Different Hydration Strategies Associated With Aerobic Exercise In Coronary
Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
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
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedStudy Start
First participant enrolled
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2022
CompletedAugust 11, 2021
August 1, 2021
2 months
July 15, 2021
August 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Heart rate variability
Linear indices of heart rate variability in the time domain (SDNN, rMSSD).
up to six months
Heart rate variability
Linear indices of heart rate variability in the frequency domain (HF, LF, LF/HF)
up to six months
Heart rate variability
Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)
up to six months
Study Arms (3)
Control group
ACTIVE COMPARATOROnly treadmill aerobic exercise with 60 min recovery in supine position.
Controlled hydration group
EXPERIMENTALTreadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake.
Ad Libitum hydration group
EXPERIMENTALTreadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner.
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 and water intake followed by 60 minutes of recovery at the supine 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 Masques Vanderlei
Presidente Prudente, São Paulo, 19060-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luiz Carlos Vanderlei, PhD
Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 15, 2021
First Posted
July 26, 2021
Study Start
August 16, 2021
Primary Completion
October 26, 2021
Study Completion
February 26, 2022
Last Updated
August 11, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share