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Completed

NCT Number: NCT03198806

Water Intake Associated With Aerobic Exercise in Coronary

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.

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Key information

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Luiz Carlos Marques Vanderlei

Presidente Prudente, São Paulo, 19060-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill aerobic exercise in supine position

Other

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.

Treadmill aerobic exercise and water intake in supine position

Other

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.

Treadmill aerobic exercise in orthostatic position

Other

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.

Treadmill aerobic exercise and water intake in orthostatic position

Other

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.

Primary outcomes

  1. Heart rate variability

    Time frame: up to six months

    Indices of heart rate variability

Secondary outcomes

  1. Subjective Effort Perception

    Time frame: up to six months

    Borg Scale

  2. Subjective Pain Perception

    Time frame: up to six months

    Borg CR-10 Scale

  3. Cardiovascular parameter

    Time frame: up to six months

    Heart Rate

  4. Cardiovascular parameter

    Time frame: up to six months

    Blood Pressure

  5. Cardiorespiratory parameter

    Time frame: up to six months

    Respiratory frequency

  6. Cardiorespiratory parameter

    Time frame: up to six months

    Partial Oxygen Saturation

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 26, 2017
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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