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Chronic Obstructive Pulmonary Disease (COPD) Monitoring (COPD)

Primary Purpose

COPD, COPD Exacerbation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercises
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must have a clinical diagnosis of COPD
  • mMRC (Modified Medical Research Council) Dyspnea Scale Score > 1
  • Subject must be indicated for regular inpatient pulmonary rehabilitation
  • Subject must be hyperinflated, defined as residual volume (RV)>120% of the predicted value, measured by whole body plethysmography
  • Subject must be willing to provide Informed Consent for their participation in the study
  • Subject must be ≥18 years of age

Exclusion Criteria:

  • Subjects who are unable/unwilling to voluntarily participate in the study
  • Subjects who cannot read/write
  • Subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (CWRT)
  • Subject has congenital heart disease
  • Subject has unstable coronary artery disease
  • Subject has an active implanted cardiac device (i.e. IPG, ICD)
  • Subject has heart failure NYHA 4
  • Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study
  • Subject is legally incompetent
  • Subject is pregnant or has suspect to be pregnant
  • Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
  • BORG scale assessment is evaluated as unreliable due to patient's cognitive condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    COPD patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise
    To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during sub-maximal CWRT exercise.
    Correlation between EMG and BORG scale during rehabilitation exercise
    To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during rehabilitation exercise .

    Secondary Outcome Measures

    EMG (Exacerbation symptoms assessment)
    To evaluate the change of EMG amplitude between stable condition and an acute exacerbation episode
    Respiration rate (Exacerbation symptoms assessment)
    To evaluate the change of respiration rate between stable condition and an acute exacerbation episode
    Transcutaneous oxygen saturation (Exacerbation symptoms assessment)
    To evaluate the change of transcutaneous oxygen saturation between stable condition and an acute exacerbation episode
    BORG scale (Exacerbation symptoms assessment)
    To evaluate the change of BORG scale between stable condition and an acute exacerbation episode
    Correlation between respiration rate and BORG scale
    To evaluate the correlation between the respiration rate and BORG scale
    Correlation between transcutaneous oxygen saturation and BORG scale
    To evaluate the correlation between transcutaneous oxygen saturation and BORG scale

    Full Information

    First Posted
    December 4, 2020
    Last Updated
    December 11, 2020
    Sponsor
    Medtronic BRC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04671888
    Brief Title
    Chronic Obstructive Pulmonary Disease (COPD) Monitoring
    Acronym
    COPD
    Official Title
    Chronic Obstructive Pulmonary Disease (COPD) Monitoring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic BRC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present feasibility study aims at assessing whether the EMG of respiratory muscles can serve as an objective marker of dyspnea in COPD patients. The study aims also at evaluating the changes in physiological parameters (i.e., EMG, respiration rate, heart rate, temperature, and SpO2) occurring when simulating daily activities before, during and after acute exacerbations. All this information can be useful to detect the exacerbations earlier or to provide better treatment during the exacerbations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD, COPD Exacerbation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD patients
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    exercises
    Intervention Description
    COPD patients will be asked to wear a data logger system to collect EMG data and respiration parameters during exercise that simulate daily activity (i.e., walking, cycling)
    Primary Outcome Measure Information:
    Title
    Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise
    Description
    To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during sub-maximal CWRT exercise.
    Time Frame
    through study completion, an average of 3 months
    Title
    Correlation between EMG and BORG scale during rehabilitation exercise
    Description
    To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during rehabilitation exercise .
    Time Frame
    through study completion, an average of 3 months
    Secondary Outcome Measure Information:
    Title
    EMG (Exacerbation symptoms assessment)
    Description
    To evaluate the change of EMG amplitude between stable condition and an acute exacerbation episode
    Time Frame
    through study completion, an average of 3 months
    Title
    Respiration rate (Exacerbation symptoms assessment)
    Description
    To evaluate the change of respiration rate between stable condition and an acute exacerbation episode
    Time Frame
    through study completion, an average of 3 months
    Title
    Transcutaneous oxygen saturation (Exacerbation symptoms assessment)
    Description
    To evaluate the change of transcutaneous oxygen saturation between stable condition and an acute exacerbation episode
    Time Frame
    through study completion, an average of 3 months
    Title
    BORG scale (Exacerbation symptoms assessment)
    Description
    To evaluate the change of BORG scale between stable condition and an acute exacerbation episode
    Time Frame
    through study completion, an average of 3 months
    Title
    Correlation between respiration rate and BORG scale
    Description
    To evaluate the correlation between the respiration rate and BORG scale
    Time Frame
    through study completion, an average of 3 months
    Title
    Correlation between transcutaneous oxygen saturation and BORG scale
    Description
    To evaluate the correlation between transcutaneous oxygen saturation and BORG scale
    Time Frame
    through study completion, an average of 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must have a clinical diagnosis of COPD mMRC (Modified Medical Research Council) Dyspnea Scale Score > 1 Subject must be indicated for regular inpatient pulmonary rehabilitation Subject must be hyperinflated, defined as residual volume (RV)>120% of the predicted value, measured by whole body plethysmography Subject must be willing to provide Informed Consent for their participation in the study Subject must be ≥18 years of age Exclusion Criteria: Subjects who are unable/unwilling to voluntarily participate in the study Subjects who cannot read/write Subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (CWRT) Subject has congenital heart disease Subject has unstable coronary artery disease Subject has an active implanted cardiac device (i.e. IPG, ICD) Subject has heart failure NYHA 4 Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study Subject is legally incompetent Subject is pregnant or has suspect to be pregnant Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager BORG scale assessment is evaluated as unreliable due to patient's cognitive condition
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elisa Scaccianoce, PhD
    Phone
    3405351232
    Ext
    +39
    Email
    elisa.scaccianoce@medtronic.cm
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martijn Spruit
    Organizational Affiliation
    Center of Expertise for Chronic Organ Failure
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Chronic Obstructive Pulmonary Disease (COPD) Monitoring

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