NCT05231434

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2020

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

Study Start

First participant enrolled

June 15, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

January 5, 2022

Last Update Submit

January 28, 2022

Conditions

Keywords

exercisehydrationnon-linear dynamicAutonomic nervous system

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    up to 3 weeks

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: 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

Other: waterOther: aerobic activity

Interventions

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.

Hydration protocol

aerobic activity

Control protocolHydration protocol

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • include healthy and male individuals, age between 18 and 30 years and physically active.

You may not qualify if:

  • individuals who smoke and drink, those who have infections, metabolic and respiratory diseases that may interfere in the results and orthopedic problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060-300, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

WaterExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • thamyres rangel R barros

    Universidade Estadual Júlio de Mesquita Filho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 9, 2022

Study Start

June 15, 2020

Primary Completion

April 16, 2021

Study Completion

April 16, 2021

Last Updated

February 9, 2022

Record last verified: 2022-01

Locations