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

NCT02885077 | Completed DMC

• 1 other identifier: 16149813.3.0000.5346
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications Due to Coronary Artery Bypass Graft

Outcome Measures

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.

  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.

  Finalized study (12 weeks)

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

  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.

  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.

  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)

  Finalized study (12 weeks)

Study Arms (2)

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.

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.

Device: High-intensity IMT + combined exercise

Interventions

High-intensity IMT + combined exercise DEVICE

Also known as: Sham Control H-IMT + combined exercise

H-IMT sham + combined exercise; High-intensity IMT + combined exercise

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

University Hospital of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30581100 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of high-intensity inspiratory muscle training in patients undergoing coronary artery bypass grafting surgery

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: August 31, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

BR (1)