Chronic Obstructive Pulmonary Disease(COPD)NCT02326181
Effects of Inspiratory and Expiratory Pressure Training Methods in Patients With Chronic Obstructive Pulmonary Disease
A study testing inspiratory pressure training group and mixed training group in people with Chronic Obstructive Pulmonary Disease(COPD), run by Zhujiang Hospital at 1 site in China.
Trial summary
The study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease(COPD)
- What is being tested?
- inspiratory pressure training group and mixed training group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable COPD with diagnosis of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) < 70%
Who cannot join
- Cancer Unstable heart disease Neuromusculoskeletal disorder mental disorder Active smokers
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang hospital
Guangzhou, Guangdong, 510000
Liqing Wang, 86-02062783391, wliqing07@gmail.com
Xin Chen
About this study
Official title: Effects of Inspiratory and Respiratory Pressure Threshold Training in Patients With Chronic Obstructive Pulmonary Disease
The study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.
Read the detailed description
We will study 60 patients diagnosed of chronic obstructive pulmonary disease.The monitoring will be done for 8 weeks. Pressure-threshold respiratory trainers were calibrated to provide different loads according to the patients against inspiration (IMST) or expiration (EMST). Those chronic obstructive pulmonary disease clinically stable patients stratified from mild to very severe GOLD stages, were blinded to randomly divided into 3 different groups: a)control group:without any training;b) inspiratory and expiratory pressure threshold training group: trained with the pressure threshold trainer twice time daily with 15minutes' duration;c)inspiratory pressure threshold training group:trained with the pressure threshold trainer twice time daily with 15 minutes' duration,different from the b group,the expiratory pressure threshold is calibrated at 0.
- Being tested
- inspiratory pressure training group, mixed training group
- Keywords
- respiratory muscle training, respiratory muscle strength, respiratory endurance test, 6-minute walking test
- 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.
inspiratory pressure training groupDevice
The respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) .
mixed training groupDevice
The respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) and expiration(EMST).
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | without inspiratory and expiratory pressure threshold training |
| inspiratory pressure training group | Experimental | The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer. Receives: Device: inspiratory pressure training group |
| mixed training group | Experimental | The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer. Receives: Device: mixed training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory muscle strength measurements
Measured: baseline and 8 weeks
Secondary outcomes (4)
respiratory muscle endurance text
Measured: baseline and 8 weeks
6-minute walking test
Measured: baseline and 12 weeks
perceived exertion for leg fatigue (Borg-scale)
Measured: baseline and 8 weeks
modified british medical research council(mMRC) questionnaire
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326181
- Sponsor's protocol ID
- ZJH21400964
- Status last verified
- Dec 2014
- First submitted
- 21 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu W, Li R, Guan L, Wang K, Hu Y, Xu L, Zhou L, Chen R, Chen X. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018 Nov 20;19(1):225. doi: 10.1186/s12931-018-0917-6.
PubMed 30458805
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory and Respiratory Pressure Threshold Training in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02326181
- Acronym / sponsor ID
- ZJH21400964
- Keywords
- respiratory muscle training, respiratory muscle strength, respiratory endurance test, 6-minute walking test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Dec 2014 (estimated)
- 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 study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.
Detailed description
We will study 60 patients diagnosed of chronic obstructive pulmonary disease.The monitoring will be done for 8 weeks. Pressure-threshold respiratory trainers were calibrated to provide different loads according to the patients against inspiration (IMST) or expiration (EMST). Those chronic obstructive pulmonary disease clinically stable patients stratified from mild to very severe GOLD stages, were blinded to randomly divided into 3 different groups: a)control group:without any training;b) inspiratory and expiratory pressure threshold training group: trained with the pressure threshold trainer twice time daily with 15minutes' duration;c)inspiratory pressure threshold training group:trained with the pressure threshold trainer twice time daily with 15 minutes' duration,different from the b group,the expiratory pressure threshold is calibrated at 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –without inspiratory and expiratory pressure threshold training |
| inspiratory pressure training group | Experimental | Device: inspiratory pressure training groupThe patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer. |
| mixed training group | Experimental | Device: mixed training groupThe patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically stable COPD with diagnosis of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) < 70%
Key exclusion criteria (1 listed)
- Cancer Unstable heart disease Neuromusculoskeletal disorder mental disorder Active smokers
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 |
|---|---|---|
| inspiratory pressure training groupThe respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) . | Device | inspiratory pressure training group |
| mixed training groupThe respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) and expiration(EMST). | Device | mixed training group |
Primary outcome
respiratory muscle strength measurements
Time frame: baseline and 8 weeks
4 secondary outcomes
respiratory muscle endurance text
Time frame: baseline and 8 weeks
6-minute walking test
Time frame: baseline and 12 weeks
perceived exertion for leg fatigue (Borg-scale)
Time frame: baseline and 8 weeks
modified british medical research council(mMRC) questionnaire
Time frame: baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
- Derived from this study: PubMed 30458805Xu W, Li R, Guan L, Wang K, Hu Y, Xu L, Zhou L, Chen R, Chen X. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018 Nov 20;19(1):225. doi: 10.1186/s12931-018-0917-6.
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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.
Xin Chen, Doctor principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory pressure training group and mixed training group 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 1 inclusion and 1 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 25 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liqing Wang, Doctor (+86-02062783391, wliqing07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory muscle strength measurements (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326181, which also lists 1 linked publication.
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 25 Dec 2014.