Effects of Muscle Trainins Inspiratory Linked to Cardiac Rehabilitation Post-operative of CABG Surgery

NCT02742350 | Completed

• 1 other identifier: IMT+exercise-CABG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Heart surgery procedures are still widely used worldwide for the treatment of patients with heart problems, and rates of complications in the postoperative period related to them remain high. In these patients, physical conditioning programs result in improved functional capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle training is also emerging as a valuable strategy in the treatment of cardiac patients. The study of the interaction between cardiac rehabilitation and high intensity IMT about these changes is not yet understood in this population. The aim of this study is to assess the effects of inspiratory muscle training high intensity associated with cardiac rehabilitation exercise performance of patients in the postoperative period of CABG surgery.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test

  The patient is set to walk in a corridor of 30 meters delimited cones for six minutes in order to go as far as possible. Every minute the patient is stimulated by the evaluator.

  1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week

Secondary Outcomes (3)

• 30-s chair-stand

  1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week

• respiratory muscle strength test

  1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week

• Quality of life

  1 week, through study completion, an average of 12 week

Study Arms (2)

IMT+Exercise

EXPERIMENTAL

The inspiratory muscle training protocol (IMT) high intensity is achieved with a device with linear load pressure (POWERbreathe Plus Light Resistance®, SP, BR) that allows loads up to -90cmH2O. IMT is performed for 36 sessions (12 weeks) with weekly frequency of three times a week under supervision prior to the cardiac rehabilitation. The training protocol consists of five series with 10 repetitions each set until the 8th week with increase in the number of sets of repetitions of the 8th to 12th week, with two minutes or according to patient feedback using the modified Borg scale . Aerobic training lasts 40 minutes (5 minutes heating 30 minute workout and 5 minutes desaqueciemento. During training vital signs such as heart rate, blood pressure (BP) and peripheral oxygen saturation (SpO2) are evaluated and the feeling of effort the patient should not exceed the level of 8 according to the modified Borg scale.

Device: IMT - POWERbreathe Plus Light Resistance®, SP, BR

Exercise Control

NO INTERVENTION

Aerobic Exercise and Stretching

Interventions

IMT - POWERbreathe Plus Light Resistance®, SP, BR DEVICE

POWERbreathe Plus Light Resistance®, SP, BR

IMT+Exercise

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the postoperative period of elective CABG
• Between the fourteenth and the thirtieth day after surgery
• Between 30 and 70 years old

You may not qualify if:

• Decompensated heart failure
• Unstable angina
• Moderate respiratory disease severe
• Active infectious disease or fever
• Disabling peripheral vascular disease
• Unstable ventricular arrhythmias
• Use of cardiac pacemaker.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, 90130051, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: April 19, 2016
• Study Start: September 10, 2015
• Primary Completion: September 30, 2016
• Study Completion: December 30, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)