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NCT Number: NCT02885077

Effects of High-intensity Inspiratory Muscle Training in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Even with the advances in clinical therapy and percutaneous interventions, coronary artery bypass grafting (CABG) is still widely used in the treatment of patients with coronary artery disease (CAD). However, it is a complex procedure that triggers important organic implications especially on pulmonary function. In relation to the treatment of patients undergoing CABG, the recovery is linked to the cardiac rehabilitation programs. These programs can also be associated with other muscle training measures, among these there is inspiratory muscle training (IMT). Most studies has been implemented moderate-intensity IMT daily, but there are few studies about the effects of high intensity training loads performed on alternate days. In this context, is justified the use of a device such as the recent Powerbreathe, which uses higher training loads that would provide greatest benefits, whereas the magnitude of the response to training tends to increase with load.

OBJECTIVE: To investigate the efficiency of high intensity IMT associated with combined aerobic and resistance training on maximal exercise capacity, submaximal exercise capacity, respiratory muscle strenght, pulmonary function, oxidative stress, quality of life and endothelial function in patients who underwent CABG in phase II cardiac rehabilitation program.

METHODOLOGY: This is a clinical trials, controlled, randomized,double-blind being developed in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria (HUSM), Santa Maria, RS, Brazil. Patients will undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and digital manovacuometry), as well on the maximal exercise capacity (Ergospirometry), submaximal functional capacity (6MWT and 6MST), of quality of live (MLHFQ) of Oxidative stress and endothelial function (blood biomarkers). After the evaluation will be randomly allocated into two groups: the control group will perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group cardiac rehabilitation associated with the IMT High-intensity. The intervention will last twelve weeks for both groups and after this phase patients will be submitted again to the assessment tools.

EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation (phase II) after coronary artery bypass surgery patients.

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Key information

Conditions

Complications Due to Coronary Artery Bypass Graft

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing CABG up to three weeks before the initiation of the study, a clinical course without complications during hospitalization
  • Clinically stable
  • The absence of smoking (previous or current).

Exclusion criteria

  • Unstable angina
  • Myocardial infarction and heart surgery up to three months before the survey;
  • Chronic respiratory diseases
  • Hemodynamic instability
  • Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises
  • Psychological and / or cognitive impairments that restrict them to respond to questionnaires.

Treatment and study plan

High-intensity IMT + combined exercise

Device

Other names: Sham Control H-IMT + combined exercise

Primary outcomes

  1. Effects of high-intensity inspiratory muscle training on the functional capacity assessed by cardiopulmonary exercise test (CPT) and measured by VO2 peak.

    Time frame: Finalized study (12 weeks)

Secondary outcomes

  1. Effects of high-intensity inspiratory muscle training on the inspiratory muscle endurance evaluated by using the traditional manovacuometry and the PowerBreathe device.

    Time frame: Finalized study (12 weeks)

  2. Effects of high-intensity inspiratory muscle training on lung function assessed by spirometry.

    Time frame: Finalized study (12 weeks)

  3. Effects of high-intensity inspiratory muscle training on the submaximal functional assessed by six-minute walk test (6MWT) and measured with six minute walk distance.

    Time frame: Finalized study (12 weeks)

  4. Effects of high-intensity inspiratory muscle training on the submaximal functional capacity assessed by six-minute step test (6MST) and measured with the number of steps.

    Time frame: Finalized study (12 weeks)

  5. Effects of high-intensity inspiratory muscle training on the quality of life assessed by Minnesota Living with Heart Failure questionnaire (MLHFQ)

    Time frame: Finalized study (12 weeks)

    The MLHFQ is a questionnaire validated for the Brazilian population, consisting of 21 questions regarding limitations frequently associated with the extent to which heart failure has affected patient's lives in the previous month. Each question is attributed a value from 0 (zero) to 5 (five), with the highest score indicating worse quality of life. The total score is calculated by adding the 21 items, with a possible interval between 0 and 105.

  6. Effects of high-intensity inspiratory muscle training on the oxidative stress assessed by analysis of advanced oxidation protein products (AOPP). Plasma levels of AOPP assessed by on automated analyzer Mindray® expressed as µmol/L.

    Time frame: Finalized study (12 weeks)

  7. Effects of high-intensity inspiratory muscle training on the oxidative stress assessed by analysis of products of ferric reducing antioxidant power (FRAP). Plasma levels of FRAP assesssed by automated analyzer Mindray® expressed as µmol/L.

    Time frame: Finalized study (12 weeks)

  8. Effects of high-intensity inspiratory muscle training on the endothelial function assessed by analysis of nitric oxide (NOx). Plasma levels of NOx assessed automated analyzer Mindray® expressed as µmol/L.

    Time frame: Finalized study (12 weeks)

  9. Effects of high-intensity inspiratory muscle training on the Inflammatory profile assessed by through ultra-sensitive C-reactive protein (us-CRP) on automated analyzer Mindray® expressed as mg/dL

    Time frame: Finalized study (12 weeks)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Maria

Other

Registry information

Official study title

Effects of High-intensity Inspiratory Muscle Training Associated With Aerobic and Resistance Exercise in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2016
Registry last updated
Oct 11, 2018

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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