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Different Hydration Strategies Associated With Aerobic Exercise In Coronary

Primary Purpose

Coronary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treadmill aerobic exercise without water intake
Treadmill aerobic exercise with water intake of a predetermined amount.
Treadmill aerobic exercise with water intake according to the desire to drink
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Disease focused on measuring Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Luiz Carlos Masques VanderleiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Controlled hydration group

Ad Libitum hydration group

Arm Description

Only treadmill aerobic exercise with 60 min recovery in supine position.

Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake.

Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner.

Outcomes

Primary Outcome Measures

Heart rate variability
Linear indices of heart rate variability in the time domain (SDNN, rMSSD).
Heart rate variability
Linear indices of heart rate variability in the frequency domain (HF, LF, LF/HF)
Heart rate variability
Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)

Secondary Outcome Measures

Full Information

First Posted
July 15, 2021
Last Updated
August 9, 2021
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT04977258
Brief Title
Different Hydration Strategies Associated With Aerobic Exercise In Coronary
Official Title
Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing Aerobic Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2021 (Anticipated)
Primary Completion Date
October 26, 2021 (Anticipated)
Study Completion Date
February 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Only treadmill aerobic exercise with 60 min recovery in supine position.
Arm Title
Controlled hydration group
Arm Type
Experimental
Arm Description
Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake.
Arm Title
Ad Libitum hydration group
Arm Type
Experimental
Arm Description
Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner.
Intervention Type
Other
Intervention Name(s)
Treadmill aerobic exercise without water intake
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill aerobic exercise with water intake of a predetermined amount.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill aerobic exercise with water intake according to the desire to drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate variability
Description
Linear indices of heart rate variability in the time domain (SDNN, rMSSD).
Time Frame
up to six months
Title
Heart rate variability
Description
Linear indices of heart rate variability in the frequency domain (HF, LF, LF/HF)
Time Frame
up to six months
Title
Heart rate variability
Description
Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)
Time Frame
up to six months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorena Santos, BPT
Phone
55019992359245
Email
lorenaltafin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz Carlos Vanderlei, PhD
Phone
55018997029639
Email
lcmvanderlei@fct.unesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Carlos Vanderlei, PhD
Organizational Affiliation
Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
Official's Role
Study Director
Facility Information:
Facility Name
Luiz Carlos Masques Vanderlei
City
Presidente Prudente
State/Province
São Paulo
ZIP/Postal Code
19060-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorena Santos, BPT
Phone
55019992359245
Email
lorenaltafin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Hydration Strategies Associated With Aerobic Exercise In Coronary

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