Chronic Obstructive Pulmonary Disease (COPD) Monitoring (COPD)

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.

Study Overview

• Status: Unknown
• Conditions: COPD; COPD Exacerbation
• Intervention / Treatment: Other: exercises

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD patients	Other: exercises; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 3 months
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 .	through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMG (Exacerbation symptoms assessment)	To evaluate the change of EMG amplitude between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Respiration rate (Exacerbation symptoms assessment)	To evaluate the change of respiration rate between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Transcutaneous oxygen saturation (Exacerbation symptoms assessment)	To evaluate the change of transcutaneous oxygen saturation between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
BORG scale (Exacerbation symptoms assessment)	To evaluate the change of BORG scale between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Correlation between respiration rate and BORG scale	To evaluate the correlation between the respiration rate and BORG scale	through study completion, an average of 3 months
Correlation between transcutaneous oxygen saturation and BORG scale	To evaluate the correlation between transcutaneous oxygen saturation and BORG scale	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: Martijn Spruit, Center of Expertise for Chronic Organ Failure

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MDT19035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No