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Water Intake Associated With Aerobic Exercise in Coronary

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ClinicalTrials.gov Identifier: NCT03198806
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Treadmill aerobic exercise in supine position Other: Treadmill aerobic exercise and water intake in supine position Other: Treadmill aerobic exercise in orthostatic position Other: Treadmill aerobic exercise and water intake in orthostatic position Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise
Actual Study Start Date : August 25, 2018
Actual Primary Completion Date : December 25, 2018
Estimated Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group in supine position

Intervention:

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

Other: Treadmill aerobic exercise in supine position
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.

Experimental: Hydration group in supine position

Interventions:

  • Treadmill aerobic exercise with 60 min recovery in supine position
  • Water intake
Other: Treadmill aerobic exercise and water intake in 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.

Active Comparator: Control group in orthostatic position

Intervention:

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

Other: Treadmill aerobic exercise in orthostatic 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.

Experimental: Hydration group in orthostatic position

Interventions:

  • Treadmill aerobic exercise with 10 min recovery in orthostatic position
  • Water intake
Other: Treadmill aerobic exercise and water intake in 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.




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: up to six months ]
    Indices of heart rate variability


Secondary Outcome Measures :
  1. Subjective Effort Perception [ Time Frame: up to six months ]
    Borg Scale

  2. Subjective Pain Perception [ Time Frame: up to six months ]
    Borg CR-10 Scale

  3. Cardiovascular parameter [ Time Frame: up to six months ]
    Heart Rate

  4. Cardiovascular parameter [ Time Frame: up to six months ]
    Blood Pressure

  5. Cardiorespiratory parameter [ Time Frame: up to six months ]
    Respiratory frequency

  6. Cardiorespiratory parameter [ Time Frame: up to six months ]
    Partial Oxygen Saturation



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198806


Contacts
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Contact: Anne Kastelianne França da Silva +551832295819 anne_franca@hotmail.com
Contact: Luiz Carlos Marques Vanderlei, PhD lcmvanderlei@fct.unesp.br

Locations
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Brazil
Luiz Carlos Marques Vanderlei Recruiting
Presidente Prudente, SP, Brazil, 19060-900
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: Luiz Carlos Marques Vanderlei, PhD Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente

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Responsible Party: Luiz Carlos Marques Vanderlei, Principal Investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03198806     History of Changes
Other Study ID Numbers: 54864716800005402
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho:
Autonomic Nervous System
Fluid Therapy
Heart Rate
Exercise
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases