Water Intake Associated With Aerobic Exercise in Coronary

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198806
• Other study ID #: 54864716800005402
• Status: Completed
• Phase: N/A
• Start date: August 25, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2020
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 25, 2019
• Est. primary completion date: December 25, 2018
• 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 Artery Disease

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Luiz Carlos Marques Vanderlei	Presidente Prudente	SP

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	Indices of heart rate variability	up to six months
Secondary	Subjective Effort Perception	Borg Scale	up to six months
Secondary	Subjective Pain Perception	Borg CR-10 Scale	up to six months
Secondary	Cardiovascular parameter	Heart Rate	up to six months
Secondary	Cardiovascular parameter	Blood Pressure	up to six months
Secondary	Cardiorespiratory parameter	Respiratory frequency	up to six months
Secondary	Cardiorespiratory parameter	Partial Oxygen Saturation	up to six months