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Upright Versus Supine Exercise Testing in Fontan-palliated Patients

Study of Upright Versus Supine Exercise Testing in Fontan-palliated Patients, Compared With Healthy Controls, to Evaluate for Postural Effects on Exercise Parameters

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00633815
Enrollment
45
Registered
2008-03-12
Start date
2008-01-31
Completion date
2008-11-30
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fontan Palliation

Keywords

Supine, Upright

Brief summary

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.

Interventions

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

OTHERUpright positioning

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

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 30 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Exercise Capacity40 minutesWatts

Secondary

MeasureTime frameDescription
Peak Oxygen Volume (Peak VO2)40 minutesmilliliters per kilogram of body weight per minute (ml/kg/min)
Peak Heart Rate40 minutesbeats per minute
Peak Pulmonary Artery Pressure40 minutesmillimeters of mercury (mmHg)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026