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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. |
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Register:
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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-386qsg |
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Date of registration:
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09/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Influence of positive airway pressure in the range of reduced pressure after exercise in hypertensive Patients with Obstructive Sleep Apnea
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Scientific title:
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Influence of positive airway pressure in the magnitude post-exercise hipotension in hypertensive patients with obstructive sleep apnea |
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Date of first enrolment:
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05/01/2014 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-386qsg |
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Study type:
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Intervention |
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Study design:
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Clinical efficacy trial, open, single 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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José Heriston
Morais Lima |
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Address:
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Av. Sérgio Guerra, 465, apt. 305, Ed. Angélica, Bancários
58052-000
João Pessoa
Brazil |
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Telephone:
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+55(83)99947332 |
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Email:
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joseheristonlima@yahoo.com.br |
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Affiliation:
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UFPB |
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Name:
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José Heriston
Morais Lima |
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Address:
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Av. Sérgio Guerra, 465, apt. 305, Ed. Angélica, Bancários
58052-000
João Pessoa
Brazil |
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Telephone:
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+55(83)99947332 |
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Email:
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joseheristonlima@yahoo.com.br |
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Affiliation:
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UFPB |
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Key inclusion & exclusion criteria
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Inclusion criteria: Sleep Apnea diagnosis, both genders, is between stage 1 and stage 3 hypertension; Being classified as Insufficiently active by Physical Activity Questionnaire; present classification in moderate to severe polysomnography; owning between 20 and 80 years, no history of previous lung disease, not present muscle damage, joint or bone that may compromise the partial or complete execution of any proposed exercise
Exclusion criteria: Be classified as active in international physical activity questionnaire; presence of chronic lung disease.
Age minimum:
20Y
Age maximum:
80Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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C14.907.489
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C08.618.085.852.850
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Obstructive Sleep Apnea Syndrome, Hypertension
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Intervention(s)
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Other
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E02.041.625.790.259
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G11.427.590.530.698.277
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The study will be conducted with 30 patients with hypertension and obstructive sleep apnea where everyone will receive the same treatment and be evaluated before and after the intervention.
Patients carry out assessment of respiratory muscle strength (maximum inspiratory pressure and maximal expiratory pressure); peak expiratory flow; Epworth sleepiness scale.
After initial evaluation, patients will perform 40 minutes of aerobic exercise on a stationary bike, then put the exercise ambulatory blood pressure-MAP.
After 24 hours the MAP will be removed and the patient instructed to sleep 5 days with continuous positive airway pressure - CPAP. Upon completion day the patient repeat the initial assessment, aerobic exercise and placing the MAP.
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Primary Outcome(s)
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Decreased systolic and diastolic blood pressure by ambulatory blood pressure monitoring (ABPM) at baseline and end of study, before and after intervention, considering variation of at least 5%
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Secondary Outcome(s)
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Improvement in sleep quality assessed by the Epworth Sleepiness Scale; improvement in nocturnal blood pressure by ABPM (> 10% and <20%)
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Source(s) of Monetary Support
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José Heriston de Morais LIma
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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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