Pulmonary Disease, Chronic ObstructiveNCT06063733
Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD
A study testing Digital pursed lip breathing intervention in people with Pulmonary Disease, Chronic Obstructive, run by Manchester Metropolitan University at 1 site in China.
Trial summary
The goal of this pre-post design clinical trial is to develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones (DT-PLB) and to preliminarily evaluate its feasibility and effects in stable Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Digital pursed lip breathing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 20 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with COPD satisfying GOLD criteria (Agusti, 2022) ;
- Being Chinese;
- Able to understand, speak, and hear;
- Clinically stable for at least three months prior to enrollment (Soler-Cataluna et al., 2018) ;
- The classification of GOLD grades for patients is mild, moderate, and severe, which means: FEV1/FVC<70%, FEV1>30%pre (Agusti, 2022) ;
- Participants who were mindful about the IT technology and known how to use a smartphone.
Who cannot join
- Impaired hand function causing inability to use the application;
- Have disorders in pleural effusion, pulmonary malignancy, heart diseases, stroke with sequels;
- Patients who have oral or nasal diseases cannot complete the exercise.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Houqiang Huang, Master, +8618715799162, 21442584@stu.mmu.ac.uk
About this study
The goal of this pre-post design clinical trial is to develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones (DT-PLB) and to preliminarily evaluate its feasibility and effects in stable Chronic Obstructive Pulmonary Disease (COPD). The main objectives are:
- To develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones for managing breathing exercises in stable COPD patients.
- To pilot the methodological procedures of the pre-post study.
- To determine the recruitment rate, retention rate, attrition rate, and software usage compliance during the subject recruitment and follow-up process of the pre-post study.
- To evaluate the perception and satisfaction of COPD patients using the DT-PLB.
- To preliminarily examine the effects of using the DT-PLB intervention on COPD patients, including the six-minute walking test, FEV1% predicted, FEV1/FVC, mMRC scale, COPD assessment test scale, and health points.
- To identify any potential adverse events associated with the implementation of DT-PLB.
Read more
Participants will perform the following tasks during the intervention:
- Register a personal account on the DT-PLB software.
- Acquire knowledge and skills related to Pursed Lip Breathing by watching instructional videos.
- Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software.
- Earn health points by completing specific actions as instructed.
- Optionally post individual texts on the peer forum for peer support within the DT-PLB software.
- Complete two outcome assessments as scheduled.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Digital pursed lip breathing intervention
- Keywords
- Pursed lip breathing, Behavioral interventions, Gamification
- 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.
Digital pursed lip breathing interventionOther
After registration, participants will watch an educational video on the developed software, covering the definition, benefits, and techniques of pursed lip breathing. Following this, participants will engage in pursed lip breathing interventions, guided by voice and animated instructions from the software. These sessions will occur three times daily (morning, afternoon, and night) for 10 minutes each, lasting for 8 weeks.
After each session, participants can choose to post texts on a peer social forum for peer support. Fellow participants can give 'comments' or 'likes'. The principal researcher will oversee texts, peer comments, removing information containing personal data, medical recommendations, and negative comments.
Additionally, participants can earn health points by performing specific actions (e.g., watching the educational video and practicing pursed lip breathing) on the software, encouraging their participation in related activities.
| Study group | Role | What they receive |
|---|---|---|
| Digital PLB intervention | Experimental | Participants will perform the following tasks during the intervention:
1. Register a personal account on the theory-based pursed lip breathing intervention protocol software system installed on smartphones(DT-PLB).
2. Acquire knowledge and skills related to pursed lip breathing by watching instructional videos.
3. Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software.
4. Earn health points by completing specific actions as instructed.
5. Optionally post individual texts on the peer forum for peer support within the DT-PLB software.
6. Complete two outcome assessments as scheduled. Receives: Other: Digital pursed lip breathing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of participants who participate in the study divided by the number of participants eligible for participation
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
Retention rate
The number of subjects who complete the study divided by the number of subjects who participate in the study
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
Attrition rate
The number of subjects who drop out after participation divided by the number of subjects who participate in the study
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
Software usage Compliance
The compliance rate is one of compliance outcomes, reflecting the level of patient engagement in the intervention. Overall compliance will be defined as the compliance averaged in all patients. Compliance rate = (actual number of participation in the intervention/planned number of sessions)x 100%. In addition, minutes-consuming recorded on the software for participants during the research will be used to complement outcome measures of compliance.
Measured: Immediately after completion of the 8-week intervention
Adverse events associated with the DT-PLB intervention
In each DT-PLB session, the participants during the intervention will record whether they had any uncomfortable feelings
Measured: Immediately after completion of the 8-week intervention
Secondary outcomes (7)
mMRC Dyspnea Scale
The Modified Medical Research Council (mMRC) Dyspnea Scale consists of five categories, ranging from 0 to 4, with higher scores indicating more severe breathlessness. A score of 0 indicates no breathlessness during activities, while a score of 4 suggests breathlessness.
