Comparative Study of Cardiopulmonary Exercise Test Land Versus Water

NCT ID: NCT00989248

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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comparation VE/VO2 and VE/VCO2

Group Type EXPERIMENTAL

Aerobic and anaerobic capacity use aquatic exercises

Intervention Type OTHER

Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure

Interventions

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Aerobic and anaerobic capacity use aquatic exercises

Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure

Intervention Type OTHER

Other Intervention Names

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Aerobic and anaerobic capacities

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Instituto de Medicina Física e Reabilitação - HC - FMUSP

Principal Investigators

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Mauricio K Garcia, PhD

Role: STUDY_CHAIR

Shool of Medicine, University of São Paulo

Locations

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Clinical Hospital, School of Medicine, University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mauricio K Garcia, Phd

Role: CONTACT

55 11 9903-7185

Fabiola Jomar, MSc

Role: CONTACT

55 11 55490111 ext. 266

Facility Contacts

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Eduardo Massad, Doctor

Role: primary

55 11 30617097

Fabiola Jomar, MSc

Role: backup

55 11 55490111 ext. 266

References

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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.

Reference Type DERIVED
PMID: 29236912 (View on PubMed)

Other Identifiers

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CAPPESq 0532/08

Identifier Type: -

Identifier Source: org_study_id

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