Viewing Study NCT02437552



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Last Modification Date: 2024-10-26 @ 11:42 AM
Study NCT ID: NCT02437552
Status: WITHDRAWN
Last Update Posted: 2021-02-02
First Post: 2015-04-29

Brief Title: Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery
Sponsor: University of Sao Paulo
Organization: University of Sao Paulo

Study Overview

Official Title: Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery
Status: WITHDRAWN
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: This study would be conducted by a master course student nevertheless she was unable to go forward with it
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None