Inspiratory Muscle Training in COPD

NCT ID: NCT03438019

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2019-07-31

Brief Summary

This proposal aims at evaluating an inspiratory muscle training (IMT) method not previously tested in COPD called the Test of Incremental Respiratory Endurance (TIRE). As a training method, TIRE promises to provide further benefits over standard IMT because it allows the user to adjust training loads as progress is made, adjusts the training based on day-to-day variations commonly noted in COPD, and provides a graphic representation of the inspiratory effort throughout all inspiration with real-time biofeedback in order to "coach" the user in performing the exercises. The TIRE device can also be used as an assessment tool, not only to measure the commonly used measure of inspiratory muscle strength Maximal Inspiratory Pressure (MIP), but also measuring the MIP variation generated throughout a maximal sustained inspiration. In this way, TIRE integrates MIP over the inspiratory duration (ID), providing a novel derivative measure called the sustained maximal inspiratory pressure or SMIP, that is likely a better surrogate of inspiratory muscle performance in COPD based upon preliminary data. The main goal of this trial is to fully evaluate the utility of TIRE as an IMT method in veterans with COPD. The investigators hypothesize that as a stand-alone therapy, TIRE training is superior to standard IMT in improving inspiratory muscle strength and endurance and in improving COPD-related clinical outcomes.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TIRE IMT

The TIRE IMT group will receive a tablet with the TIRE software installed and a PrO2® device through which they will train. Training consists of six levels (A-F) with six inspirations at each level for a total of 36 breaths. Recovery times between breaths range from 40 to 5 seconds as the subject advances each level. TIRE data will be stored in the tablet for subsequent interrogation and data retrieval.

Group Type: EXPERIMENTAL

PrO2

Intervention Type: DEVICE

The PrO2 device is linked to a tablet via Bluetooth and provides the user with a graphic representation of their inspiratory effort throughout all of inspiration and real-time biofeedback. This device incorporates a standard 2mm leak to avoid glottal closure during maximal inspiration. The PrO2 provides measures of MIP (cmH2O), SMIP (PTU) and ID (seconds).

Standard IMT group

The Standard IMT group will receive a Threshold® Inspiratory Muscle Trainer. This device incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject. Subjects will be instructed to perform up to 36 breaths daily. To compare with TIRE training, we will ask participants to perform this within a 30-minute session.

Group Type: EXPERIMENTAL

Threshold Inspiratory Muscle Trainer

Intervention Type: DEVICE

The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.

Sham IMT group

The Sham IMT group will also receive a Threshold® device and undergo the exact protocol of group 2 but with minimal resistance applied (7 cm H2O, the lowest in the device).

Group Type: SHAM_COMPARATOR

Threshold Inspiratory Muscle Trainer

Intervention Type: DEVICE

The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.

Interventions

PrO2

The PrO2 device is linked to a tablet via Bluetooth and provides the user with a graphic representation of their inspiratory effort throughout all of inspiration and real-time biofeedback. This device incorporates a standard 2mm leak to avoid glottal closure during maximal inspiration. The PrO2 provides measures of MIP (cmH2O), SMIP (PTU) and ID (seconds).

Intervention Type: DEVICE

Threshold Inspiratory Muscle Trainer

The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.

Intervention Type: DEVICE

Other Intervention Names

TIRE

Eligibility Criteria

Inclusion Criteria

• Male or female aged > 40 years with a confirmed diagnosis of COPD by a pulmonologist (presence of risk factors and airflow obstruction) and evidence of inspiratory muscle weakness as defined by the latest American Thoracic Society / European Respiratory Society statement on respiratory muscle training.

Exclusion Criteria

• Refusal to participate in the study, subjects actively undergoing pulmonary rehabilitation, inability to perform the required maneuvers (i.e. patients with cerebrovascular accident or tracheostomy), subjects not in their stable state (i.e. having an acute exacerbation or within 4 weeks of having one) or presence of important comorbidities that may confound the interpretation of TIRE measures (i.e. decompensated heart failure, diaphragmatic paralysis, prior lung surgery, active cancer treatment, etc.). There will be no involvement of vulnerable populations.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miami VA Healthcare System

FED

Sponsor Role: lead

Responsible Party

Michael Campos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bruce W Carter VAMC

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael A Campos, MD

Role: CONTACT

MCampos1@med.miami.edu

3055757000 ext. 3170

Isabel Vital, MD

Role: CONTACT

vitalisa79@gmail.com

Facility Contacts

Magno F. Formiga, PT

Role: primary

magno@miami.edu

305-575-7000 ext. 4064

Other Identifiers

1160788-1

Identifier Type: -

Identifier Source: org_study_id