volume in 1 second (FEV1)

    Time frame: change from baseline to 8 weeks

    The pulmonary function will be measured using a spirometer

  6. Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%)

    Time frame: change from baseline to 8 weeks

    Forced expiratory flow at 25-75% of the vital capacity will be measured using a spirometer

  7. 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.

  8. Diaphragm thickness

    Time frame: change from baseline to 8 weeks

    Diaphragm thickness will be measured using a two-dimensional ultrasound machine.

  9. Quadriceps muscle strength

    Time frame: change from baseline to 8 weeks

    Quadriceps muscle strength will be measured using a dynamometer. Higher values indicate better quadriceps muscle strength.

  10. Balance

    Time frame: change from baseline to 8 weeks

    Balance performance will be assessed with a Balance Master System.

  11. Functional capacity

    Time frame: change from baseline to 8 weeks

    Functional capacity will be assessed with 6 minute walk test.

  12. Physical activity

    Time frame: change from baseline to 8 weeks

    Physical activity will be assessed with an activity monitor (SenseWear Armband) for consecutive 7 days.

  13. Frailty

    Time frame: 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.

  14. 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.

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Dokuz Eylül University, Scientific Research Projects Coordination Unit

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2021
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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