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
CAT scale
COPD assessment test (CAT)is a questionnaire-based tool that is commonly used to assess the impact of chronic obstructive pulmonary disease (COPD)on a patient's health status and quality of life. It consists of eight questions that cover a range of symptoms, including cough, sputum production, breathlessness, chest tightness, and activity limitations. Each question on the CAT is scored on a scale from 0 to 5, with a maximum possible score of 40. A higher score indicates a greater degree of symptom severity and a poorer health status.
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
The System Usability Scale
The system usability scale (SUS)is a standardized questionnaire that is used to evaluate the usability and user experience of a wide range of products, services, and systems. It produces a score between 0 and 100, with higher scores indicating better usability and user experience. The SUS has been validated and is widely used in both industry and research settings to evaluate the usability and user experience of a wide range of systems and products, including software applications, websites, and medical devices.
Measured: Immediately after completion of the 8-week intervention (T2)
Participants overall satisfaction
Participants will be required to rate their satisfaction with this software intervention, with a 10-point numeric rating scale (NRS) , where "1" represents "very dissatisfied" and "10" means "very satisfied".
Measured: Immediately after completion of the 8-week intervention (T2)
Six-minute-walking test
The Six-Minute Walk Test is a commonly used measure of functional exercise
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
Pulmonary function index:FEV1%predicted, FEV1/FVC
FEV1%predicted stands for "forced expiratory volume in one second predicted" and is a measure of lung function. It represents the maximum amount of air that a person can forcefully exhale from their lungs in one second. FEV1%predicted is expressed as a percentage of the predicted value for someone with the same characteristics who does not have lung disease.
FEV1/FVC is another measure of lung function, which represents the ratio of the amount of air that a person can forcefully exhale in one second (FEV1)to the total amount of air that they can exhale(forced vital capacity or FVC)over the course of a full exhalation. A low FEV1/FVC ratio indicates that the airways are obstructed or narrowed, which is a characteristic feature of COPD.
Measured: From baseline (T1) to the completion of the 8-week intervention (T2)
Health points obtained by each participant performing formulated operations
Health points are set based on consensus, obtained by operating actions on this software:
- Login: participants' stay on the software lasts for over one minute, they will earn one health point, with a maximum of three health points per day.
- Watch PLB health education video: For every minute participants stay on the video, they will earn one health point. The maximum score for a single viewing is equal to the length of the video.
- Accept PLB exercise task: Earning one health point upon claiming an exercise task. For every minute spent on the exercise animated videos, patients earn one health point, with a maximum of up to ten health points.
- Social forum: Participants can post an update in an internal forum, earning them one health point, with a maximum of three health points per day.
- Reward health points of consecutive accepted tasks: an additional rewarded 50 points for continuously claiming exercises tasks for 9 consecutive times.
Measured: Immediately after completion of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start30 Oct 2023 (estimated)
- Primary completion20 Apr 2024 (estimated)
- Study completion20 Apr 2024 (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 Pulmonary Disease, Chronic ObstructiveStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Houqiang Huang, Manchester Metropolitan University
- Investigators
- Houqiang Huang, Master, Principal investigator, Manchster Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063733
- Sponsor's protocol ID
- KY2023105
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang H, Liu F, Mohammad M, Watson R, Hayter M, Huang M, Li Z. Digital gamification-based pursed lip breathing exercises driven by Behaviour Change Wheel in patients with COPD: a feasibility trial protocol using pre-post study design. BMJ Open. 2025 Mar 27;15(3):e090832. doi: 10.1136/bmjopen-2024-090832.
PubMed 40147988
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD
- ClinicalTrials.gov ID
- NCT06063733
- Acronym / sponsor ID
- KY2023105
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pursed lip breathing, Behavioral interventions, Gamification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 2 Oct 2023 (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 goal of this pre-post design clinical trial is to develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones (DT-PLB) and to preliminarily evaluate its feasibility and effects in stable Chronic Obstructive Pulmonary Disease (COPD). The main objectives are:
- To develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones for managing breathing exercises in stable COPD patients.
- To pilot the methodological procedures of the pre-post study.
- To determine the recruitment rate, retention rate, attrition rate, and software usage compliance during the subject recruitment and follow-up process of the pre-post study.
- To evaluate the perception and satisfaction of COPD patients using the DT-PLB.
- To preliminarily examine the effects of using the DT-PLB intervention on COPD patients, including the six-minute walking test, FEV1% predicted, FEV1/FVC, mMRC scale, COPD assessment test scale, and health points.
