Different Hydration Strategies Associated With Aerobic Exercise In Coronary

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Disease

Intervention / Treatment
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* Other: Treadmill aerobic exercise without water intake
* Other: Treadmill aerobic exercise with water intake of a predetermined amount.
* Other: Treadmill aerobic exercise with water intake according to the desire to drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Only treadmill aerobic exercise with 60 min recovery in supine position. | Other: Treadmill aerobic exercise without water intake<br>* 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.<br>|
| Experimental: Controlled hydration group<br>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.<br>* 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.<br>|
| Experimental: Ad Libitum hydration group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise