Chronic Obstructive Pulmonary Disease (COPD) Monitoring

Study Overview
=================
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.

Official Title
-----------------
Chronic Obstructive Pulmonary Disease (COPD) Monitoring

Conditions
-----------------
COPD, COPD Exacerbation

Intervention / Treatment
-----------------
* Other: exercises


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD patients<br> | Other: exercises<br>* 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)<br>|

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 |