Comparative Study of Cardiopulmonary Exercise Test Land Versus Water

Congestive Heart Failure Clinical Trial

— CHF  

Official title:

Comparative Study of Cardiopulmonary Exercise Test on Land and Underwater in Patients With Congestive Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00989248
• Other study ID #: CAPPESq 0532/08
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 2, 2009
• Last updated: April 27, 2011
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2011
• Source: University of Sao Paulo General Hospital
• Contact: Mauricio K Garcia, Phd
• Phone: 55 11 9903-7185
• Email: mauriciokg[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria: Patientes, 55 - 75 year, with Congestive Heart Failure (CHF)Functional class I - II and III according to the New York Heart Association (NYHA) and Injection Fracion 32% to 38%

Exclusion Criteria: Any peripheral artery disease, diabetes, pulmonary disease, hypertension (blood pressure >160/90) or significant cardiovascular morbidity.

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

• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• Aerobic and anaerobic capacity use aquatic exercises
Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure

Locations

Country	Name	City	State
Brazil	Clinical Hospital, School of Medicine, University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To appraisal the cardiopulmonar activities during the effort on land and in immersion		one year	Yes
Secondary	To develop an especific water protocol for reabilitations of patients with Congestive Heart Failure (CHF). The authors expect a beneficial adaptive response to the exercise in water comparing exercise on land.		one year	Yes