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

NCT02437552 | Withdrawn DMC

• 1 other identifier: USP 2015-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Movement Techniques; Cardiac Surgery

Keywords

Cardiac Surgery, Coronary Artery Bypass, Exercise Movement Techniques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of spirometric values

  Before surgery ,third and seventh postoperative day

Other Outcomes (8)

• Change of respiratory muscle strength - Mouth pressure measurements

  Before surgery ,third and seventh postoperative day

• Change of perceived dyspnea

  Before surgery ,third and seventh postoperative day

• Change of body mass index

  Before surgery and postoperative seventh day

Study Arms (2)

Control group: routine physiotherapy

PLACEBO COMPARATOR

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

Intervention group: ergometer cycle exercise

ACTIVE COMPARATOR

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; Other: routine physiotherapy

Interventions

ergometer cycle exercise DEVICE

Intervention group: ergometer cycle exercise

routine physiotherapy OTHER

routine physiotherapy

Control group: routine physiotherapy; Intervention group: ergometer cycle 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 undergoing cardiac surgery type Myocardial Revascularization and Exchange Mitral Valve Aortic, both sexes and aged between 30-75 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Policlínica Pato Branco

Pato Branco, Paraná, 85501250, Brazil

Location

Related Publications (1)

• 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.

  RESULT

Study Design

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

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 7, 2015
• Primary Completion: January 28, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

BR (1)