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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Instituto Dante Pazzanese de Cardiologia
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00989248
First received: October 2, 2009
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Congestive Heart Failure
 Other: Aerobic and anaerobic capacity use aquatic exercises
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of Cardiopulmonary Exercise Test on Land and Underwater in Patients With Congestive Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • To appraisal the cardiopulmonar activities during the effort on land and in immersion [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: April 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989248

Contacts
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

Locations
Brazil
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
Investigators
Study Chair: Mauricio K Garcia, PhD Shool of Medicine, University of São Paulo
  More Information

No publications provided

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
Study First Received: October 2, 2009
Last Updated: April 27, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013