Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

NCT03757169 | Unknown

• 1 other identifier: isopress03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Hypertension

Keywords

training; hand grip; exercise

Outcome Measures

Primary Outcomes (1)

• Change at ambulatory blood pressure monitoring

  24h of monitoring blood pressure

  Change from the baseline ambulatory blood pressure monitoring at 12 weeks

Secondary Outcomes (3)

• Change at blood pressure

  Change from the baseline brachial blood pressure at 12 weeks

• Chance at Apnea-Hypopnea Index (AHI)

  Change from the baseline AHI at 12 weeks

• Change at Pulse wave velocity

  Change from the baseline pulse wave velocity at 12 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Control

Hand grip group

ACTIVE COMPARATOR

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

Interventions

Hand grip isometric contraction OTHER

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.

Hand grip group

Control OTHER

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

Control group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSA diagnose based on polysomnography,
• Apnea-Hypopnea Index (AHI) \> 5,
• arterial hypertension (systolic arterial pressure \> 140 mmHg or diastolic arterial pressure \> 90 mmHg)

You may not qualify if:

• other heart disease

Sponsors & Collaborators

• University of Pernambuco: lead

Study Sites (1)

Pronto Socorro Cardiológico de Pernambuco - Procape

Recife, Pernambuco, 50.100-060, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Flávio MD Andrade, Ms

CONTACT

+55 81 99635 5417; flaviomacielandrade@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of sleep laboratory and heart emergency room of Pernambuco , Principal Investigator.

Model Details: There are two randomized groups.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 28, 2018
• Study Start: December 17, 2017
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

BR (1)