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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 27 May 2013
Main ID:  RBR-5d877q
Date of registration: 04/04/2012
Primary sponsor: Universidade Federal de São Carlos - São Carlos, SP, Brazil
Public title: Cardiac responses during rehabilitation in patients undergoing cardiac surgery
Scientific title: Study of cardiac autonomic modulation and pulmonary function in patients undergoing coronary artery bypass grafting and physiotherapy program: phase I of cardiac rehabilitation. - : Cardiac Autonomic Responses Exercise-Induced
Date of first enrolment: 01/06/2011
Target sample size: 44
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-5d877q/
Study type:  Intervention
Study design:  Therapeutic, parallel, with 2 arms, open, non randomized clinical trial.  
Countries of recruitment
Brazil
Contacts
Name: Renata  Mendes
Address:  Rodovia Washington Luís, km 235 - SP-310 13565-905 São Carlos Brazil
Telephone: 16-33518952
Email: mendesrg@hotmail.com
Affiliation:  Universidade Federal de São Carlos
Name: Renata  Mendes
Address:  Rodovia Washington Luís, km 235 - SP-310 13565-905 São Carlos Brazil
Telephone: 16-33518952
Email: mendesrg@hotmail.com
Affiliation:  Universidade Federal de São Carlos
Key inclusion & exclusion criteria
Inclusion criteria: Coronary artery disease (CAD)
Elective coronary artery bypass surgery (CABG) carried out with cardiopulmonary bypass (CPB).

Exclusion criteria: Patients who had undergone coronary artery bypass surgery (CABG) without cardiopulmonar bypass (CPB) or concomitant surgery;
History of myocardial infarction < 6 months before CABG, severely depressed LVF (left ventricular ejection fraction <30%), acute significant arrhythmias, coexisting chronic obstructive pulmonary disease (COPD), autonomic neuropathy, severe non-cardiac disease;
Inability or refuse to perform the proposed protocol.


Age minimum: 40Y
Age maximum: 80Y
Gender: -
Health Condition(s) or Problem(s) studied
patients undergoing coronary artery bypass surgery, exercise autonomic responses
I97.1
Intervention(s)
Postoperatively, the patients of LVF normal group (LVFN, n=23) and the patients of LVF reduced group (LVFR, n=21)followed the supervised once-daily physiotherapy program (in the afternoon) of early mobilization as described previously from first day after surgery (PO1) to hospital discharge (about 5 days). The program began with extremity range of moviment (ROM) exercises on PO1 and ambulation along hospital corridor from the third day post surgery (PO3), lasting 5 minutes progressing to 10 minutes for the subsequent days of hospitalization. Exercise intensity ranged between 2-4 METs and the heart rate (HR) during exercise did not exceed 20 bpm above HR rest.
In addition, the patients performed voluntary deep-breathing exercises from functional residual capacity to total lung capacity (40 deep breaths in four sets of 10, each breath included a 5 s hold at end inspiration) followed by coughs or huffs (with wound support) supervised once daily starting on PO1. Patients were instructed to perform these breathing and coughing exercises independently every waking hour.
Primary Outcome(s)
Reduced heart rate variability (HRV)indices during physical exercise in hospital, but the magnitude of autonomic response different between the groups with normal and reduced ventricular function, assessed by the nonlinear properties of heart rate variability (HRV), as the complexity (irregularity) of the dynamic process of heart rate were analyzed by indices such as: - correlation dimension (CD); Shannon entropy and sample entropy; and - Poincare indices: SD1 and SD2 interpreted as a measure of both short and long-term HRV (overall HRV.
Secondary Outcome(s)
Reduced heart rate variability (HRV)indices during physical exercise in hospital, but the magnitude of autonomic response different between the groups with normal and reduced ventricular function, assessed by the linear measures of HRV evaluated by calculating the following indices: - mean of RR and its standard deviation (STD RR), - integral of the RR histogram divided by the height of the histogram (RR tri) index and - baseline width of the RR histogram (TINN)and - square root of the mean squared differences of successive RR (rMSSD).

Secondary ID(s)
0095.0.135.000-05
197/2005
Source(s) of Monetary Support
Fundação de Amparo a pesquisa do estado de São Paulo - São Paulo, SP, Brazil
Secondary Sponsor(s)
Irmandade Santa Casa de Misericórdia de Araraquara - Araraquara, SP, Brazil
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