Inspiratory Muscle Training in COPD

NCT03438019 | Unknown

• 1 other identifier: 1160788-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Maximal Respiratory Pressures, Inspiratory Muscle Training, TIRE, COPD

Outcome Measures

Primary Outcomes (1)

• Sustained Maximal Inspiratory Pressure (SMIP)

  SMIP is obtained from a maximal sustained inspiratory effort performed through the TIRE method using the PrO2 device. SMIP is documented in pressure time units (PTU) and represents the area under the curve generated from the start to the end of inspiration, from residual volume to total lung capacity.

  Change from baseline to 8 weeks.

Secondary Outcomes (2)

• Maximal Inspiratory Pressure (MIP)

  Change from baseline to 8 weeks.

• Inspiratory Duration (ID)

  Change from baseline to 8 weeks.

Other Outcomes (6)

• Six-minute Walk Test (6MWT)

  Change from baseline to 8 weeks.

• St.George's Respiratory Questionnaire (SGRQ)

  Change from baseline to 8 weeks.

• Modified Medical Research Council (mMRC) Dyspnea Scale

  Change from baseline to 8 weeks.

Study Arms (3)

TIRE IMT

EXPERIMENTAL

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.

Device: PrO2

Standard IMT group

EXPERIMENTAL

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.

Device: Threshold Inspiratory Muscle Trainer

Sham IMT group

SHAM COMPARATOR

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).

Device: Threshold Inspiratory Muscle Trainer

Interventions

PrO2 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).

Also known as: TIRE

TIRE IMT

Threshold Inspiratory Muscle Trainer 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; Standard IMT group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Miami VA Healthcare System: lead

Study Sites (1)

Bruce W Carter VAMC

Miami, Florida, 33125, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael A Campos, MD

CONTACT

3055757000; MCampos1@med.miami.edu

Isabel Vital, MD

CONTACT

vitalisa79@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 19, 2018
• Study Start: June 18, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 31, 2019
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

US (1)