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Trial record 2 of 54 for:    COPD OR COPD OR chronic obstructive pulmonary disease OR chronic bronchitis OR emphysema | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Inspiratory Muscle Training in COPD

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ClinicalTrials.gov Identifier: NCT03438019
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Campos, Miami VA Healthcare System

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.

Condition or disease Intervention/treatment Phase
COPD Device: PrO2 Device: Threshold Inspiratory Muscle Trainer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Strength and Endurance Training in Veterans With COPD
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: 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.
Device: 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).
Other Name: TIRE

Experimental: 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.
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.

Sham Comparator: 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).
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.




Primary Outcome Measures :
  1. Sustained Maximal Inspiratory Pressure (SMIP) [ Time Frame: Change from baseline to 8 weeks. ]
    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.


Secondary Outcome Measures :
  1. Maximal Inspiratory Pressure (MIP) [ Time Frame: Change from baseline to 8 weeks. ]
    MIP is obtained from a maximal inspiratory effort from residual volume using the TIRE software and recorded in centimeters of water.

  2. Inspiratory Duration (ID) [ Time Frame: Change from baseline to 8 weeks. ]
    ID is obtained from a maximal and sustained inspiratory effort using the TIRE software and recorded in seconds.


Other Outcome Measures:
  1. Six-minute Walk Test (6MWT) [ Time Frame: Change from baseline to 8 weeks. ]
    Sub-maximal exercise test used to assess aerobic capacity and endurance. The best distance covered over a time of 6 minutes is recorded in metres.

  2. St.George's Respiratory Questionnaire (SGRQ) [ Time Frame: Change from baseline to 8 weeks. ]
    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.

  3. Modified Medical Research Council (mMRC) Dyspnea Scale [ Time Frame: Change from baseline to 8 weeks. ]
    This scale ranges from zero to four, with higher scores indicating a greater degree of breathlessness.

  4. COPD Assessment Test (CAT) [ Time Frame: Change from baseline to 8 weeks. ]
    This instrument that can quantify the impact of COPD on the patient's health. The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD.

  5. Fat Free Mass Index (FFMI) [ Time Frame: Change from baseline to 8 weeks. ]
    FFMI is calculated using the following formula: FFMI = (Lean Mass / 2.2) / ((Height in feet * 12.0) * 0.0254) squared. A person is said to be in the Average Norms of Muscle Mass Interpretation when his FFMI in pounds is between 18 and 19.

  6. Short Performance Physical Battery (SPPB) [ Time Frame: Change from baseline to 8 weeks. ]
    The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The scores range from 0 (worst performance) to 12 (best performance).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438019


Contacts
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Contact: Michael A Campos, MD 3055757000 ext 3170 MCampos1@med.miami.edu
Contact: Isabel Vital, MD vitalisa79@gmail.com

Locations
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United States, Florida
Bruce W Carter VAMC Recruiting
Miami, Florida, United States, 33125
Contact: Magno F. Formiga, PT    305-575-7000 ext 4064    magno@miami.edu   
Sponsors and Collaborators
Miami VA Healthcare System

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Responsible Party: Michael Campos, Principal Investigator, Miami VA Healthcare System
ClinicalTrials.gov Identifier: NCT03438019     History of Changes
Other Study ID Numbers: 1160788-1
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Campos, Miami VA Healthcare System:
Maximal Respiratory Pressures, Inspiratory Muscle Training, TIRE, COPD
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes