Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA) (OSA)
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|ClinicalTrials.gov Identifier: NCT03757169|
Recruitment Status : Unknown
Verified November 2018 by Rodrigo Pinto Pedrosa, University of Pernambuco.
Recruitment status was: Recruiting
First Posted : November 28, 2018
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Hypertension||Other: Hand grip isometric contraction Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||There are two randomized groups.|
|Masking:||None (Open Label)|
|Official Title:||Effect of Isometric Hand Grip Training on Blood Pressure of Hypertensive Patients With Obstructive Sleep Apnea|
|Actual Study Start Date :||December 17, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Active Comparator: Control group
Verbal informations about the disease, and exercise behavior, and nutrition.
The patients will receive verbal orientations about the OSA and the arterial hypertension.
Active Comparator: Hand grip group
Three supervised sessions por week: 4 series (2 at each arm) of two minutes of isometric hand grip contraction at 30% of maximal voluntary contraction. Between series there will be two minutes to rest.
Other: Hand grip isometric contraction
The patients at the Hand Grip group will perform 12 weeks of hand grip exercises, three times/week for 16 minutes with time to rest.
- Change at ambulatory blood pressure monitoring [ Time Frame: Change from the baseline ambulatory blood pressure monitoring at 12 weeks ]24h of monitoring blood pressure
- Change at blood pressure [ Time Frame: Change from the baseline brachial blood pressure at 12 weeks ]Three measurement of brachial blood pressure
- Chance at Apnea-Hypopnea Index (AHI) [ Time Frame: Change from the baseline AHI at 12 weeks ]Index obtained by the Polysomnography to detect the level of Apnea-Hypopnea Index. The higher level, the worse the disease. The value of the AHI between 5 to 15 events/hour means mild disease. AHI between 16 to 30 events/hour means moderate disease, and more than 30 events/hour means severe disease.
- Change at Pulse wave velocity [ Time Frame: Change from the baseline pulse wave velocity at 12 weeks ]To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757169
|Contact: Flávio MD Andrade, Ms||+55 81 99635 firstname.lastname@example.org|
|Pronto Socorro Cardiológico de Pernambuco - Procape||Recruiting|
|Recife, PE, Brazil, 50.100-060|
|Contact: Rodrigo Pedrosa, PhD +55 81 31817179 email@example.com|
|Contact: Flávio MD Andrade, Ms + 55 81 99635 54 17|