- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05179382
Integrated Analysis in Recovery After Exercise With and Without Hydration.
April 19, 2024 updated by: Luiz Carlos Marques Vanderlei
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brazil, 19060900
- Universidade Estadual Paulista Júlio de Mesquita Filho
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Include healthy and male individuals, age between 18 and 25 years and physically active.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control protocol
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.
|
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.
|
Experimental: Hydration protocol
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
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.
|
Acute evaluation during interventions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Luiz Carlos M Vanderlei, PhD, Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
May 8, 2022
Study Completion (Actual)
July 6, 2022
Study Registration Dates
First Submitted
December 17, 2021
First Submitted That Met QC Criteria
December 17, 2021
First Posted (Actual)
January 5, 2022
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 38152620500005402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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