NCT05179382

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

December 17, 2021

Last Update Submit

April 19, 2024

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Other: Hydration protocol

Interventions

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.

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. 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.

Hydration protocol

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Include healthy and male individuals, age between 18 and 25 years and physically active.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060900, Brazil

Location

Study Officials

  • Luiz Carlos M Vanderlei, PhD

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 5, 2022

Study Start

January 1, 2022

Primary Completion

May 8, 2022

Study Completion

July 6, 2022

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations