Different Hydration Strategies Associated With Aerobic Exercise In Coronary

Not Applicable

• Conditions: Coronary Disease
• Interventions: Other: Treadmill aerobic exercise with water intake of a predetermined amount.; Other: Treadmill aerobic exercise with water intake according to the desire to drink; Other: Treadmill aerobic exercise without water intake

• Registration Number: NCT04977258
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-11
• Study Start: 2021-08-16
• Primary Completion: 2021-10-26
• Study Completion: 2022-02-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Controlled hydration group	Treadmill aerobic exercise with water intake of a predetermined amount.	Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake.
Ad Libitum hydration group	Treadmill aerobic exercise with water intake according to the desire to drink	Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner.
Control group	Treadmill aerobic exercise without water intake	Only treadmill aerobic exercise with 60 min recovery in supine position.

Primary Outcome Measures

Name	Time	Method
Heart rate variability	up to six months	Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)

Trial Locations

Locations (1)

Luiz Carlos Masques Vanderlei; 🇧🇷 Presidente Prudente, São Paulo, Brazil