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Comparative Study of Cardiopulmonary Exercise Test Land Versus Water (CHF)

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ClinicalTrials.gov Identifier: NCT00989248
Recruitment Status : Unknown
Verified April 2011 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : October 5, 2009
Last Update Posted : April 28, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Other: Aerobic and anaerobic capacity use aquatic exercises Phase 2 Phase 3

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of Cardiopulmonary Exercise Test on Land and Underwater in Patients With Congestive Heart Failure
Study Start Date : April 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: comparation VE/VO2 and VE/VCO2 Other: Aerobic and anaerobic capacity use aquatic exercises
Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure
Other Name: Aerobic and anaerobic capacities

Outcome Measures

Primary Outcome Measures :
  1. To appraisal the cardiopulmonar activities during the effort on land and in immersion [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: one year ]

Eligibility Criteria

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

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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): NCT00989248

Contact: Mauricio K Garcia, Phd 55 11 9903-7185 mauriciokg@usp.br
Contact: Fabiola Jomar, MSc 55 11 55490111 ext 266 fabjomar@uol.com.br

Clinical Hospital, School of Medicine, University of Sao Paulo Recruiting
Sao Paulo, Brazil, 04116-040
Contact: Eduardo Massad, Doctor    55 11 30617097    edmassad@usp.br   
Contact: Fabiola Jomar, MSc    55 11 55490111 ext 266    fabjomar@uol.com.br   
Principal Investigator: Mauricio K Garcia, MSc         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Instituto Dante Pazzanese de Cardiologia
Study Chair: Mauricio K Garcia, PhD Shool of Medicine, University of São Paulo
More Information

Responsible Party: Mauricio Koprowski Garcia, Instituto de Medicina Física e Reabilitação - HC - FMUSP
ClinicalTrials.gov Identifier: NCT00989248     History of Changes
Other Study ID Numbers: CAPPESq 0532/08
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011

Keywords provided by University of Sao Paulo General Hospital:
Cardiopulmonary Exercise Test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases