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Inspiratory Muscle Training in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438019
Recruitment Status : Unknown
Verified July 2018 by Michael Campos, Miami VA Healthcare System.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Campos, Miami VA Healthcare System

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date July 20, 2018
Actual Study Start Date  ICMJE June 18, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 15, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Inspiratory Muscle Training in COPD
Official Title  ICMJE Inspiratory Muscle Strength and Endurance Training in Veterans With COPD
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: PrO2
  • 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.
    Intervention: Device: Threshold Inspiratory Muscle Trainer
  • 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).
    Intervention: Device: Threshold Inspiratory Muscle Trainer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438019
Other Study ID Numbers  ICMJE 1160788-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Campos, Miami VA Healthcare System
Study Sponsor  ICMJE Miami VA Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Miami VA Healthcare System
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP