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

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic and anaerobic capacity use aquatic exercises
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Ergospirometry, Cardiopulmonary Exercise Test, Exercises, Immersion

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Hospital, School of Medicine, University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

comparation VE/VO2 and VE/VCO2

Arm Description

Outcomes

Primary Outcome Measures

To appraisal the cardiopulmonar activities during the effort on land and in immersion

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.

Full Information

First Posted
October 2, 2009
Last Updated
April 27, 2011
Sponsor
University of Sao Paulo General Hospital
Collaborators
Instituto Dante Pazzanese de Cardiologia
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1. Study Identification

Unique Protocol Identification Number
NCT00989248
Brief Title
Comparative Study of Cardiopulmonary Exercise Test Land Versus Water
Acronym
CHF
Official Title
Comparative Study of Cardiopulmonary Exercise Test on Land and Underwater in Patients With Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Instituto Dante Pazzanese de Cardiologia

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Ergospirometry, Cardiopulmonary Exercise Test, Exercises, Immersion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
comparation VE/VO2 and VE/VCO2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Aerobic and anaerobic capacity use aquatic exercises
Other Intervention Name(s)
Aerobic and anaerobic capacities
Intervention Description
Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure
Primary Outcome Measure Information:
Title
To appraisal the cardiopulmonar activities during the effort on land and in immersion
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricio K Garcia, Phd
Phone
55 11 9903-7185
Email
mauriciokg@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Fabiola Jomar, MSc
Phone
55 11 55490111
Ext
266
Email
fabjomar@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio K Garcia, PhD
Organizational Affiliation
Shool of Medicine, University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Hospital, School of Medicine, University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04116-040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Massad, Doctor
Phone
55 11 30617097
Email
edmassad@usp.br
First Name & Middle Initial & Last Name & Degree
Fabiola Jomar, MSc
Phone
55 11 55490111
Ext
266
Email
fabjomar@uol.com.br
First Name & Middle Initial & Last Name & Degree
Mauricio K Garcia, MSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
29236912
Citation
Garcia MK, Rizzo L, Yazbek-Junior P, Yutiyama D, Silva FJD, Matheus D, Mastrocolla LE, Massad E. Cardiorespiratory performance of coronary artery disease patients on land versus underwater treadmill tests: a comparative study. Clinics (Sao Paulo). 2017 Nov;72(11):667-674. doi: 10.6061/clinics/2017(11)04.
Results Reference
derived

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Comparative Study of Cardiopulmonary Exercise Test Land Versus Water

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