Clinical trial NCT03198806: Water Intake Associated With Aerobic Exercise in Coronary
Official title: Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Autonomic Nervous System
Fluid Therapy
Heart Rate
Exercise
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 31
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart rate variability
timeFrame: up to six months
Secondary outcomes:
measure: Subjective Effort Perception
timeFrame: up to six months
measure: Subjective Pain Perception
timeFrame: up to six months
measure: Cardiovascular parameter
timeFrame: up to six months
measure: Cardiovascular parameter
timeFrame: up to six months
measure: Cardiorespiratory parameter
timeFrame: up to six months
measure: Cardiorespiratory parameter
timeFrame: up to six months
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Luiz Carlos Marques Vanderlei
state: SP
Study officials:
affiliation: Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
name: Luiz Carlos Marques Vanderlei, PhD
role: STUDY_DIRECTOR
References: