NCT03339466

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

October 18, 2017

Last Update Submit

January 25, 2024

Conditions

Single-ventricle

Outcome Measures

Primary Outcomes (1)

  • Exercise parameters

    Peak VO2 and endurance time are the primary outcome measures

    6-8 weeks

Study Arms (1)

Experimental arm - Inspiratory Muscle Training

EXPERIMENTAL

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.

Device: Inspiratory muscle therapy

Interventions

Inspiratory muscle therapyDEVICE

6 weeks of inspiratory muscle therapy

Also known as: No other interventions. Subjects will serve as their own control; single arm study.
Experimental arm - Inspiratory Muscle Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single ventricle physiology status post Fontan palliation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Univentricular Heart

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Specialist

Study Record Dates

First Submitted

October 18, 2017

First Posted

November 13, 2017

Study Start

January 29, 2016

Primary Completion

August 24, 2016

Study Completion

August 31, 2017

Last Updated

January 29, 2024

Record last verified: 2024-01