Chronic Obstructive Pulmonary Disease (COPD) Monitoring

Not Applicable

• Conditions: COPD; COPD Exacerbation
• Interventions: Other: exercises

• Registration Number: NCT04671888
• Lead Sponsor: Medtronic BRC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Study Start: 2021-02
• Primary Completion: 2022-05
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD patients	exercises	-

Primary Outcome Measures

Name	Time	Method
Correlation between EMG and BORG scale during rehabilitation exercise	through study completion, an average of 3 months	To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during rehabilitation exercise .
Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise	through study completion, an average of 3 months	To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during sub-maximal CWRT exercise.

Secondary Outcome Measures

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