Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD

NCT ID: NCT06063733

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2024-04-20

Brief 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). The main objectives are:

1. To develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones for managing breathing exercises in stable COPD patients.

2. To pilot the methodological procedures of the pre-post study.

3. 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.

4. To evaluate the perception and satisfaction of COPD patients using the DT-PLB.

5. 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.

6. To identify any potential adverse events associated with the implementation of DT-PLB.

Participants will perform the following tasks during the intervention:

1. Register a personal account on the DT-PLB software.

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Digital PLB intervention

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.

Group Type: EXPERIMENTAL

Digital pursed lip breathing intervention

Intervention Type: OTHER

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.

Interventions

Digital pursed lip breathing intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Houqiang Huang

A postgraduate researcher in the School of Nursing & Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Houqiang Huang, Master

Role: PRINCIPAL_INVESTIGATOR

Manchster Metropolitan University

Locations

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Countries

China

Central Contacts

Houqiang Huang, Master

Role: CONTACT

21442584@stu.mmu.ac.uk

+8618715799162

Facility Contacts

Houqiang Huang, Master

Role: primary

21442584@stu.mmu.ac.uk

+8618715799162

References

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.

Reference Type: DERIVED

PMID: 40147988 (View on PubMed)

Other Identifiers

KY2023105

Identifier Type: -

Identifier Source: org_study_id