Trial Outcomes & Findings for Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training (NCT NCT01977222)

NCT ID: NCT01977222

Last Updated: 2017-11-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline and after 12 weeks of training
• Results posted on: 2017-11-14

Participant Flow

Consecutive adult patients (≥18years old) with Fontan physiology were recruited through the outpatient cardiology clinic at Boston Children's Hospital between April 2014 and December 2014.

One subject who was enrolled and consented dropped out during the initial assessment due to inability to tolerate the metabolic cart during baseline exercise testing.

Participant milestones

Measure	THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER 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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER 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.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training

Baseline characteristics by cohort

Measure	THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.
Age, Continuous	34.8 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Age at Fontan completion	10.7 years STANDARD_DEVIATION 8.0 • n=5 Participants
Fontan type Lateral tunnel	7 Participants n=5 Participants
Fontan type Extracardiac conduit	1 Participants n=5 Participants
Fontan type Atriopulmonary connection	3 Participants n=5 Participants
Maximum inspiratory pressure	87.7 cmH2O STANDARD_DEVIATION 33.0 • n=5 Participants
Peak work rate	116.5 Watts STANDARD_DEVIATION 45.0 • n=5 Participants
Peak relative VO2	68.1 % predicted STANDARD_DEVIATION 14.3 • n=5 Participants
VE/VCO2 slope (ratio)	34.1 ratio STANDARD_DEVIATION 6.7 • n=5 Participants
Peak VE	74.3 L/min STANDARD_DEVIATION 27.8 • n=5 Participants
Peak heart rate	132.3 beats per minute STANDARD_DEVIATION 31.8 • n=5 Participants
Peak tidal volume	2.03 L STANDARD_DEVIATION 0.58 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 12 weeks of training

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.

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

24.0 ml/kg/min Standard Deviation 9.8

SECONDARY outcome

Timeframe: 12 weeks

Population: One individual failed to sustain maximal exercise long enough to complete measurement of cardiac output on her post-intervention study. That individual was therefore left out of the data analysis for cardiac output at peak exercise ONLY.

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=10 Participants 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.

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

6.8 L/min Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 weeks

The 36-Item Short Form (SF-36) Health Survey is a disease-generic survey of an individual's perceived health status and health-related quality of life. There are eight scaled scores, which are the weighted sums of the questions in their section. Each scale is transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. These eight scales are then used to calculate (using a proprietary formula) two summary scores: the physical component score (PCS), representing the four physical health scales (physical functioning, role physical, bodily pain, general health), and the mental component score (MCS), representing the four mental health scales (mental health, role emotional, vitality, social functioning). Component scores are norm-based with a mean of 50 (standardized to the US population) and a standard deviation of 10.

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.

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

50.4 units on a scale Standard Deviation 9.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=10 Participants 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.

Change in Maximum Voluntary Ventilation

113.4 L/min Standard Deviation 31.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after 12 weeks of training

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.

Change in Maximal Inspiratory Pressure

96.0 cmH2O Standard Deviation 33.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.

Change in Oxygen Pulse at Peak Exercise

13.1 mL/beat Standard Deviation 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after 12 weeks of training

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.

Change in Peak Work Rate During Exercise

126.8 Watts Standard Deviation 47.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after 12 weeks of training

Outcome measures

Measure

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER n=11 Participants 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.

Change in VE/VCO2 Slope (Ratio) During Exercise

31.4 ratio Standard Deviation 3.6

Adverse Events

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fred Wu

Boston Children's Hospital

Phone: 6173556508

Email: fred.wu@cardio.chboston.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place