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

NCT ID: NCT06687863

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2028-02-25

Brief Summary

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.

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.

Conditions

Exercise Training; Genetic Polymorphism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

OSA training group

The training group will be analised compared the effects of exercise on vascular function in different polimorphic aleles.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: OTHER

Includes aerobic exercise, strength training, streching

Interventions

Exercise training

Includes aerobic exercise, strength training, streching

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• sedentary,
• Hipertensive patients

Exclusion Criteria

• Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda M Ueno-Pardi, Phd

Role: PRINCIPAL_INVESTIGATOR

USP

Locations

Linda Massako Ueno Pardi

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

5466/22/045

Identifier Type: -

Identifier Source: org_study_id