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

NCT03094923 | Completed DMC

• 1 other identifier: 1632008
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pulmonary Complications

  The postoperative pulmonary complications (PPC) will be classified according to an ordinal scale from 1 to 4 , as proposed by Kroenke (2002). The PPCs will be defined as clinically significant if the individual presented two or more Level 2 items or one or more Level 3 and/or 4 items. The Level 1 items were considered subclinical.

  1 month

Secondary Outcomes (3)

• Respiratory Muscle Strenght

  1 month

• Functional Capacity

  1 month

• Lenght of hospital stay hospitalization

  1 month

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

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.

Other: Inspiratory Muscle Training

Control group

NO INTERVENTION

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

Interventions

Inspiratory Muscle Training 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.

Also known as: Respiratory Muscle Training

Inspiratory muscle training

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

MeSH Terms

Conditions

Heart Diseases; Coronary Disease; Cardiovascular Diseases; Coronary Occlusion

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduation

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: January 12, 2010
• Primary Completion: March 17, 2011
• Study Completion: January 18, 2014
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share