Respiratory DiseaseNCT03238209
Surface Respiratory Electromyography Measurements During Treadmill Exercise in Stable Patients With COPD
A study testing Exercise testing in people with Respiratory Disease, run by Guangzhou Institute of Respiratory Disease.
Trial summary
To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Exercise testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Dec 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ,70% and FEV1 ,50% of the predicted value);
- bronchial dilation test (BDT) negative.
Who cannot join
- acute exacerbation in the previous 4 weeks;
- use of oral corticosteroids within 4 weeks;
- smoking more than 10 cigarettes daily;
- history of other respiratory, cardiovascular, neuromuscular, and musculoskeletal diseases that could interfere with the exercise performance and inspiratory muscle activities.
About this study
Official title: Correlation and Compatibility Between Surface Respiratory Electromyography and Transesophageal Diaphragmatic Electromyography Measurements During Treadmill Exercise in Stable Patients With COPD
To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and RMSsc.
Read the detailed description
Subjects This self-matching clinical trial included twenty patients with COPD (age range, 40-80 years) treated at outpatient respiratory medicine departments at the First Affiliated Hospital of Guangzhou Medical University between July 2016 and December 2016. The diagnosis of COPD in all participants were measured using the pulmonary spirometry, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).1 Inclusion criteria: 1) post bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ,70% and FEV1 ,50% of the predicted value); 2) bronchial dilation test (BDT) negative. Exclusion criteria: 1) acute exacerbation in the previous 4 weeks; 2) use of oral corticosteroids within 4 weeks; and 3) smoking more than 10 cigarettes daily; (4) history of other respiratory, cardiovascular, neuromuscular, and musculoskeletal diseases that could interfere with the exercise performance and inspiratory muscle activities.
Study design This study has been reviewed and published on the ClinicalTrials.gov public site (identifier: NCT03017300, Clinical trial date of registration: March 29, 2017). The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University. Informed consent was obtained from COPD patients before participation in this study. To ensure the rights of all participants were protected, the researchers strictly adhered to the Declaration of Helsinki and the ethical principles in designing and conducting clinical research.
Measurements of transesophageal diaphragmatic EMG (EMGdi,es) EMGdi,es is the classic representative index describing activity of diaphragmatic myoelectric signals, the electrical manifestations of the excitation process elicited by action potentials propagating along muscle fiber membranes. The EMG signal is detected with multiple electrodes and then amplified, filtered, and displayed on a screen or digitized to facilitate further analysis. Electromyography of respiratory muscles can be used to assess the level and pattern of their activation so as to detect and diagnose neuromuscular pathology and, when coupled with tests of mechanical function, to assess the efficacy of the muscle's contractile function. Neural respiratory drive, expressed as EMGdi, was measured using a multipair esophageal electrode consisting of nine consecutive coils composed of five electrode pairs positioned in the esophagus and traversing the cardia. EMGdi signals acquired with digital sampling at 2 kHz were bandpass filtered (10 Hz-3 kHz) and amplified. Peak RMS per respiratory cycle was calculated and averaged over 1 min. RMS of the EMGdi signal is thequantification of the total EMGdi power. Theoretically, the RMS of the EMGdi reflects the force output from the brainstem respiratory centre to the peripheral respiratory muscles and also reflect the sensation of dyspnea.
Measurements of surface inspiratory EMG EMG electrodes The electrical activity of the surface inspiratory EMG was derived transcutaneously from pairs of single disposable electrodes (Neotrode, Conmed Corporation, New York, USA). For the commonor ground electrode the same disposable electrode was used. Electrical activity of the sternocleidomastoidmuscles and Intercostals muscles were derived transcutaneously from reusablebipolar electrodes formed by two narrow rim electrodes housings, each containing a 4mm Ag-AgCl sintered electrode pallet (InVivo Metrics, Healdsburg, USA), interconnected with a plastic clip (homemade UMCG, Groningen, The Netherlands) at a distance of14mm. After filling the electrode cavity with electrode gelthe assembly was fixed to the skin by means of double sided adhesives. All EMG signals detected by electrodes were convey to connected to the biological signal acquisition and analysis system (Powerlab 16/35; ADInstruments) by shielded low noise cables.
