Upright Versus Supine Exercise Testing in Fontan-palliated Patients

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

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2). Although one recent study demonstrated that Fontan patients can increase their Max VO2 through diligent cardiac rehabilitation, their ultimate results were still well below average.

It has previously been described that normal, healthy subjects have decreased exercise performance in a supine vs upright position. However, due to high venous pressures and the need for systemic venous return to overcome gravity in order to perfuse the lungs, one might hypothesize that Fontan patients would have increased exercise performance in a supine vs upright position. The investigators are interested in studying this hypothesis.

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Detailed Description

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Conditions

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Fontan Palliation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fontan patients

Subjects will undergo exercise testing in both the supine and upright positions

Supine positioning

Intervention Type OTHER

Subjects underwent exercise testing on a stationary bicycle in the supine position

Upright positioning

Intervention Type OTHER

Subjects underwent exercise testing on a stationary bicycle in the upright position

Healthy controls

Subjects will undergo exercise testing in both the supine and upright positions

Supine positioning

Intervention Type OTHER

Subjects underwent exercise testing on a stationary bicycle in the supine position

Upright positioning

Intervention Type OTHER

Subjects underwent exercise testing on a stationary bicycle in the upright position

Interventions

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Supine positioning

Subjects underwent exercise testing on a stationary bicycle in the supine position

Intervention Type OTHER

Upright positioning

Subjects underwent exercise testing on a stationary bicycle in the upright position

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* S/p Fontan palliation \> 2 years prior
* Age 8 to 30 years

Exclusion Criteria

* Pacemaker dependence
* Severe hypoxemia (O2 saturation \<80%)
* Recent atrial flutter or other arrhythmias
* Protein losing enteropathy (PLE)
* Severe atrioventricular valve regurgitation
* History of cardiac arrest
* Significant comorbidities (renal failure, asthma, etc).

Minimum Eligible Age

8 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes