Clinical trial NCT02437552: Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery
Official title: Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise Movement Techniques
Cardiac Surgery
Keywords: Cardiac Surgery, Coronary Artery Bypass, Exercise Movement Techniques
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 0
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: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change of six-minute walk test (6MMWT) distance
timeFrame: Before surgery ,third and seventh postoperative day
Secondary outcomes:
measure: Change of spirometric values
timeFrame: Before surgery ,third and seventh postoperative day
Other outcomes:
measure: Change of respiratory muscle strength - Mouth pressure measurements
timeFrame: Before surgery ,third and seventh postoperative day
measure: Change of perceived dyspnea
timeFrame: Before surgery ,third and seventh postoperative day
measure: Change of body mass index
timeFrame: Before surgery and postoperative seventh day
measure: Change of cirtometry
timeFrame: Before surgery ,third and seventh posoperative day
measure: Change of peripheral muscle strength
timeFrame: Before surgery ,third and seventh postoperative day
measure: Change in cortisol levels
timeFrame: Before surgery ,third and seventh postoperative day
measure: change of radiological assessment
timeFrame: Before surgery ,third and seventh postoperative day
measure: Adherence evaluation
timeFrame: Third and seventh postoperative day
Locations:
city: Pato Branco
country: Brazil
facility: Policlínica Pato Branco
state: Paraná
Study officials:
References:
citation: BAUMGARTEN, M.C.S. et al. Behavior of pain and pulmonary function in patients undergoing heart surgery via sternotomy. Rev Bras-surgical Cardiovasc.24 (4), 2009 BRUMMEL, N.S; GIRARD, T.D. Preventing delirium in the intensive care unit.Crit Care Clin. 29(1):51-65 , 2013. Guidelines on Cardiopulmonary and Metabolic Rehabilitation: Practical Aspects and Responsibilities. Arq Bras Cardiol of. V. 86, No. 1, January 2006. Available in http://publicacoes.cardiol.br/consenso/2006/8601012.pdf> access 10/14/14, 13h22min. ENRIGHT IP SHERRIL DI. Reference equations for the six minute walk in healthy adults. Am J Respir Crit Care Med. V.158, p.1384-1387,1998.