Electrode placement Surface diaphragmatic EMG (EMGdi,sur): The surface detecting electrode couple were separately placed at the intersection point of the sixth and eight intercostal space and anterior axillary line, at a distance of 5 cm.10 Surface parasternal EMG (EMGpara): The surface detecting electrodes were placed bilaterally in the second intercostal space, about 3 cm parasternal, a reference ground electrode was placed atthe sternum sternal angle.
Surface sternocleidomastoid EMG (EMGsc): Surface detecting electrode were placed on the 1/3 and 2/3 of overall length of sternocleidomastoid, a reference ground electrode was placed at the suprasternal fossa.
Exercise testing All subjects performed a maximal incremental cycle ergometry test in a sitting posture, in order to minimize the effects of muscle activity necessary for body stabilization (Ergoselect 200 K; Cosmed, Rome, Italy). Furthermore, to minimize muscle activity for head positioning, the subjects were instructed to look straight ahead during the measurements. The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed.
- Conditions
- Respiratory Disease
- Being tested
- Exercise testing
- Keywords
- neural respiratory drive, transesophageal diaphragmatic EMG, surface diaphragmatic EMG, surface sternocleidomastoid EMG, surface parasternal intercostal muscle EMG
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testingDiagnostic test
The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed.
| Study group | Role | What they receive |
|---|---|---|
| Exercise testing | Experimental | The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed. Receives: Diagnostic Test: Exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
transesophageal diaphragmatic EMG
transesophageal diaphragmatic EMG was measured using a multipair esophageal electrode consisting of nine consecutive coils composed of five electrode pairs positioned in the esophagus and traversing the cardia
Measured: 30 minute
Secondary outcomes (3)
Surface diaphragmatic EMG
The surface detecting electrode couple were separately placed at the intersection point of the sixth and eight intercostal space and anterior axillary line, at a distance of 5 cm.
Measured: 30 minute
Surface parasternal EMG
The surface detecting electrodes were placed bilaterally in the second intercostal space, about 3 cm parasternal, a reference ground electrode was placed atthe sternum sternal angle.
Measured: 30 minute
Surface sternocleidomastoid EMG
Surface detecting electrode were placed on the 1/3 and 2/3 of overall length of sternocleidomastoid, a reference ground electrode was placed at the suprasternal fossa.
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jul 2016
- Primary completion15 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiliang Wu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238209
- Sponsor's protocol ID
- GuangzhouInsReD
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation and Compatibility Between Surface Respiratory Electromyography and Transesophageal Diaphragmatic Electromyography Measurements During Treadmill Exercise in Stable Patients With COPD
- ClinicalTrials.gov ID
- NCT03238209
- Acronym / sponsor ID
- GuangzhouInsReD
- Conditions
- Respiratory Disease
- Keywords
- neural respiratory drive, transesophageal diaphragmatic EMG, surface diaphragmatic EMG, surface sternocleidomastoid EMG, surface parasternal intercostal muscle EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 3 Aug 2017 (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.
To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and RMSsc.
Detailed description
Subjects This self-matching clinical trial included twenty patients with COPD (age range, 40-80 years) treated at outpatient respiratory medicine departments at the First Affiliated Hospital of Guangzhou Medical University between July 2016 and December 2016. The diagnosis of COPD in all participants were measured using the pulmonary spirometry, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).1 Inclusion criteria: 1) post bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ,70% and FEV1 ,50% of the predicted value); 2) bronchial dilation test (BDT) negative. Exclusion criteria: 1) acute exacerbation in the previous 4 weeks; 2) use of oral corticosteroids within 4 weeks; and 3) smoking more than 10 cigarettes daily; (4) history of other respiratory, cardiovascular, neuromuscular, and musculoskeletal diseases that could interfere with the exercise performance and inspiratory muscle activities.
Study design This study has been reviewed and published on the ClinicalTrials.gov public site (identifier: NCT03017300, Clinical trial date of registration: March 29, 2017). The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University. Informed consent was obtained from COPD patients before participation in this study. To ensure the rights of all participants were protected, the researchers strictly adhered to the Declaration of Helsinki and the ethical principles in designing and conducting clinical research.
