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Inspiratory Muscle Therapy in Subjects With Fontan Circulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03339466
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Information provided by (Responsible Party):
Priya Pillutla, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Single-ventricle Device: Inspiratory muscle therapy Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Inspiratory Muscle Function and the Effects of Inspiratory Muscle Training in Subjects With Fontan Physiology
Actual Study Start Date : January 29, 2016
Actual Primary Completion Date : August 24, 2016
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Inspiratory muscle therapy
    6 weeks of inspiratory muscle therapy

Primary Outcome Measures :
  1. Exercise parameters [ Time Frame: 6-8 weeks ]
    Peak VO2 and endurance time are the primary outcome measures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Priya Pillutla, Physician Specialist, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Identifier: NCT03339466    
Other Study ID Numbers: 30799-01
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes