HealthyNCT05231434
Influence of Hydration and Functional Aerobic Capacity on the Nonlinear Dynamics of Heart Rate in Healthy Individuals
A study testing water and aerobic activity in people with Healthy, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The objective of this study is to analyze the influence of hydration and functional aerobic capacity in young and healthy individuals on non-linear heart rate dynamics as a technique that favor faster and more efficient recovery cardiac autonomic modulation. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- water and aerobic activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jun 2020to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- include healthy and male individuals, age between 18 and 30 years and physically active.
Who cannot join
- individuals who smoke and drink, those who have infections, metabolic and respiratory diseases that may interfere in the results and orthopedic problems.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060-300
About this study
Official title: Influence of Hydration and Functional Capacity on the Recovery of Nonlinear Heart Rate Dynamics in Healthy Individuals: Crossover Clinical Trial
The objective of this study is to analyze the influence of hydration and functional aerobic capacity in young and healthy individuals on non-linear heart rate dynamics as a technique that favor faster and more efficient recovery cardiac autonomic modulation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterOther
hydration with mineral water in 10 equal portions, administered at regular intervals from the 15th minute of exercise until the end of the recovery period.
aerobic activityOther
aerobic activity
| Study group | Role | What they receive |
|---|---|---|
| Control protocol | Active comparator | The control protocol will consist of an initial 10 minutes of rest, followed by 90 minutes of aerobic activity and 60 minutes of the final recovery. Hydration will not be allowed throughout the protocol Receives: Other: aerobic activity |
| Hydration protocol | Experimental | The control protocol will consist of an initial 10 minutes of rest, followed by 90 minutes of aerobic activity and 60 minutes of the final recovery. In this protocol, volunteers will be hydrated with mineral water from the 15th minute of exercise until the end of recovery Receives: Other: water; Other: aerobic activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Will occur indirectly, using a stethoscope and an aneroid sphygmomanometer in the left arm. The indicated values will be registered in an individual form. To avoid errors in the determination of blood pressures in volunteers, a single evaluator will measure these variables throughout the experimental procedure. Data will be collected at the end of the 10 minutes of initial rest and at minutes 30, 60 and 90 during exercise on the treadmill, as well as will be collected at minutes 1, 5, 10, 20, 30, 40, 50 and 60 of recovery.
Measured: up to 3 weeks
Heart Rate
The heart rate will be captured beat by beat using the Polar RS800CX frequency meter, equipment previously validated to capture this parameter. Data will be collected at the end of the 10 minutes of initial rest and at minutes 30, 60 and 90 during exercise on the treadmill, as well as will be collected at minutes 1, 5, 10, 20, 30, 40, 50 and 60 of recovery.
Measured: up to 3 weeks
Autonomic Modulation - SD1 index
the data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. The SD1 index corresponds to the dispersion of points perpendicular to the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Measured: up to 3 weeks
Autonomic Modulation - SD2 index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. The SD2 index corresponds to the dispersion of points along the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start15 Jun 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- thamyres rangel R barros, Principal investigator, Universidade Estadual Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231434
- Sponsor's protocol ID
- 38152620.5.0000.5402
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hydration and Functional Capacity on the Recovery of Nonlinear Heart Rate Dynamics in Healthy Individuals: Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05231434
- Acronym / sponsor ID
- 38152620.5.0000.5402
- Conditions
- Healthy
- Keywords
- exercise, hydration, non-linear dynamic, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 9 Feb 2022 (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 of this study is to analyze the influence of hydration and functional aerobic capacity in young and healthy individuals on non-linear heart rate dynamics as a technique that favor faster and more efficient recovery cardiac autonomic modulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control protocol | Active comparator | Other: aerobic activityThe control protocol will consist of an initial 10 minutes of rest, followed by 90 minutes of aerobic activity and 60 minutes of the final recovery. Hydration will not be allowed throughout the protocol |
| Hydration protocol | Experimental | Other: water, Other: aerobic activityThe control protocol will consist of an initial 10 minutes of rest, followed by 90 minutes of aerobic activity and 60 minutes of the final recovery. In this protocol, volunteers will be hydrated with mineral water from the 15th minute of exercise until the end of recovery |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- include healthy and male individuals, age between 18 and 30 years and physically active.
Key exclusion criteria (1 listed)
- individuals who smoke and drink, those who have infections, metabolic and respiratory diseases that may interfere in the results and orthopedic problems.
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 |
|---|---|---|
| waterhydration with mineral water in 10 equal portions, administered at regular intervals from the 15th minute of exercise until the end of the recovery period. | Other | Hydration protocol |
| aerobic activityaerobic activity | Other | Control protocol, Hydration protocol |
Primary outcome
Blood Pressure
Time frame: up to 3 weeks
Will occur indirectly, using a stethoscope and an aneroid sphygmomanometer in the left arm. The indicated values will be registered in an individual form. To avoid errors in the determination of blood pressures in volunteers, a single evaluator will measure these variables throughout the experimental procedure. Data will be collected at the end of the 10 minutes of initial rest and at minutes 30, 60 and 90 during exercise on the treadmill, as well as will be collected at minutes 1, 5, 10, 20, 30, 40, 50 and 60 of recovery.
Heart Rate
Time frame: up to 3 weeks
The heart rate will be captured beat by beat using the Polar RS800CX frequency meter, equipment previously validated to capture this parameter. Data will be collected at the end of the 10 minutes of initial rest and at minutes 30, 60 and 90 during exercise on the treadmill, as well as will be collected at minutes 1, 5, 10, 20, 30, 40, 50 and 60 of recovery.
Autonomic Modulation - SD1 index
Time frame: up to 3 weeks
the data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. The SD1 index corresponds to the dispersion of points perpendicular to the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Autonomic Modulation - SD2 index
Time frame: up to 3 weeks
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. The SD2 index corresponds to the dispersion of points along the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
thamyres rangel R barros principal investigator
Universidade Estadual Júlio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water and aerobic activity in people with Healthy, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 1 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: finished, as of the sponsor's last update on 9 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure (time frame: up to 3 weeks). The study lists 4 primary outcomes in all. 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 9 Feb 2022.