Different Hydration Strategies Associated With Aerobic Exercise In Coronary

NCT ID: NCT04977258

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-02-26

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Treadmill aerobic exercise without water intake

Intervention Type OTHER

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.

Controlled hydration group

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

Group Type EXPERIMENTAL

Treadmill aerobic exercise with water intake of a predetermined amount.

Intervention Type OTHER

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.

Ad Libitum hydration group

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

Group Type EXPERIMENTAL

Treadmill aerobic exercise with water intake according to the desire to drink

Intervention Type OTHER

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.

Interventions

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Treadmill aerobic exercise without water intake

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

Treadmill aerobic exercise with water intake of a predetermined amount.

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

Treadmill aerobic exercise with water intake according to the desire to drink

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

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Luiz Carlos Marques Vanderlei

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luiz Carlos Vanderlei, PhD

Role: STUDY_DIRECTOR

Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente

Locations

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Luiz Carlos Masques Vanderlei

Presidente Prudente, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Lorena Santos, BPT

Role: CONTACT

55019992359245

Luiz Carlos Vanderlei, PhD

Role: CONTACT

55018997029639

Facility Contacts

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Lorena Santos, BPT

Role: primary

55019992359245

Other Identifiers

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34722320.0.0000.5402

Identifier Type: -

Identifier Source: org_study_id

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