HealthyNCT05179382
Integrated Analysis in Recovery After Exercise With and Without Hydration.
A study testing Hydration protocol in people with Healthy, run by Luiz Carlos Marques Vanderlei at 1 site in Brazil.
Trial summary
This study aims to evaluate post-exercise recovery in healthy young men submitted to a prolonged exercise protocol of submaximal intensity with or without water intake, from the integrated analysis of autonomic (heart rate variability indices), cardiovascular outcomes (systolic blood pressure, diastolic blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hydration protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2022to 6 Jul 2022
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Include healthy and male individuals, age between 18 and 25 years and physically active.
Who cannot join
- Volunteers with at least one of the following characteristics will be excluded: smoking, use of drugs that influence the autonomic activity of the heart, alcoholics, people with known metabolic and/or endocrine disorders, and sedentary individuals, insufficiently active and very active.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060900
About this study
Official title: Integrated Analysis of Autonomic, Cardiovascular and Respiratory Parameters in Recovery After Physical Exercise With and Without Water Ingestion: Crossover Non-randomized Clinical Test
This study aims to evaluate post-exercise recovery in healthy young men submitted to a prolonged exercise protocol of submaximal intensity with or without water intake, from the integrated analysis of autonomic (heart rate variability indices), cardiovascular outcomes (systolic blood pressure, diastolic blood pressure and heart rate) and respiratory (oxygen saturation and respiratory frequency). In addition, it will also be evaluated whether the proposed model is able to estimate the number of individuals undergoing hydration that have better recovery.
- Conditions
- Healthy
- Being tested
- Control protocol, Hydration protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control protocolOther
I.10 minutes of initial rest in the supine position; II. 90 minutes of treadmill aerobic exercise at an intensity of 60% of the vo2 peak; IV. 60 minutes of passive recovery in the supine position.
Hydration protocolOther
I.10 minutes of initial rest in the supine position; II. 90 minutes of treadmill aerobic exercise at an intensity of 60% of the vo2 peak; IV. 60 minutes of passive recovery in the supine position. V. Water ingestion distributed in 10 equal portions, administered at regular intervals of 15 minutes from the 15th minute of exercise until the end of the recovery period.
| 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: Control protocol |
| Hydration protocol | Experimental | This intervention 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: Hydration protocol |
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, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Measured: Acute evaluation during interventions
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, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Measured: Acute evaluation during interventions
Respiratory Rate
The measurements will be performed by counting the breaths for one minute without the volunteer being aware of the process, so that the usual breathing characteristics are not modified. Data will be collected at the end of the 10 minutes of initial rest as well as will be collected at minutes 1, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Measured: Acute evaluation during interventions
Peripheral oxygen saturation
Will be checked using a pulse oximeter. A pulse oximeter is a device that provides blood saturation readings, evaluating the absorption behavior of oxyhemoglobin and deoxyhemoglobin in relation to the lengths of red and infrared light. 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, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Measured: Acute evaluation during interventions
Autonomic Modulation - rMSSD 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 rMSSD index corresponds to the root-mean square of differences between adjacent normal RR intervals in a time interval, expressed in milliseconds.
Measured: Acute evaluation during interventions
Autonomic Modulation - SDNN 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 SDNN index corresponds to the standard deviation of all normal RR intervals recorded in a time interval, expressed in milliseconds.
Measured: Acute evaluation during interventions
Autonomic Modulation - LF 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 LF index is the low-frequency component of the oscillatory components of heart rate variability, and ranges from 0.04 to 0.15 Hz.
Measured: Acute evaluation during interventions
Autonomic Modulation - HF index
he 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 HF index is the high-frequency component of the oscillatory components of heart rate variability, and ranges from 0.15 to 0.4 Hz.
