Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery

NCT ID: NCT03094923

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-12
• Study Completion Date: 2014-01-18

Brief Summary

This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on functional capacity, respiratory muscle strength, postoperative pulmonary complications and days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery (CABG).

Detailed Description

Patients undergoing coronary artery bypass graft surgery are at risk of postoperative pulmonary complications, which lead to increased postoperative morbidity and mortality.

A few studies have demonstrated that preoperative physical therapy has advantages over postoperative care in patients undergoing cardiac . In this way, this study aim to investigate the effects of preoperativeinspiratory muscle training in patients at high risk of postoperative pulmonary complications who were scheduled for coronary artery bypass graft surgery.

Conditions

Heart Diseases; Coronary Disease; Cardiovascular Diseases; Coronary Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Inspiratory muscle training

Inspiratory muscle training with threshold device and workloud 30% of the peak inpiratory preassure, during two weeks prior to surgery, seven days a week, twice a day, three sets of ten repetitions with supervision.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type: OTHER

The inspiratory muscle training (IMT) will be carried out in the IG with Threshold® IMT (Respironics New Jersey, Inc) consisting of a unidirectional flow control valve which assures the constant resistance (linear load) between 7 and 41cmH20.

The IMT will be carried out in the sitting position with a load of 30% of the MIP during the two weeks preceding the surgery, seven days a week, twice daily in three series of ten repetitions with a 30 second interval between series, under the supervision of a physiotherapist. A load of 15% of the MIP was used only on the first day of training in order for the individual to adapt to the equipment. Subsequently, the 30% MIP load will be applied and readjusted according to the new MIP values determined every four days.

Control group

Control group will receive a supportive educational component in the preoperative period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inspiratory Muscle Training

The inspiratory muscle training (IMT) will be carried out in the IG with Threshold® IMT (Respironics New Jersey, Inc) consisting of a unidirectional flow control valve which assures the constant resistance (linear load) between 7 and 41cmH20.

The IMT will be carried out in the sitting position with a load of 30% of the MIP during the two weeks preceding the surgery, seven days a week, twice daily in three series of ten repetitions with a 30 second interval between series, under the supervision of a physiotherapist. A load of 15% of the MIP was used only on the first day of training in order for the individual to adapt to the equipment. Subsequently, the 30% MIP load will be applied and readjusted according to the new MIP values determined every four days.

Intervention Type: OTHER

Other Intervention Names

Respiratory Muscle Training

Eligibility Criteria

Inclusion Criteria

• High-risk patients underwent primary elective CABG (Coronary artery bypass graft), High-risk will be defined as 2 or more the following: age>70 years; cough and expectoration; diabetes; smoker; COPD (Chronic Obstructive Pulmonary Disease)

Exclusion Criteria

• Uncontrolled arrhythmia,
• Decompensated heart failure,
• Unstable angina upon selection or during the inspiratory muscle training (IMT),
• Need for reoperation and association of another procedure during surgery (e.g. valve correction associated with CABG)
• Severe orthopedic or neurological conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the State of Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Kelly Cattelan Bonorino

Post graduation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1632008

Identifier Type: -

Identifier Source: org_study_id