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

NCT06063733 | Unknown

• 1 other identifier: KY2023105
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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. 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. 2.To pilot the methodological procedures of the pre-post study.
3. 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. 4.To evaluate the perception and satisfaction of COPD patients using the DT-PLB.
5. 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. 6.To identify any potential adverse events associated with the implementation of DT-PLB.
7. 7.Register a personal account on the DT-PLB software.
8. 8.Acquire knowledge and skills related to Pursed Lip Breathing by watching instructional videos.
9. 9.Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software.
10. 10.Earn health points by completing specific actions as instructed.
11. 11.Optionally post individual texts on the peer forum for peer support within the DT-PLB software.
12. 12.Complete two outcome assessments as scheduled.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pursed lip breathing; Behavioral interventions; Gamification

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  The number of participants who participate in the study divided by the number of participants eligible for participation

  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

  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

  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.

  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

  Immediately after completion of the 8-week intervention

Secondary Outcomes (7)

• mMRC Dyspnea Scale

  From baseline (T1) to the completion of the 8-week intervention (T2)

• CAT scale

  From baseline (T1) to the completion of the 8-week intervention (T2)

• The System Usability Scale

  Immediately after completion of the 8-week intervention (T2)

• Participants overall satisfaction

  Immediately after completion of the 8-week intervention (T2)

• Six-minute-walking test

  From baseline (T1) to the completion of the 8-week intervention (T2)

Study Arms (1)

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.

Other: Digital pursed lip breathing intervention

Interventions

Digital pursed lip breathing intervention 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.

Digital PLB intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Related Publications (1)

• 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.

  PMID: 40147988 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Houqiang Huang, Master

  Manchster Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Houqiang Huang, Master

CONTACT

+8618715799162; 21442584@stu.mmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A postgraduate researcher in the School of Nursing & Public Health

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 2, 2023
• Study Start: October 30, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)