Exercise TrainingNCT06687863
Effects of Exercise Training and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep
A study testing Exercise training in people with Exercise Training and Genetic Polymorphism, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Exercise Training, Genetic Polymorphism
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Feb 2024to 25 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sedentary,
- Hipertensive patients
Who cannot join
- Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Includes aerobic exercise, strength training, streching
| Study group | Role | What they receive |
|---|---|---|
| OSA training group | Experimental | The training group will be analised compared the effects of exercise on vascular function in different polimorphic aleles. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start26 Feb 2024
- Primary completion20 Feb 2028 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda M Ueno-Pardi, Phd, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687863
- Sponsor's protocol ID
- 5466/22/045
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Neurovascular Control, Endothelial Function, Cognitive Functioning and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep
- ClinicalTrials.gov ID
- NCT06687863
- Acronym / sponsor ID
- 5466/22/045
- Conditions
- Exercise Training, Genetic Polymorphism
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 20 Feb 2028 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA training group | Experimental | Other: Exercise trainingThe training group will be analised compared the effects of exercise on vascular function in different polimorphic aleles. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sedentary,
- Hipertensive patients
Key exclusion criteria (1 listed)
- Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingIncludes aerobic exercise, strength training, streching | Other | OSA training group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda M Ueno-Pardi, Phd principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Exercise Training and Genetic Polymorphism, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic polymorphism and obstructive sleep apnea (time frame: 4 months of exercise training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.