NCT06687863

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Feb 2024Feb 2028

Study Start

First participant enrolled

February 26, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2028

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2028

Last Updated

November 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

February 27, 2024

Last Update Submit

November 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Genetic polymorphism and obstructive sleep apnea

    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

Study Arms (1)

OSA training group

EXPERIMENTAL

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

Other: Exercise training

Interventions

Includes aerobic exercise, strength training, streching

OSA training group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sedentary,
  • Hipertensive patients

You may not qualify if:

  • Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linda Massako Ueno Pardi

São Paulo, São Paulo, 04141001, Brazil

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Linda M Ueno-Pardi, Phd

    USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Data analysis will be carried out by evaluators who do not know the allele of the participant's genetic polymorphism
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

November 14, 2024

Study Start

February 26, 2024

Primary Completion (Estimated)

February 20, 2028

Study Completion (Estimated)

February 25, 2028

Last Updated

November 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations