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Different Hydration Strategies Associated With Aerobic Exercise In Coronary

U

Universidade Estadual Paulista Júlio de Mesquita Filho

Status

Unknown

Conditions

Coronary Disease

Treatments

Other: Treadmill aerobic exercise with water intake of a predetermined amount.
Other: Treadmill aerobic exercise without water intake
Other: Treadmill aerobic exercise with water intake according to the desire to drink

Study type

Interventional

Funder types

Other

Identifiers

NCT04977258
34722320.0.0000.5402

Details and patient eligibility

About

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.

Enrollment

31 estimated patients

Sex

Male

Ages

45+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

31 participants in 3 patient groups

Control group
Active Comparator group
Description:
Only treadmill aerobic exercise with 60 min recovery in supine position.
Treatment:
Other: Treadmill aerobic exercise without water intake
Controlled hydration group
Experimental group
Description:
Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake.
Treatment:
Other: Treadmill aerobic exercise with water intake of a predetermined amount.
Ad Libitum hydration group
Experimental group
Description:
Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner.
Treatment:
Other: Treadmill aerobic exercise with water intake according to the desire to drink

Trial contacts and locations

1

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Central trial contact

Luiz Carlos Vanderlei, PhD; Lorena Santos, BPT

Data sourced from clinicaltrials.gov

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