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

April 27, 2011 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04116-040
        • Recruiting
        • Clinical Hospital, School of Medicine, University of Sao Paulo
        • Contact:
        • Contact:
          • Eduardo Massad, Doctor
          • Phone Number: 55 11 30617097
          • Email: edmassad@usp.br
        • Principal Investigator:
          • Mauricio K Garcia, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Aerobic and anaerobic capacities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To appraisal the cardiopulmonar activities during the effort on land and in immersion
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Instituto Dante Pazzanese de Cardiologia

Investigators

  • Study Chair: Mauricio K Garcia, PhD, Shool of Medicine, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPESq 0532/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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