Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA) (OSA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obstructive Sleep Apnea
• Intervention / Treatment: Other: Control; Other: Hand grip isometric contraction

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 Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PE
    • Recife, PE, Brazil, 50.100-060
      • Recruiting
      • Pronto Socorro Cardiológico de Pernambuco - Procape
      • Contact: Rodrigo Pedrosa, PhD; Phone Number: +55 81 31817179; Email: rppedrosa@terra.com.br
      • Contact: Flávio MD Andrade, Ms; Phone Number: + 55 81 99635 54 17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: exercise; training; hand grip
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: isopress03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No