Chronic Obstructive Pulmonary Disease (COPD) Monitoring

NCT04671888 | Unknown

• 1 other identifier: MDT19035
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• EMG (Exacerbation symptoms assessment)

  through study completion, an average of 3 months

• Respiration rate (Exacerbation symptoms assessment)

  through study completion, an average of 3 months

• Transcutaneous oxygen saturation (Exacerbation symptoms assessment)

  through study completion, an average of 3 months

• BORG scale (Exacerbation symptoms assessment)

  through study completion, an average of 3 months

• Correlation between respiration rate and BORG scale

  through study completion, an average of 3 months

Study Arms (1)

COPD patients

EXPERIMENTAL

Other: exercises

Interventions

exercises 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)

COPD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic BRC: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martijn Spruit

  Center of Expertise for Chronic Organ Failure

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Scaccianoce, PhD

CONTACT

3405351232; elisa.scaccianoce@medtronic.cm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: February 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share