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

Primary Purpose

Obstructive Sleep Apnea, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hand grip isometric contraction
Control
Sponsored by
University of Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring training, hand grip, exercise

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pronto Socorro Cardiológico de Pernambuco - ProcapeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Hand grip group

Arm Description

Verbal informations about the disease, and exercise behavior, and nutrition.

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.

Outcomes

Primary Outcome Measures

Change at ambulatory blood pressure monitoring
24h of monitoring blood pressure

Secondary Outcome Measures

Change at blood pressure
Three measurement of brachial blood pressure
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 at Pulse wave velocity
To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease.

Full Information

First Posted
November 21, 2018
Last Updated
November 28, 2018
Sponsor
University of Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT03757169
Brief Title
Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)
Acronym
OSA
Official Title
Effect of Isometric Hand Grip Training on Blood Pressure of Hypertensive Patients With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypertension
Keywords
training, hand grip, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two randomized groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Verbal informations about the disease, and exercise behavior, and nutrition.
Arm Title
Hand grip group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hand grip isometric contraction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The patients will receive verbal orientations about the OSA and the arterial hypertension.
Primary Outcome Measure Information:
Title
Change at ambulatory blood pressure monitoring
Description
24h of monitoring blood pressure
Time Frame
Change from the baseline ambulatory blood pressure monitoring at 12 weeks
Secondary Outcome Measure Information:
Title
Change at blood pressure
Description
Three measurement of brachial blood pressure
Time Frame
Change from the baseline brachial blood pressure at 12 weeks
Title
Chance at Apnea-Hypopnea Index (AHI)
Description
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.
Time Frame
Change from the baseline AHI at 12 weeks
Title
Change at Pulse wave velocity
Description
To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease.
Time Frame
Change from the baseline pulse wave velocity at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flávio MD Andrade, Ms
Phone
+55 81 99635 5417
Email
flaviomacielandrade@yahoo.com.br
Facility Information:
Facility Name
Pronto Socorro Cardiológico de Pernambuco - Procape
City
Recife
State/Province
PE
ZIP/Postal Code
50.100-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Pedrosa, PhD
Phone
+55 81 31817179
Email
rppedrosa@terra.com.br
First Name & Middle Initial & Last Name & Degree
Flávio MD Andrade, Ms
Phone
+ 55 81 99635 54 17

12. IPD Sharing Statement

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Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

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