Different Hydration Strategies Associated With Aerobic Exercise In Coronary

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977258
• Other study ID #: 34722320.0.0000.5402
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: February 26, 2022

Study information

• Verified date: August 2021
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Lorena Santos, BPT
• Phone: 55019992359245
• Email: lorenaltafin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: February 26, 2022
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Luiz Carlos Masques Vanderlei	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

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