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Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Primary Purpose

Single-ventricle

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle therapy
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Single-ventricle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Exercise parameters
    Peak VO2 and endurance time are the primary outcome measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 2017
    Last Updated
    November 8, 2017
    Sponsor
    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03339466
    Brief Title
    Inspiratory Muscle Therapy in Subjects With Fontan Circulations
    Official Title
    A Pilot Study of Inspiratory Muscle Function and the Effects of Inspiratory Muscle Training in Subjects With Fontan Physiology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 29, 2016 (Actual)
    Primary Completion Date
    August 24, 2016 (Actual)
    Study Completion Date
    August 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Single-ventricle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Inspiratory muscle therapy
    Intervention Description
    6 weeks of inspiratory muscle therapy
    Primary Outcome Measure Information:
    Title
    Exercise parameters
    Description
    Peak VO2 and endurance time are the primary outcome measures
    Time Frame
    6-8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Inspiratory Muscle Therapy in Subjects With Fontan Circulations

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