Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training

NCT ID: NCT01977222

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-03-31

Brief Summary

Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation. The "thoracic pump" is a contributor to venous return that has been largely unexplored in patients with Fontan physiology. Inspiratory muscle training can improve the performance of competitive athletes across a range of sports and can improve quality of life and functional capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and possibly by improving peripheral blood flow during exercise. One could surmise that the effects of these changes would be particularly important in the Fontan population. The investigators propose to study the effects of inspiratory muscle training on exercise and pulmonary function parameters in a cohort of adult Fontan patients.

The investigators hypothesize that a 12-week program of inspiratory muscle training with an inspiratory impedance threshold device will improve inspiratory muscle strength and endurance, and that this will translate into improved exercise performance in patients with Fontan physiology.

Conditions

Congenital Heart Disease; Single Ventricle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Group Type: EXPERIMENTAL

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Intervention Type: DEVICE

Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.

Interventions

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years of age and older
• Fontan physiology
• Undergoing cardiopulmonary stress testing
• Able to complete a previous cardiopulmonary stress test in the preceding 24 months
• Ability to comply with the inspiratory muscle training protocol
• Ability to return for repeat stress testing and pulmonary function testing 12 weeks after enrollment
• Ability to provide informed consent

Exclusion Criteria

• Status post cardiac transplantation
• Current pregnancy or plans to become pregnant within the next 3 months (for females of childbearing potential)
• Active respiratory infection
• Active cigarette smoker
• Baseline oxygen saturation <90% at the previous clinic visit or exercise test
• Forced expired volume in 1 s and/or vital capacity <60% of predicted at the previous exercise test
• Cardiac surgery or catheter-based procedure in the preceding 18 months or planned surgery or catheter-based procedure within the next 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fred Wu

Assistant in Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fred Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital, Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P00006063

Identifier Type: -

Identifier Source: org_study_id