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Enrolling by Invitation

NCT Number: NCT06687863

Effects of Exercise Training 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.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linda Massako Ueno Pardi

São Paulo, 04141001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • sedentary,
  • Hipertensive patients

Exclusion criteria

  • Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease

Treatment and study plan

Exercise training

Other

Includes aerobic exercise, strength training, streching

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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