COPDCOPDNCT04671888
Chronic Obstructive Pulmonary Disease (COPD) Monitoring
A study testing exercises in people with COPD and COPD Exacerbation, run by Medtronic BRC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- exercises
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | Not described Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: through study completion, an average of 3 months
Secondary outcomes (6)
EMG (Exacerbation symptoms assessment)
To evaluate the change of EMG amplitude between stable condition and an acute exacerbation episode
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startFeb 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martijn Spruit, Principal investigator, Center of Expertise for Chronic Organ Failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671888
- Sponsor's protocol ID
- MDT19035
- Acronym
- COPD
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease (COPD) Monitoring
- ClinicalTrials.gov ID
- NCT04671888
- Acronym / sponsor ID
- COPD / MDT19035
- Conditions
- COPD, COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Other: exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisesCOPD 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) | Other | COPD patients |
Primary outcome
Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise
Time frame: 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.
Correlation between EMG and BORG scale during rehabilitation exercise
Time frame: 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 .
6 secondary outcomes
EMG (Exacerbation symptoms assessment)
Time frame: through study completion, an average of 3 months
Respiration rate (Exacerbation symptoms assessment)
Time frame: through study completion, an average of 3 months
Transcutaneous oxygen saturation (Exacerbation symptoms assessment)
Time frame: through study completion, an average of 3 months
BORG scale (Exacerbation symptoms assessment)
Time frame: through study completion, an average of 3 months
Correlation between respiration rate and BORG scale
Time frame: through study completion, an average of 3 months
Correlation between transcutaneous oxygen saturation and BORG scale
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn Spruit principal investigator
Center of Expertise for Chronic Organ Failure
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with COPD and COPD Exacerbation, run by Medtronic BRC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Scaccianoce, PhD (3405351232 ext. +39, elisa.scaccianoce@medtronic.cm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise (time frame: through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.