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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
Sponsor:
Information provided by (Responsible Party):
Rodrigo Pinto Pedrosa, University of Pernambuco

Brief Summary:
Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. A Meta analysis study have shown that isometric hand grip training promotes blood pressure reduction. It is going to be conducted a clinical trail to determine the effects of hand grip training in OSA patients to change the arterial hypertension.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Hypertension Other: Hand grip isometric contraction Other: Control Not Applicable

Detailed Description:
Background: obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. Meta analysis study have shown that isometric hand grip strength promotes blood pressure reduction, and its reduction is higher than that observed after aerobic training. Objective: to analyze the effects of the isometric hand grip on blood pressure changes of patients with uncontrolled arterial hypertension with OSA. Methods: a randomized controlled trial involving 18 adults with OSA and uncontrolled arterial hypertension of both sexes, randomized between control group (receive general guidelines) and hand grip group. 12 weeks of training with load equivalent to 30% of maximum voluntary capacity was performed. All participants will be submitted for evaluation of blood pressure (BP) central and brachial, pulse wave velocity, full polysomnography,before and after the study protocol (the change from the baseline at 12 weeks). Expected results: the authors believe that hand grip training can change (reduce) blood pressure in patient with OSA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are two randomized groups.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Sleep Apnea

Arm Intervention/treatment
Active Comparator: Control group
Verbal informations about the disease, and exercise behavior, and nutrition.
Other: Control
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.




Primary Outcome Measures :
  1. Change at ambulatory blood pressure monitoring [ Time Frame: Change from the baseline ambulatory blood pressure monitoring at 12 weeks ]
    24h of monitoring blood pressure


Secondary Outcome Measures :
  1. Change at blood pressure [ Time Frame: Change from the baseline brachial blood pressure at 12 weeks ]
    Three measurement of brachial blood pressure

  2. 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.

  3. 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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OSA diagnose based on polysomnography,
  • Apnea-Hypopnea Index (AHI) > 5,
  • arterial hypertension (systolic arterial pressure > 140 mmHg or diastolic arterial pressure > 90 mmHg)

Exclusion Criteria:

  • other heart disease

Information from the National Library of Medicine

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


Contacts
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Contact: Flávio MD Andrade, Ms +55 81 99635 5417 flaviomacielandrade@yahoo.com.br

Locations
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Brazil
Pronto Socorro Cardiológico de Pernambuco - Procape Recruiting
Recife, PE, Brazil, 50.100-060
Contact: Rodrigo Pedrosa, PhD    +55 81 31817179    rppedrosa@terra.com.br   
Contact: Flávio MD Andrade, Ms    + 55 81 99635 54 17      
Sponsors and Collaborators
University of Pernambuco
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Responsible Party: Rodrigo Pinto Pedrosa, Head of sleep laboratory and heart emergency room of Pernambuco , Principal Investigator., University of Pernambuco
ClinicalTrials.gov Identifier: NCT03757169    
Other Study ID Numbers: isopress03
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodrigo Pinto Pedrosa, University of Pernambuco:
training
hand grip
exercise
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases