Effects of Exercise Training and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep

November 11, 2024 updated by: University of Sao Paulo General Hospital

Effects of Exercise Training on Neurovascular Control, Endothelial Function, Cognitive Functioning and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep

The objective is to investigate the effects of exercise training in hypertensive individuals with obstructive sleep apnea (OSA) in neurovascular control taking into account genetic factors. Seventy-two hypertensive patients with OSA >15 events/hour of sleep revealed by nocturnal polysomnography will be randomized into a control or physical training group. All will be evaluated for the T786 genotypes of the eNOS gene gene. The study will investigate the effect of the exercise program on vascular control in different alleles of the T786 genotypes of the eNOS gene.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Experimental Design. All participants underwent overnight polysomnography study. The apnea-hypopnea index (AHI) will be calculated by total number of respiratory events (apneas and hypopneas) per hour of sleep. Obstructive sleep apnea will be defined as a cessation of respiratory airflow for 10 seconds with thoracoabdominal effort, which was detected by Piezo respiratory effort sensor. Individuals with >70% of obstructive events were defined as individuals with OSA.

Muscle blood flow will be evaluated by pletismography tecnique.

Heart rate and blood pressure. Heart rate (HR) was beat-by-beat continuously measured during the test obtained in a computer-recorded electrocardiographic tracing. Blood pressure (BP) was monitored noninvasively from an automatic leg blood pressure cuff (nondominant leg) using automated oscillometric device. The systolic, diastolic and mean blood pressures will be registered.

Cardiopulmonary Exercise Test. Maximal exercise capacity was determined by means of a maximal progressive cardiopulmonary exercise test Peak VO2 will be defined as the maximum attained VO2 at the end of the exercise period in which the subject could no longer maintain the walk velocity.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04141001
        • Linda Massako Ueno Pardi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • sedentary,
  • Hipertensive patients

Exclusion Criteria:

  • Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OSA training group
The training group will be analised compared the effects of exercise on vascular function in different polimorphic aleles.
Other: Exercise training
Includes aerobic exercise, strength training, streching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic polymorphism and obstructive sleep apnea
Time Frame: 4 months of exercise training
To investigate the effect of exercise training on vascular, sleep parameters, and cognitive function in hypertensive with OSA in different genotypes of the endothelial nitric oxide synthase (eNOS) polymorphism (T786C).
4 months of exercise training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Linda M Ueno-Pardi, Phd, USP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

February 20, 2028

Study Completion (Estimated)

February 25, 2028

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5466/22/045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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