NCT06063733

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Manchester Metropolitan University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-04-20
• Completion: 2024-04-20
• First posted: 2023-10-02
• Last updated: 2023-10-02

Locations

1 site across 1 country: China