Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Isometric Hand Grip Training on Blood Pressure of Hypertensive Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea, Hypertension

Intervention / Treatment
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* Other: Hand grip isometric contraction
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two randomized groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Verbal informations about the disease, and exercise behavior, and nutrition. | Other: Control<br>* The patients will receive verbal orientations about the OSA and the arterial hypertension.<br>|
| Active Comparator: Hand grip group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change at ambulatory blood pressure monitoring | 24h of monitoring blood pressure | Change from the baseline ambulatory blood pressure monitoring at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change at blood pressure | Three measurement of brachial blood pressure | Change from the baseline brachial blood pressure at 12 weeks | 
| Chance at Apnea-Hypopnea Index (AHI) | 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 from the baseline AHI at 12 weeks | 
| Change at Pulse wave velocity | To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease. | Change from the baseline pulse wave velocity at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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training, hand grip, exercise