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

Cardiovascular Diseases Clinical Trial

Official title:

Effects of Inspiratory Muscle Training Hihg Intensity Linked to Cardiac Rehabilitation in Patients on Exercise Performance in the Post-operative of Coronary Artery Bypasssurgery: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742350
• Other study ID #: IMT+exercise-CABG
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: April 27, 2017
• Start date: September 10, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: April 2017
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

It is a controlled, randomized clinical trial in which patients were randomly assigned randomly after referral to cardiac rehabilitation: Group 1 IMT-HI, group 2 - IMT-HI control. The evaluator of outcomes is blinded as to groups. The study protocol lasts 36 sessions for both groups. The group 1 patients performs cardiac rehabilitation protocol for 40 minutes with cardio and stretching and also inspiratory muscle training protocol of high intensity with 50% load increase in maximal inspiratory pressure during the first two weeks, 60% of MIP in third and fourth week, 70% of MIP in the fifth and sixth week and 80% MIP in the seventh and eighth week. The group 2 patients only perform the cardiac rehabilitation protocol for 40 minutes with aerobic exercise and stretching.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients in the postoperative period of elective CABG

• Between the fourteenth and the thirtieth day after surgery

• Between 30 and 70 years old

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Rodrigo Della Méa Plentz	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-s chair-stand	With the patient sitting in a chair with 45cm tall, with your feet apart and flat on the floor and arms crossed against his chest, the patient will be encouraged to get up and return to a sitting position as many times as possible in 30 seconds, It is registered the maximum number of repetitions.	1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week
Secondary	respiratory muscle strength test		1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week
Secondary	Quality of life	Brazilian version of the Quality of Life Questionnaire - SF-36	1 week, through study completion, an average of 12 week