Water Intake Associated With Aerobic Exercise in Coronary
Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Aug 2018
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedStudy Start
First participant enrolled
August 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2019
CompletedJuly 28, 2020
July 1, 2020
4 months
June 19, 2017
July 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart rate variability
Indices of heart rate variability
up to six months
Secondary Outcomes (6)
Subjective Effort Perception
up to six months
Subjective Pain Perception
up to six months
Cardiovascular parameter
up to six months
Cardiovascular parameter
up to six months
Cardiorespiratory parameter
up to six months
- +1 more secondary outcomes
Study Arms (4)
Control group in supine position
ACTIVE COMPARATORIntervention: \- Only treadmill aerobic exercise with 60 min recovery in supine position
Hydration group in supine position
EXPERIMENTALInterventions: * Treadmill aerobic exercise with 60 min recovery in supine position * Water intake
Control group in orthostatic position
ACTIVE COMPARATORIntervention: \- Only treadmill aerobic exercise with 10 min recovery in orthostatic position
Hydration group in orthostatic position
EXPERIMENTALInterventions: * Treadmill aerobic exercise with 10 min recovery in orthostatic position * Water intake
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Men with coronary heart disease ischemia, over 45 years
- At least three months of cardiovascular rehabilitation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Luiz Carlos Marques Vanderlei
Presidente Prudente, São Paulo, 19060-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luiz Carlos Marques Vanderlei, PhD
Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2017
First Posted
June 26, 2017
Study Start
August 25, 2018
Primary Completion
December 25, 2018
Study Completion
June 25, 2019
Last Updated
July 28, 2020
Record last verified: 2020-07