Comparative Study of Cardiopulmonary Exercise Test Land Versus Water

Status Recruiting

Clinical Trial Summary

At the neck level immersion, the water pressure causes significant displacement of blood from the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses due to the increase in central blood volume and consequent cardiovascular burdens. Immersion in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of organs and systems beneficial to healthy and heart failure individuals. In literature there are a growing number of studies demonstrating the efficacy of exercises performed in the water.

Clinical Trial Description

This study is about to compare the responses of one effort in two different environment. A group of 90 men, age between 55 to 75 years old recruited after a medical consultation, with the diagnostic of Congestive Heart Failure (CHF), under treatment at the Institute of Medicine and Rehabilitation and Institute Dante Pazzanesi, considered clinically stable (no cardiac symptoms or changes in medication for at least 30 days) and Funcional Class I, II, III according to NYHA.

Experimental Design: Patients will perform an test, first on land, and in a week time in a underwater treadmill. The data will be collected in four distinct moments: 1- anaerobic threshold (AT), 2- respiratory compensation point (RCP), 3- maximal effort (ME) and recovery (R). We will compare the following variables: test total time; perceived exertion scale (Borg); Heart rate (HR); Oxygen consumption (VO2); Carbon Dioxide production (VCO2); Oxygen pulse (VO2/FC); the ventilatory efficiency (VE/VO2) and (VE/VCO2); Respiratory quotient (VCO2/VO2); Systolic and Diastolic blood pressure; electrocardiographic changes, compatible with ischemia or arrhythmia. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00989248
Study type	Interventional
Source	University of Sao Paulo General Hospital
Contact	Mauricio K Garcia, Phd
Phone	55 11 9903-7185
Email	mauriciokg@usp.br
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	April 2011
Completion date	July 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparative Study of Cardiopulmonary Exercise Test Land Versus Water — CHF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms