Chronic Obstructive Pulmonary Disease (COPD) Monitoring

NCT ID: NCT04671888

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2022-11-30

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.

Conditions

COPD; COPD Exacerbation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

COPD patients

Group Type: EXPERIMENTAL

exercises

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martijn Spruit

Role: PRINCIPAL_INVESTIGATOR

Center of Expertise for Chronic Organ Failure

Central Contacts

Elisa Scaccianoce, PhD

Role: CONTACT

Phone: 3405351232

Email: elisa.scaccianoce@medtronic.cm

Other Identifiers

MDT19035

Identifier Type: -

Identifier Source: org_study_id