Measurements of transesophageal diaphragmatic EMG (EMGdi,es) EMGdi,es is the classic representative index describing activity of diaphragmatic myoelectric signals, the electrical manifestations of the excitation process elicited by action potentials propagating along muscle fiber membranes. The EMG signal is detected with multiple electrodes and then amplified, filtered, and displayed on a screen or digitized to facilitate further analysis. Electromyography of respiratory muscles can be used to assess the level and pattern of their activation so as to detect and diagnose neuromuscular pathology and, when coupled with tests of mechanical function, to assess the efficacy of the muscle's contractile function. Neural respiratory drive, expressed as EMGdi, was measured using a multipair esophageal electrode consisting of nine consecutive coils composed of five electrode pairs positioned in the esophagus and traversing the cardia. EMGdi signals acquired with digital sampling at 2 kHz were bandpass filtered (10 Hz-3 kHz) and amplified. Peak RMS per respiratory cycle was calculated and averaged over 1 min. RMS of the EMGdi signal is thequantification of the total EMGdi power. Theoretically, the RMS of the EMGdi reflects the force output from the brainstem respiratory centre to the peripheral respiratory muscles and also reflect the sensation of dyspnea.
Measurements of surface inspiratory EMG EMG electrodes The electrical activity of the surface inspiratory EMG was derived transcutaneously from pairs of single disposable electrodes (Neotrode, Conmed Corporation, New York, USA). For the commonor ground electrode the same disposable electrode was used. Electrical activity of the sternocleidomastoidmuscles and Intercostals muscles were derived transcutaneously from reusablebipolar electrodes formed by two narrow rim electrodes housings, each containing a 4mm Ag-AgCl sintered electrode pallet (InVivo Metrics, Healdsburg, USA), interconnected with a plastic clip (homemade UMCG, Groningen, The Netherlands) at a distance of14mm. After filling the electrode cavity with electrode gelthe assembly was fixed to the skin by means of double sided adhesives. All EMG signals detected by electrodes were convey to connected to the biological signal acquisition and analysis system (Powerlab 16/35; ADInstruments) by shielded low noise cables.
Electrode placement Surface diaphragmatic EMG (EMGdi,sur): The surface detecting electrode couple were separately placed at the intersection point of the sixth and eight intercostal space and anterior axillary line, at a distance of 5 cm.10 Surface parasternal EMG (EMGpara): The surface detecting electrodes were placed bilaterally in the second intercostal space, about 3 cm parasternal, a reference ground electrode was placed atthe sternum sternal angle.
Surface sternocleidomastoid EMG (EMGsc): Surface detecting electrode were placed on the 1/3 and 2/3 of overall length of sternocleidomastoid, a reference ground electrode was placed at the suprasternal fossa.
Exercise testing All subjects performed a maximal incremental cycle ergometry test in a sitting posture, in order to minimize the effects of muscle activity necessary for body stabilization (Ergoselect 200 K; Cosmed, Rome, Italy). Furthermore, to minimize muscle activity for head positioning, the subjects were instructed to look straight ahead during the measurements. The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise testing | Experimental | Diagnostic Test: Exercise testingThe test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ,70% and FEV1 ,50% of the predicted value);
- bronchial dilation test (BDT) negative.
Key exclusion criteria (4 listed)
- acute exacerbation in the previous 4 weeks;
- use of oral corticosteroids within 4 weeks;
- smoking more than 10 cigarettes daily;
- history of other respiratory, cardiovascular, neuromuscular, and musculoskeletal diseases that could interfere with the exercise performance and inspiratory muscle activities.
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 |
|---|---|---|
| Exercise testingThe test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed. | Diagnostic test | Exercise testing |
Primary outcome
transesophageal diaphragmatic EMG
Time frame: 30 minute
transesophageal diaphragmatic EMG was measured using a multipair esophageal electrode consisting of nine consecutive coils composed of five electrode pairs positioned in the esophagus and traversing the cardia
3 secondary outcomes
Surface diaphragmatic EMG
Time frame: 30 minute
Surface parasternal EMG
Time frame: 30 minute
Surface sternocleidomastoid EMG
Time frame: 30 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise testing in people with Respiratory Disease, run by Guangzhou Institute of Respiratory Disease.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 3 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transesophageal diaphragmatic EMG (time frame: 30 minute). 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 3 Aug 2017.