Clinical trial NCT02742350: Effects of Muscle Trainins Inspiratory Linked to Cardiac Rehabilitation Post-operative of CABG Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Six-minute walk test
timeFrame: 1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week
Secondary outcomes:
measure: 30-s chair-stand
timeFrame: 1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week
measure: respiratory muscle strength test
timeFrame: 1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week
measure: Quality of life
timeFrame: 1 week, through study completion, an average of 12 week
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Rodrigo Della Méa Plentz
state: RS
Study officials:
References: