Chronic Obstructive Pulmonary Disease (COPD)NCT03082924
Surface EMGdi Evaluate the Efficacy of Pulmonary Rehabilitation in Patients With COPD: a Multi Center Prospective Study
A study testing Calibrated cycle ergometer, Threshold loading device and Calibrated cycle ergometer and threshold loading device in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital at 1 site in China.
Trial summary
Pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic obstructive respiratory disease, which has become first-line treatment besides drug therapy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Calibrated cycle ergometer, Threshold loading device and Calibrated cycle ergometer and threshold loading device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jun 2021
- 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
- Patients aged over 40 years old.
- Patients with pulmonary function test of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) < 70%.
- Patients in a clinically stable state
- Patients who signed informed consent.
- No participation in other pulmonary rehabilitation program within the previous 2 months.
Who cannot join
- Patients with signs of an airway infection.
- Patients with metabolic disease and serious cardiovascular disease.
- Patients with Multiple pulmonary bulla.
- Patients with poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, 510282
About this study
Official title: Surface Diaphragm EMG Evaluate the Clinical Efficacy of Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multi Center Prospective Randomized Controlled Study
Pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic obstructive respiratory disease, which has become first-line treatment besides drug therapy. However, in the current clinical evaluation system of pulmonary rehabilitation, there is still a lack of simple, objective index,which can be monitored at any time.Neural respiratory drive , as an important physiological index, is closely related to the symptoms and the severity of the disease. It may be a sensitive indicator to evaluate the effectiveness of pulmonary rehabilitation. Surface EMGdi can accurately evaluate neural respiratory drive , its detection is non-invasive, simple and safety . In recent years, with the development of signal detection and analysis technology, EMG recording is more stable, but as the related research samples were low, surface diaphragm EMG has not yet the establishment of standardization. Therefore, based on the previous work, the project was carried out in a multicenter randomized controlled study,in which the stable stage of COPD patients were included in different ways of pulmonary rehabilitation training, a comprehensive clinical assessment will be conducted before and after training. Compared with the traditional evaluation methods and standard esophageal diaphragmatic electromyography, surface EMGdi detect the changes of neural respiratory drive in patients with COPD,that can help to explore the application value of surface EMGdi in the assessment of chronic obstructive pulmonary disease with pulmonary rehabilitation, to provide a basis for the promotion of the diaphragm and the optimization of pulmonary rehabilitation program.
Read the detailed description
The patients with COPD will participate in a rehabilitation program for 52 weeks.
Participants in the proposed study will be randomly programmed into one of four intervention groups:
- Neither cycle training nor inspiratory muscle training.
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Inspiratory muscle training alone (performing on threshold loading device).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
- Being tested
- Control group, Calibrated cycle ergometer, Threshold loading device, Calibrated cycle ergometer and threshold loading device
- Keywords
- surface EMGdi, pulmonary rehabilitation, inspiratory muscle training, exercise training
- 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.
Control groupDevice
Neither cycle training nor inspiratory muscle training.
Calibrated cycle ergometerDevice
The most common device to perform cycle training is calibrated cycle ergometer.
Threshold loading deviceDevice
Threshold loading device is used to perform inspiratory muscle training.
Calibrated cycle ergometer and threshold loading deviceDevice
Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Neither cycle training nor inspiratory muscle training. Receives: Device: Control group |
| Cycle training group | Experimental | A calibrated cycle ergometer is used to do 30-minute cycling training session 3 days a week. Receives: Device: Calibrated cycle ergometer |
| Inspiratory training group | Experimental | A threshold loading device is used to perform 21-minute inspiratory muscle training 3 days a week. Receives: Device: Threshold loading device |
| Combined group | Experimental | Calibrated cycle ergometer and threshold loading device are applied.A 30-minute cycle training is performed using calibrated cycle ergometer and a 21-minute inspiratory muscle training using threshold loading device 3 days a week. Receives: Device: Calibrated cycle ergometer and threshold loading device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic function(composite outcome measure)
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
Measured: Change from baseline in diaphragm electromyogram.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary outcomes (5)
Inspiratory muscle function(composite outcome measure)
Currently, the maximal inspiratory pressure (PImax) and maximal expiratory pressures(PEmax) are measured by a digital manometer (AZ-8205, AZ Instrument, Taichung City, Taiwan)and combined to evaluate inspiratory muscle function.
Measured: Change from baseline in inspiratory muscle function.(8 weeks later, 26 weeks later, 52 weeks later)
Pulmonary Function(composite outcome measure)
Pulmonary function is measured using a spirometer(PonyFX 229, Cosmed, Rome, Italy) that is calibrated daily.The FEV1 and percent-of-predicted FEV1, FVC and percent-of-predicted FVC which are presented in one report are used to evaluate Pulmonary Function.
Measured: Change from baseline in pulmonary function.(8 weeks later, 26 weeks later, 52 weeks later)
Cardiopulmonary exercise test(composite outcome measure)
Cardiopulmonary exercise test can help to reflect the variables,like maximaloxygen uptake（VO2max）, anaerobic threshold (AT).
Measured: Change from baseline in cardiopulmonary exercise test.(8 weeks later, 26 weeks later, 52 weeks later)
Degree of dyspnea(composite outcome measure)
Difference in the degree of dyspnea can be measured by Borg index.
