Different Hydration Strategies Associated With Aerobic Exercise In Coronary

August 9, 2021 updated by: Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho

Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing Aerobic Exercise

The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. The aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. This study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (CR) sessions. The participants will perform CR with mineral water intake in phase three and four. In phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. In phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

31

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 Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19060-900
        • Recruiting
        • Luiz Carlos Masques Vanderlei
        • Contact:

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men with coronary heart disease ischemia, over 45 years
  • At least three months of cardiovascular rehabilitation

Exclusion Criteria:

  • Smokers, alcoholics
  • Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
  • Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
  • Myocardial ischemia and / or severe ventricular arrhythmias during the exercise test

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Only treadmill aerobic exercise with 60 min recovery in supine position.
Other: Treadmill aerobic exercise without water intake
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 60 minutes of recovery at the supine position.
Experimental: Controlled hydration group
Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake.
Other: Treadmill aerobic exercise with water intake of a predetermined amount.
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.
Experimental: Ad Libitum hydration group
Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner.
Other: Treadmill aerobic exercise with water intake according to the desire to drink
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: up to six months
Linear indices of heart rate variability in the time domain (SDNN, rMSSD).
up to six months
Heart rate variability
Time Frame: up to six months
Linear indices of heart rate variability in the frequency domain (HF, LF, LF/HF)
up to six months
Heart rate variability
Time Frame: up to six months
Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)
up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Study Director: Luiz Carlos Vanderlei, PhD, Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente

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 (Anticipated)

August 16, 2021

Primary Completion (Anticipated)

October 26, 2021

Study Completion (Anticipated)

February 26, 2022

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34722320.0.0000.5402

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.

Clinical Trials on Coronary Disease

Clinical Trials on Treadmill aerobic exercise without water intake

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe