Main
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Note: This record shows only 22 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:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-8swgc3 |
Date of registration:
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13/06/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Inspiratory Mucle Training in Patients after Cardiac Surgery.
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Scientific title:
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Inspiratory Muscle Training in Patients Undergoing Cardiac Surgery. - : |
Date of first enrolment:
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05/06/2016 |
Target sample size:
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Recruitment status: |
Data analysis completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-8swgc3 |
Study type:
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Intervention |
Study design:
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Clinical trial of randomized-controlled treatment, parallel, open, with two arm.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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João Vyctor Silva
Fortes |
Address:
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Rua Barão de Itapari, 227 - Centro.
65020-070
São Luís
Brazil |
Telephone:
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+55 (98) 2109-2100 |
Email:
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vyctorfortes@yahoo.com.br |
Affiliation:
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Hospital Universitário da Universidade Federal do Maranhão |
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Name:
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João Vyctor Silva
Fortes |
Address:
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Rua Barão de Itapari, 227 - Centro.
65020-070
São Luís
Brazil |
Telephone:
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+55 (98) 2109-2100 |
Email:
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vyctorfortes@yahoo.com.br |
Affiliation:
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Hospital Universitário da Universidade Federal do Maranhão |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients undergoing cardiac surgery; Both genes; Age between 18 and 80.
Exclusion criteria: Evolved Death in the peri-operative period;
Evolved With pulmonary complications Or neurological factors that impeded the avaliation; They needed prolonged mechanical ventilation (> 24 hours); They needed Non-invasive mechanical ventilation for more than 4 hours per day.
Age minimum:
18Y
Age maximum:
80Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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E07.695.310
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I08.8
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Atherosclerotic cardiovascular disease; Myocardial infarction; Other multiple valve diseases; Valvular prostheses; Other functional disorders subsequent to cardiac surgery; Cardiac surgical procedures; Other pulmonary disorders; Pulmonary atelectasis.
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I97.1
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J98.4
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C08.381.730
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I25.0
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C14.280.647.500
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E04.100.376
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Intervention(s)
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Intervention group: 15 patients who underwent heart surgery, both valvular and myocardial revascularization, on the first postoperative day began inspiratory muscle training, using the Powerbreathe K5® , device using 30% of the load previously evaluated. While they were in the Intensive Care Unit (ICU), two training sessions were held, one in the morning shift and one in the afternoon shift. When they were discharged to the ward, training was performed only once a day. On the sixth postoperative day, the reevaluation was performed for comparison of respiratory muscle strength, lung function, functional capacity, and peripheral muscle strength, with preoperative evaluation. Control Group: 15 patients who underwent heart surgery, both valvular and myocardial revascularization, Received conventional physiotherapeutic care while they were in the ICU, twice a day, morning shift and afternoon shift,When they were discharged to the infirmary, the attendance was only once a day. On the sixth postoperative day, the reevaluation was performed to compare the respiratory muscle strength, lung function, functional capacity, peripheral muscle strength, with preoperative evaluation.
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E02.190.525.186
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Device
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G09.772
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Other
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Primary Outcome(s)
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Expected 2
Maintenance of peripheral muscle strength after six days of training. Verified using the handheld hydraulic dynamometer. From a variation of at least 5% in the measurements performed in the preoperative and sixth postoperative day.
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Found 1
There was reduction of pulmonary function Verified by spirometry Presented a value <0.0001 in the evaluation between the preoperative and the sixth postoperative day.
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Found 2
There was reduction of peripheral muscle strength after six days of training. Verified using the handheld hydraulic dynamometer. With a value de 0,02 in the measurements performed in the preoperative and sixth postoperative day.
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Expected 3
Maintenance of functional capacity, after six days of training. Checked using the Time Up and Go (TUG) test. From a variation of at least 5% in the preoperative and the sixth postoperative day.
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Expected 4
Recovery of inspiratory muscle strength after six days of training. Verified using the digital manovacuometer. From a variation of at least 5% in the preoperative and sixth postoperative day.
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Found 3
There was a reduction in functional capacity after six days of training. Checked using the Time Up and Go (TUG) test. Presented a value of 0,007 in the evaluations in the preoperative and sixth postoperative day.
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Expected 1
Recovery of lung function Verified by spirometry From a variation of at least 5% verified in the preoperative and on the sixth postoperative day.
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Found 5
There was a reduction in functional capacity after six days of training. Verified by functional independence measure scale (MIF). Presented value of 0,002 in the measurements performed in the preoperative and sixth postoperative day
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Found 4
There was maintenance of inspiratory muscle strength after six days of training. Verified using the digital manovacuometer. Present value of 0,11 in the evaluations performed in the preoperative and sixth postoperative day.
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Expected 5
Recovery of functional capacity after six days of training. Verified by functional independence measure scale (MIF). From a variation of at least 5% in the measurements performed in the preoperative and sixth postoperative days
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Secondary Outcome(s)
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No secondary outcomes were observed During the survey.
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Source(s) of Monetary Support
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Hospital Universitário da Universidade Federal do Maranhão
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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