NCT06063733

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

Status unknown NA Last updated 2 October 2023

What this trial tests

NA trial testing Digital pursed lip breathing intervention in Pulmonary Disease, Chronic Obstructive in 15 participants. Status unknown.

Timeline

30 October 2023

Primary endpoint
20 April 2024

20 April 2024

Quick facts

Lead sponsor	Manchester Metropolitan University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	30 October 2023
Primary completion	20 April 2024
Estimated completion	20 April 2024
Sites	1 location across China

Drugs / interventions tested

• Digital pursed lip breathing intervention

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

Manchester Metropolitan University

Who can join

Eligibility, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Huang H, Liu F, Mohammad M, Watson R, et al · · 2025 · PMID 40147988 · DOI 10.1136/bmjopen-2024-090832