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

Manchester Metropolitan University

Status: Not yet enrolling

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Digital pursed lip breathing intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06063733

KY2023105

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Digital PLB intervention

Experimental group

Description:

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.

Treatment:

Other: Digital pursed lip breathing intervention