Measured: Acute evaluation during interventions
Autonomic Modulation - SD1 index
he 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: Acute evaluation during interventions
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: Acute evaluation during interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2022
- Primary completion8 May 2022
- Study completion6 Jul 2022
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luiz Carlos Marques Vanderlei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos M Vanderlei, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179382
- Sponsor's protocol ID
- 38152620500005402
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Analysis of Autonomic, Cardiovascular and Respiratory Parameters in Recovery After Physical Exercise With and Without Water Ingestion: Crossover Non-randomized Clinical Test
- ClinicalTrials.gov ID
- NCT05179382
- Acronym / sponsor ID
- 38152620500005402
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Luiz Carlos Marques VanderleiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 5 Jan 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.
This study aims to evaluate post-exercise recovery in healthy young men submitted to a prolonged exercise protocol of submaximal intensity with or without water intake, from the integrated analysis of autonomic (heart rate variability indices), cardiovascular outcomes (systolic blood pressure, diastolic blood pressure and heart rate) and respiratory (oxygen saturation and respiratory frequency). In addition, it will also be evaluated whether the proposed model is able to estimate the number of individuals undergoing hydration that have better recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control protocol | Active comparator | Other: Control protocolThe 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: Hydration protocolThis intervention 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 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Include healthy and male individuals, age between 18 and 25 years and physically active.
Key exclusion criteria (1 listed)
- Volunteers with at least one of the following characteristics will be excluded: smoking, use of drugs that influence the autonomic activity of the heart, alcoholics, people with known metabolic and/or endocrine disorders, and sedentary individuals, insufficiently active and very active.
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 |
|---|---|---|
| Control protocolI.10 minutes of initial rest in the supine position; II. 90 minutes of treadmill aerobic exercise at an intensity of 60% of the vo2 peak; IV. 60 minutes of passive recovery in the supine position. | Other | Control protocol |
| Hydration protocolI.10 minutes of initial rest in the supine position; II. 90 minutes of treadmill aerobic exercise at an intensity of 60% of the vo2 peak; IV. 60 minutes of passive recovery in the supine position. V. Water ingestion distributed in 10 equal portions, administered at regular intervals of 15 minutes from the 15th minute of exercise until the end of the recovery period. | Other | Hydration protocol |
Primary outcome
Blood Pressure
Time frame: Acute evaluation during interventions
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, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Heart Rate
Time frame: Acute evaluation during interventions
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, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Respiratory Rate
Time frame: Acute evaluation during interventions
The measurements will be performed by counting the breaths for one minute without the volunteer being aware of the process, so that the usual breathing characteristics are not modified. Data will be collected at the end of the 10 minutes of initial rest as well as will be collected at minutes 1, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Peripheral oxygen saturation
Time frame: Acute evaluation during interventions
Will be checked using a pulse oximeter. A pulse oximeter is a device that provides blood saturation readings, evaluating the absorption behavior of oxyhemoglobin and deoxyhemoglobin in relation to the lengths of red and infrared light. 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, 3, 5, 7, 10, 20, 30, 40, 50 and 60 of recovery.
Autonomic Modulation - rMSSD index
Time frame: Acute evaluation during interventions
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 rMSSD index corresponds to the root-mean square of differences between adjacent normal RR intervals in a time interval, expressed in milliseconds.
Autonomic Modulation - SDNN index
Time frame: Acute evaluation during interventions
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 SDNN index corresponds to the standard deviation of all normal RR intervals recorded in a time interval, expressed in milliseconds.
Autonomic Modulation - LF index
Time frame: Acute evaluation during interventions
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 LF index is the low-frequency component of the oscillatory components of heart rate variability, and ranges from 0.04 to 0.15 Hz.
Autonomic Modulation - HF index
Time frame: Acute evaluation during interventions
he 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 HF index is the high-frequency component of the oscillatory components of heart rate variability, and ranges from 0.15 to 0.4 Hz.
Autonomic Modulation - SD1 index
Time frame: Acute evaluation during interventions
he 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: Acute evaluation during interventions
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 22 Apr 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. This study is not recruiting at the moment.
Luiz Carlos M Vanderlei, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration protocol in people with Healthy, run by Luiz Carlos Marques Vanderlei 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 22 Apr 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?
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: Acute evaluation during interventions). The study lists 10 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 22 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.