Water Intake Associated With Aerobic Exercise in Coronary

July 26, 2020 updated by: Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho

Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to 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 cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of effort and pain of individuals with autonomic alterations known as the coronary arteries remain poorly understood. In this sense, this study intends to investigate the influence of hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective perception of exertion and pain of coronary arteries submitted to aerobic exercise in the model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation sessions. Only in the second and the fourth session will the volunteers be instructed to ingest a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the first and the third sessions. The outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be evaluated before, during and after exercise. The results of this study will enable professionals working with this population to implement awareness strategies on the importance of fluid intake in cardiovascular rehabilitation programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Brazil
    • SP
      • Presidente Prudente, SP, Brazil, 19060-900
        • Luiz Carlos Marques Vanderlei

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group in supine position

Intervention:

- Only treadmill aerobic exercise with 60 min recovery in supine position
Other: Treadmill aerobic exercise in supine position
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: Hydration group in supine position

Interventions:

  • Treadmill aerobic exercise with 60 min recovery in supine position
  • Water intake
Other: Treadmill aerobic exercise and water intake in supine position
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.
Active Comparator: Control group in orthostatic position

Intervention:

- Only treadmill aerobic exercise with 10 min recovery in orthostatic position
Other: Treadmill aerobic exercise in orthostatic position
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 10 minutes of recovery at the orthostatic position.
Experimental: Hydration group in orthostatic position

Interventions:

  • Treadmill aerobic exercise with 10 min recovery in orthostatic position
  • Water intake
Other: Treadmill aerobic exercise and water intake in orthostatic position
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 10 minutes of recovery at the orthostatic position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: up to six months
Indices of heart rate variability
up to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Effort Perception
Time Frame: up to six months
Borg Scale
up to six months
Subjective Pain Perception
Time Frame: up to six months
Borg CR-10 Scale
up to six months
Cardiovascular parameter
Time Frame: up to six months
Heart Rate
up to six months
Cardiovascular parameter
Time Frame: up to six months
Blood Pressure
up to six months
Cardiorespiratory parameter
Time Frame: up to six months
Respiratory frequency
up to six months
Cardiorespiratory parameter
Time Frame: up to six months
Partial Oxygen Saturation
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 Marques 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 (Actual)

August 25, 2018

Primary Completion (Actual)

December 25, 2018

Study Completion (Actual)

June 25, 2019

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 26, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54864716800005402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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