Complications Due to Coronary Artery Bypass GraftNCT02885077
Effects of High-intensity Inspiratory Muscle Training in Patients Undergoing Coronary Artery Bypass Grafting Surgery
A study testing High-intensity IMT + combined exercise in people with Complications Due to Coronary Artery Bypass Graft, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Complications Due to Coronary Artery Bypass Graft
- What is being tested?
- High-intensity IMT + combined exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-intensity Inspiratory Muscle Training Associated With Aerobic and Resistance Exercise 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.
Read more
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.
- Being tested
- High-intensity IMT + combined exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity IMT + combined exerciseDevice
Also called Sham Control H-IMT + combined exercise
| Study group | Role | What they receive |
|---|---|---|
| High-intensity IMT + combined exercise | Experimental | 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. Receives: Device: High-intensity IMT + combined exercise |
| H-IMT sham + combined exercise | Sham comparator | 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. Receives: Device: High-intensity IMT + combined exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of high-intensity inspiratory muscle training on the functional capacity assessed by cardiopulmonary exercise test (CPT) and measured by VO2 peak.
Measured: Finalized study (12 weeks)
Secondary outcomes (9)
Effects of high-intensity inspiratory muscle training on the inspiratory muscle endurance evaluated by using the traditional manovacuometry and the PowerBreathe device.
Measured: Finalized study (12 weeks)
Effects of high-intensity inspiratory muscle training on lung function assessed by spirometry.
Measured: Finalized study (12 weeks)
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.
Measured: Finalized study (12 weeks)
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.
Measured: Finalized study (12 weeks)
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.
Measured: Finalized study (12 weeks)
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.
Measured: Finalized study (12 weeks)
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.
Measured: Finalized study (12 weeks)
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.
Measured: Finalized study (12 weeks)
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
Measured: Finalized study (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications Due to Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Martins de Albuquerque, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885077
- Sponsor's protocol ID
- 16149813.3.0000.5346
- Status last verified
- Oct 2018
- First submitted
- 21 Aug 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 30581100
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Inspiratory Muscle Training Associated With Aerobic and Resistance Exercise in Patients Undergoing Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT02885077
- Acronym / sponsor ID
- 16149813.3.0000.5346
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity IMT + combined exercise | Experimental | Device: High-intensity IMT + combined exerciseParticipants 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. |
| H-IMT sham + combined exercise | Sham comparator | Device: High-intensity IMT + combined exerciseParticipants 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity IMT + combined exerciseAlso: Sham Control H-IMT + combined exercise | Device | H-IMT sham + combined exercise, High-intensity IMT + combined exercise |
Primary outcome
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)
9 secondary outcomes
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)
Effects of high-intensity inspiratory muscle training on lung function assessed by spirometry.
Time frame: Finalized study (12 weeks)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 30581100Dos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity IMT + combined exercise in people with Complications Due to Coronary Artery Bypass Graft, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02885077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.