Integrated Analysis in Recovery After Exercise With and Without Hydration.

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179382
• Other study ID #: 38152620500005402
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 6, 2022

Study information

• Verified date: July 2022
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 6, 2022
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Control 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.
• Hydration 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. 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.

Locations

Country	Name	City	State
Brazil	Universidade Estadual Paulista Júlio de Mesquita Filho	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Luiz Carlos Marques Vanderlei

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions
Primary	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.	Acute evaluation during interventions