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

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ClinicalTrials.gov Identifier: NCT02885077
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Isabella Martins de Albuquerque, Universidade Federal de Santa Maria

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Complications Due to Coronary Artery Bypass Graft Device: High-intensity IMT + combined exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of High-intensity Inspiratory Muscle Training Associated With Aerobic and Resistance Exercise in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study Start Date : May 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-intensity IMT + combined exercise
Participants will perform 12 weeks of IMT strength training is achieved with a device with linear load pressure with a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). Training will progress to 80% maximal inspiratory pressure (PiMax). IMT will perform for 12 weeks with two sessions per week. The training protocol will consists of five series with ten repetitions with two minutes or according to patient feedback using the modified Borg scale.The initial charge of training will be 50% of PiMax in the first 2 weeks, with an increase of 55% of PiMax in the 3 week, 60% of PiMax in the 4 week, 65% of PiMax in the 5 week, 70% of PiMax in the 6 week, 75% of PiMax in the 7 week and 80% of PiMax in the 8 week. After the 9 and 12 week training period, the PiMax measurements will be performed weekly to keep 80% of the new PiMax.
Device: High-intensity IMT + combined exercise
Other Name: Sham Control H-IMT + combined exercise

Sham Comparator: H-IMT sham + combined exercise
Participants will perform 12 weeks of IMT strength training is achieved with a device with linear load pressure with a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). The sham group will perform for 12 weeks with two sessions per week. The protocol will consists of five series with ten repetitions with two minutes and will train at a constant inspiratory load of no more than 10% of their initial Pimax.
Device: High-intensity IMT + combined exercise
Other Name: Sham Control H-IMT + combined exercise




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885077


Locations
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Brazil
University Hospital of Santa Maria
Santa Maria, Rio Grande Do Sul, Brazil
Sponsors and Collaborators
Universidade Federal de Santa Maria

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isabella Martins de Albuquerque, Effects of high-intensity inspiratory muscle training in patients undergoing coronary artery bypass grafting surgery, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT02885077     History of Changes
Other Study ID Numbers: 16149813.3.0000.5346
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes