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

Primary Purpose

Complications Due to Coronary Artery Bypass Graft

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High-intensity IMT + combined exercise
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications Due to Coronary Artery Bypass Graft

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High-intensity IMT + combined exercise

H-IMT sham + combined exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effects of high-intensity inspiratory muscle training on the inspiratory muscle endurance evaluated by using the traditional manovacuometry and the PowerBreathe device.
Effects of high-intensity inspiratory muscle training on lung function assessed by spirometry.
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.
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.
Effects of high-intensity inspiratory muscle training on the quality of life assessed by Minnesota Living with Heart Failure questionnaire (MLHFQ)
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.
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.
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.
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.
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

Full Information

First Posted
August 21, 2016
Last Updated
October 9, 2018
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT02885077
Brief Title
Effects of High-intensity Inspiratory Muscle Training in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Official Title
Effects of High-intensity Inspiratory Muscle Training Associated With Aerobic and Resistance Exercise in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications Due to Coronary Artery Bypass Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity IMT + combined exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
H-IMT sham + combined exercise
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High-intensity IMT + combined exercise
Other Intervention Name(s)
Sham Control H-IMT + combined exercise
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
Effects of high-intensity inspiratory muscle training on lung function assessed by spirometry.
Time Frame
Finalized study (12 weeks)
Title
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)
Title
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)
Title
Effects of high-intensity inspiratory muscle training on the quality of life assessed by Minnesota Living with Heart Failure questionnaire (MLHFQ)
Description
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.
Time Frame
Finalized study (12 weeks)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Hospital of Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30581100
Citation
Dos Santos TD, Pereira SN, Portela LOC, Cardoso DM, Lago PD, Dos Santos Guarda N, Moresco RN, Pereira MB, de Albuquerque IM. Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int J Cardiol. 2019 Mar 15;279:40-46. doi: 10.1016/j.ijcard.2018.12.013. Epub 2018 Dec 10.
Results Reference
derived

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

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