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Water Intake Associated With Aerobic Exercise in Coronary

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treadmill aerobic exercise in supine position
Treadmill aerobic exercise and water intake in supine position
Treadmill aerobic exercise in orthostatic position
Treadmill aerobic exercise and water intake in orthostatic position
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 Artery 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 Marques Vanderlei

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Control group in supine position

Hydration group in supine position

Control group in orthostatic position

Hydration group in orthostatic position

Arm Description

Intervention: - Only treadmill aerobic exercise with 60 min recovery in supine position

Interventions: Treadmill aerobic exercise with 60 min recovery in supine position Water intake

Intervention: - Only treadmill aerobic exercise with 10 min recovery in orthostatic position

Interventions: Treadmill aerobic exercise with 10 min recovery in orthostatic position Water intake

Outcomes

Primary Outcome Measures

Heart rate variability
Indices of heart rate variability

Secondary Outcome Measures

Subjective Effort Perception
Borg Scale
Subjective Pain Perception
Borg CR-10 Scale
Cardiovascular parameter
Heart Rate
Cardiovascular parameter
Blood Pressure
Cardiorespiratory parameter
Respiratory frequency
Cardiorespiratory parameter
Partial Oxygen Saturation

Full Information

First Posted
June 19, 2017
Last Updated
July 26, 2020
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT03198806
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 25, 2018 (Actual)
Primary Completion Date
December 25, 2018 (Actual)
Study Completion Date
June 25, 2019 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery 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
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group in supine position
Arm Type
Active Comparator
Arm Description
Intervention: - Only treadmill aerobic exercise with 60 min recovery in supine position
Arm Title
Hydration group in supine position
Arm Type
Experimental
Arm Description
Interventions: Treadmill aerobic exercise with 60 min recovery in supine position Water intake
Arm Title
Control group in orthostatic position
Arm Type
Active Comparator
Arm Description
Intervention: - Only treadmill aerobic exercise with 10 min recovery in orthostatic position
Arm Title
Hydration group in orthostatic position
Arm Type
Experimental
Arm Description
Interventions: Treadmill aerobic exercise with 10 min recovery in orthostatic position Water intake
Intervention Type
Other
Intervention Name(s)
Treadmill aerobic exercise in supine position
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 and water intake in supine position
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 in orthostatic position
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill aerobic exercise and water intake in orthostatic position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate variability
Description
Indices of heart rate variability
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
Subjective Effort Perception
Description
Borg Scale
Time Frame
up to six months
Title
Subjective Pain Perception
Description
Borg CR-10 Scale
Time Frame
up to six months
Title
Cardiovascular parameter
Description
Heart Rate
Time Frame
up to six months
Title
Cardiovascular parameter
Description
Blood Pressure
Time Frame
up to six months
Title
Cardiorespiratory parameter
Description
Respiratory frequency
Time Frame
up to six months
Title
Cardiorespiratory parameter
Description
Partial Oxygen Saturation
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Carlos Marques Vanderlei, PhD
Organizational Affiliation
Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
Official's Role
Study Director
Facility Information:
Facility Name
Luiz Carlos Marques Vanderlei
City
Presidente Prudente
State/Province
SP
ZIP/Postal Code
19060-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Water Intake Associated With Aerobic Exercise in Coronary

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