Measured: Change from baseline in degree of dyspnea.(8 weeks later, 26 weeks later, 52 weeks later)
Exercise capacity(composite outcome measure)
Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
Measured: Change from baseline in exercise performance.(8 weeks later, 26 weeks later, 52 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study startJul 2016
- Primary completionDec 2020
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangdong Pharmaceutical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Zhujiang Hospital,Southern Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082924
- Sponsor's protocol ID
- CX20160902
- Status last verified
- Mar 2017
- First submitted
- 27 Dec 2016
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surface Diaphragm EMG Evaluate the Clinical Efficacy of Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multi Center Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03082924
- Acronym / sponsor ID
- CX20160902
- Keywords
- surface EMGdi, pulmonary rehabilitation, inspiratory muscle training, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangdong Pharmaceutical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
- Study start
- Jul 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 17 Mar 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.
Pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic obstructive respiratory disease, which has become first-line treatment besides drug therapy. However, in the current clinical evaluation system of pulmonary rehabilitation, there is still a lack of simple, objective index,which can be monitored at any time.Neural respiratory drive , as an important physiological index, is closely related to the symptoms and the severity of the disease. It may be a sensitive indicator to evaluate the effectiveness of pulmonary rehabilitation. Surface EMGdi can accurately evaluate neural respiratory drive , its detection is non-invasive, simple and safety . In recent years, with the development of signal detection and analysis technology, EMG recording is more stable, but as the related research samples were low, surface diaphragm EMG has not yet the establishment of standardization. Therefore, based on the previous work, the project was carried out in a multicenter randomized controlled study,in which the stable stage of COPD patients were included in different ways of pulmonary rehabilitation training, a comprehensive clinical assessment will be conducted before and after training. Compared with the traditional evaluation methods and standard esophageal diaphragmatic electromyography, surface EMGdi detect the changes of neural respiratory drive in patients with COPD,that can help to explore the application value of surface EMGdi in the assessment of chronic obstructive pulmonary disease with pulmonary rehabilitation, to provide a basis for the promotion of the diaphragm and the optimization of pulmonary rehabilitation program.
Detailed description
The patients with COPD will participate in a rehabilitation program for 52 weeks.
Participants in the proposed study will be randomly programmed into one of four intervention groups:
- Neither cycle training nor inspiratory muscle training.
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Inspiratory muscle training alone (performing on threshold loading device).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: Control groupNeither cycle training nor inspiratory muscle training. |
| Cycle training group | Experimental | Device: Calibrated cycle ergometerA calibrated cycle ergometer is used to do 30-minute cycling training session 3 days a week. |
| Inspiratory training group | Experimental | Device: Threshold loading deviceA threshold loading device is used to perform 21-minute inspiratory muscle training 3 days a week. |
| Combined group | Experimental | Device: Calibrated cycle ergometer and threshold loading deviceCalibrated cycle ergometer and threshold loading device are applied.A 30-minute cycle training is performed using calibrated cycle ergometer and a 21-minute inspiratory muscle training using threshold loading device 3 days a week. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged over 40 years old.
- Patients with pulmonary function test of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) < 70%.
- Patients in a clinically stable state
- Patients who signed informed consent.
- No participation in other pulmonary rehabilitation program within the previous 2 months.
Key exclusion criteria (4 listed)
- Patients with signs of an airway infection.
- Patients with metabolic disease and serious cardiovascular disease.
- Patients with Multiple pulmonary bulla.
- Patients with poor compliance.
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 |
|---|---|---|
| Control groupNeither cycle training nor inspiratory muscle training. | Device | Control group |
| Calibrated cycle ergometerThe most common device to perform cycle training is calibrated cycle ergometer. | Device | Cycle training group |
| Threshold loading deviceThreshold loading device is used to perform inspiratory muscle training. | Device | Inspiratory training group |
| Calibrated cycle ergometer and threshold loading deviceCombined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring. | Device | Combined group |
Primary outcome
Diaphragmatic function(composite outcome measure)
Time frame: Change from baseline in diaphragm electromyogram.(8 weeks later, 26 weeks later, 52 weeks later)
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
5 secondary outcomes
Inspiratory muscle function(composite outcome measure)
Time frame: Change from baseline in inspiratory muscle function.(8 weeks later, 26 weeks later, 52 weeks later)
Pulmonary Function(composite outcome measure)
Time frame: Change from baseline in pulmonary function.(8 weeks later, 26 weeks later, 52 weeks later)
Cardiopulmonary exercise test(composite outcome measure)
Time frame: Change from baseline in cardiopulmonary exercise test.(8 weeks later, 26 weeks later, 52 weeks later)
Degree of dyspnea(composite outcome measure)
Time frame: Change from baseline in degree of dyspnea.(8 weeks later, 26 weeks later, 52 weeks later)
Exercise capacity(composite outcome measure)
Time frame: Change from baseline in exercise performance.(8 weeks later, 26 weeks later, 52 weeks later)
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 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Xin Chen, Doctor principal investigator
Zhujiang Hospital,Southern Medical Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calibrated cycle ergometer, Threshold loading device and Calibrated cycle ergometer and threshold loading device in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital at 1 site in China.
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 5 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Diaphragmatic function(composite outcome measure) (time frame: Change from baseline in diaphragm electromyogram.(8 weeks later, 26 weeks later, 52 weeks later)). 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 13 Mar 2024.