Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery

Study Overview
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Brief Summary
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The prevalence of heart diseases has increased significantly in recent years and it is a health public problem due to an increased risk of death by several reasons. A cardiac surgery is an alternative of treatment for critical injuries heart valves and coronaries arteries. Changes in respiratory system resulting from cardiac surgery are well established and include a reduced functional capacity due post-surgical pain, causing increased respiratory function and increased oxygen consumption . The exercises with the cycle ergometer in phase I of cardiac rehabilitation can improve peripheral muscle strength, functional capacity and perception of dyspnea when used postoperatively and there are speculations if an earlier carried out can contribute to a better postoperative evolution of patients, but these benefits in phase I of the Rehabilitation Cardiac are not well defined in the literature. Objective: To evaluate the exercises effects with ergometer cycle in the postoperative course of patients undergoing cardiac surgery. Method: Patients will be recruited the cardiac surgery service of Polyclinic Pato Branco in the city of Pato Branco in state of Paraná, of both sexes, appropriate for the inclusion criteria, which will be evaluated by pulmonary function tests (strength of respiratory muscles, submaximal exercise test, dyspnea scales, laboratories tests and radiological exam). All patients will be randomly assigned for one of two groups: the control group (Conventional treatment) and rehabilitation group (conventional treatment +cycle ergometer), for about 7 days at postoperative period. Patients will be reevaluated on the third postoperative day and at discharge. Clinical evolution data will be collected from the records and notes of the medical staff and monitoring physiotherapist.

Detailed Description
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The research will be a randomized controlled clinical trial. The study will be conducted at the Polyclinic Pato Branco, in the city of Pato Branco Parana - Brazil and this study already approved by the Ethics Committee Clinical Hospital and Faculty of Medicine, University of São Paulo and all participants sign the consent form informed. For the implementation of research wil be recruited patients heart surgery who fit the inclusion criteria and do not show any characteristics of the exclusion criteria, which agree to participate and sign the consent form free and informed. The equipment and tests are already included in routine admissions of patients, approved by the hospital and the Brazilian Public Health System (SUS).

Official Title
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Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery

Conditions
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Exercise Movement Techniques, Cardiac Surgery

Intervention / Treatment
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* Device: ergometer cycle exercise
* Other: routine physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing cardiac surgery type Myocardial Revascularization and Exchange Mitral Valve Aortic, both sexes and aged between 30-75 years. Exclusion Criteria: Patients undergoing surgical correction of heart disease congenital, aortic aneurysm and dissection of aorta; Present disabling disease to accomplish what is proposed in study as previous stroke, mental or motor deficit, hearing loss, amputation of the lower limbs (unilateral or bilateral); Present psychomotor agitation of immediate postoperative and first postoperative and history weaning failure in the immediate; Instability hemodynamics and vasoactive drugs; Present what other type of peri and postoperative complications; Re-operation within 24 hrs.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group: routine physiotherapy<br>Are patients who carry out the routine already established the Unit, consisting of the first post surgery, the patient lying down doing the breathing exercises, active exercises ends and active-assisted upper (UL) and lower limbs (LL), | Other: routine physiotherapy<br>* routine physiotherapy<br>|
| Active Comparator: Intervention group: ergometer cycle exercise<br>Are the patients who will carry out the exercises routine over the cycle ergometer twice daily from 3 PO for 5 minutes with its progressiveness at discharge for ward for 10 minutes | Device: ergometer cycle exercise<br> <br> Other: routine physiotherapy<br>* routine physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of six-minute walk test (6MMWT) distance | The six-minute walk test will be conducted with monitoring blood pressure, HR, RR and SpO2 in a hall plan, with distances previously marked. The patient will be accompanied by the researcher and encouraged by constant verbal stimulation, walking as fast as possible, if the patient stop walking the timer will keep triggered. Will use the oximeter with the sensor on the third finger of the right hand, and a certain reading after the signal stabilization and at the same time we get the heart rate. Will be used to calculate the expected value, and reference to distance in the 6MWT, the equations proposed by Enright and Sherrill (1998) determining the percentage of predicted for each test performed by patient. | Before surgery ,third and seventh postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of spirometric values | Spirometry will be performed according to criteria of the American Thoracic Society and the Brazilian Consensus Spirometry. Values will be observed from CVF, VEF1 e PEF. | Before surgery ,third and seventh postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Coronary Artery Bypass, Exercise Movement Techniques