Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

Not Applicable

• Conditions: Obstructive Sleep Apnea; Hypertension

• Registration Number: NCT03757169
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-12-17
• Status Verified: 2018-11
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change at ambulatory blood pressure monitoring	Change from the baseline ambulatory blood pressure monitoring at 12 weeks	24h of monitoring blood pressure

Secondary Outcome Measures

Name	Time	Method
Change at Pulse wave velocity	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.
Chance at Apnea-Hypopnea Index (AHI)	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 blood pressure	Change from the baseline brachial blood pressure at 12 weeks	Three measurement of brachial blood pressure

Trial Locations

Locations (1)

Pronto Socorro Cardiológico de Pernambuco - Procape; 🇧🇷 Recife, PE, Brazil