Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

Hypertension Clinical Trial

— OSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03757169
• Other study ID #: isopress03
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2017
• Est. completion date: February 2019

Study information

• Verified date: November 2018
• Source: University of Pernambuco
• Contact: Flávio MD Andrade, Ms
• Phone: +55 81 99635 5417
• Email: flaviomacielandrade[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• Control
The patients will receive verbal orientations about the OSA and the arterial hypertension.

Locations

Country	Name	City	State
Brazil	Pronto Socorro Cardiológico de Pernambuco - Procape	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change at ambulatory blood pressure monitoring	24h of monitoring blood pressure	Change from the baseline ambulatory blood pressure monitoring at 12 weeks
Secondary	Change at blood pressure	Three measurement of brachial blood pressure	Change from the baseline brachial blood pressure at 12 weeks
Secondary	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
Secondary	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