Inspiratory Muscle Therapy in Subjects With Fontan Circulations

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

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-29

Study Completion Date

2017-08-31

Brief Summary

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Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced respiratory muscle function via inspiratory muscle training (IMT) would improve performance on cardiopulmonary exercise stress testing (CPET).

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Detailed Description

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Adult Fontan subjects were recruited from 2 academic medical centers. Following characterization of pulmonary function and functional class, CPET was performed using incremental and constant work rate protocols. Subjects performed 6-8 weeks of IMT using a handheld inspiratory loading device (Threshold®, Philips); both exercise tests were then repeated. Patient-centered outcome data were collected before and after IMT (RAND-36 assessment and New York Heart Association (NYHA) functional class).

Conditions

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Single-ventricle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental arm - Inspiratory Muscle Training

Single arm study. All subjects will perform 6-8 weeks of inspiratory muscle therapy with cardiopulmonary stress test (both standard and constant work rate) before and after intervention.

Group Type EXPERIMENTAL

Inspiratory muscle therapy

Intervention Type DEVICE

6 weeks of inspiratory muscle therapy

Interventions

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Inspiratory muscle therapy

6 weeks of inspiratory muscle therapy

Intervention Type DEVICE

Other Intervention Names

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No other interventions. Subjects will serve as their own control; single arm study.

Eligibility Criteria

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Inclusion Criteria

Single ventricle physiology status post Fontan palliation

Exclusion Criteria

* The presence of a sub-pulmonary ventricle
* Pregnancy or any contraindication to stress testing (e.g., uncontrolled symptomatic arrhythmia, severe systemic ventricular outflow tract obstruction or uncontrolled symptomatic heart failure).
* Height less than 4'11" due to limitations of the cycle ergometer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes