Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training

NCT01977222 | Completed Results

• 1 other identifier: P00006063
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.

  Baseline and after 12 weeks of training

Secondary Outcomes (2)

• Change in Innocor Measurement (Inert Gas Rebreathing Method) of Cardiac Output at Peak Exercise

  12 weeks

• Change in SF-36 Health Survey Score (Physical Component Summary)

  12 weeks

Other Outcomes (5)

• Change in Maximum Voluntary Ventilation

  12 weeks

• Change in Maximal Inspiratory Pressure

  Baseline and after 12 weeks of training

• Change in Oxygen Pulse at Peak Exercise

  12 weeks

Study Arms (1)

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

EXPERIMENTAL

Device: THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Interventions

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER 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.

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

This pilot study was based on a limited number of patients. In addition, there was incomplete compliance with the prescribed inspiratory muscle training regimen. Finally, our subjects were relatively healthy and mostly had normal MIP at baseline.

Results Point of Contact

• Title: Dr. Fred Wu
• Organization: Boston Children's Hospital

fred.wu@cardio.chboston.org

6173556508

Study Officials

• Fred Wu, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Assistant in Cardiology

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 6, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 14, 2017
• Results First Posted: November 14, 2017

Record last verified: 2017-10

Locations

US (1)