- To identify any potential adverse events associated with the implementation of DT-PLB.
Participants will perform the following tasks during the intervention:
- Register a personal account on the DT-PLB software.
- Acquire knowledge and skills related to Pursed Lip Breathing by watching instructional videos.
- Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software.
- Earn health points by completing specific actions as instructed.
- Optionally post individual texts on the peer forum for peer support within the DT-PLB software.
- Complete two outcome assessments as scheduled.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital PLB intervention | Experimental | Other: Digital pursed lip breathing interventionParticipants will perform the following tasks during the intervention: 1. Register a personal account on the theory-based pursed lip breathing intervention protocol software system installed on smartphones(DT-PLB). 2. Acquire knowledge and skills related to pursed lip breathing by watching instructional videos. 3. Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software. 4. Earn health points by completing specific actions as instructed. 5. Optionally post individual texts on the peer forum for peer support within the DT-PLB software. 6. Complete two outcome assessments as scheduled. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with COPD satisfying GOLD criteria (Agusti, 2022) ;
- Being Chinese;
- Able to understand, speak, and hear;
- Clinically stable for at least three months prior to enrollment (Soler-Cataluna et al., 2018) ;
- The classification of GOLD grades for patients is mild, moderate, and severe, which means: FEV1/FVC<70%, FEV1>30%pre (Agusti, 2022) ;
Key exclusion criteria (3 listed)
- Impaired hand function causing inability to use the application;
- Have disorders in pleural effusion, pulmonary malignancy, heart diseases, stroke with sequels;
- Patients who have oral or nasal diseases cannot complete the exercise.
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 |
|---|---|---|
| Digital pursed lip breathing interventionAfter registration, participants will watch an educational video on the developed software, covering the definition, benefits, and techniques of pursed lip breathing. Following this, participants will engage in pursed lip breathing interventions, guided by voice and animated instructions from the software. These sessions will occur three times daily (morning, afternoon, and night) for 10 minutes each, lasting for 8 weeks. After each session, participants can choose to post texts on a peer social forum for peer support. Fellow participants can give 'comments' or 'likes'. The principal researcher will oversee texts, peer comments, removing information containing personal data, medical recommendations, and negative comments. Additionally, participants can earn health points by performing specific actions (e.g., watching the educational video and practicing pursed lip breathing) on the software, encouraging their participation in related activities. | Other | Digital PLB intervention |
Primary outcome
Recruitment rate
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of participants who participate in the study divided by the number of participants eligible for participation
Retention rate
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who complete the study divided by the number of subjects who participate in the study
Attrition rate
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who drop out after participation divided by the number of subjects who participate in the study
Software usage Compliance
Time frame: Immediately after completion of the 8-week intervention
The compliance rate is one of compliance outcomes, reflecting the level of patient engagement in the intervention. Overall compliance will be defined as the compliance averaged in all patients. Compliance rate = (actual number of participation in the intervention/planned number of sessions)x 100%. In addition, minutes-consuming recorded on the software for participants during the research will be used to complement outcome measures of compliance.
Adverse events associated with the DT-PLB intervention
Time frame: Immediately after completion of the 8-week intervention
In each DT-PLB session, the participants during the intervention will record whether they had any uncomfortable feelings
7 secondary outcomes
mMRC Dyspnea Scale
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
CAT scale
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
The System Usability Scale
Time frame: Immediately after completion of the 8-week intervention (T2)
Participants overall satisfaction
Time frame: Immediately after completion of the 8-week intervention (T2)
Six-minute-walking test
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
Pulmonary function index:FEV1%predicted, FEV1/FVC
Time frame: From baseline (T1) to the completion of the 8-week intervention (T2)
Health points obtained by each participant performing formulated operations
Time frame: Immediately after completion of the 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 40147988Huang H, Liu F, Mohammad M, Watson R, Hayter M, Huang M, Li Z. Digital gamification-based pursed lip breathing exercises driven by Behaviour Change Wheel in patients with COPD: a feasibility trial protocol using pre-post study design. BMJ Open. 2025 Mar 27;15(3):e090832. doi: 10.1136/bmjopen-2024-090832.
- 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.
Houqiang Huang, Master principal investigator
Manchster Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital pursed lip breathing intervention in people with Pulmonary Disease, Chronic Obstructive, run by Manchester Metropolitan University 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 6 inclusion and 3 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 2 Oct 2023. 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 Houqiang Huang, Master (+8618715799162, 21442584@stu.mmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From baseline (T1) to the completion of the 8-week intervention (T2)). The study lists 5 primary outcomes in all. 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 NCT06063733, 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 2 Oct 2023.