Clinical trial NCT06063733: Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD
Official title: Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pursed lip breathing
Behavioral interventions
Gamification
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Recruitment rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Retention rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Attrition rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Software usage Compliance
timeFrame: Immediately after completion of the 8-week intervention
measure: Adverse events associated with the DT-PLB intervention
timeFrame: Immediately after completion of the 8-week intervention
Secondary outcomes:
measure: mMRC Dyspnea Scale
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: CAT scale
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: The System Usability Scale
timeFrame: Immediately after completion of the 8-week intervention (T2)
measure: Participants overall satisfaction
timeFrame: Immediately after completion of the 8-week intervention (T2)
measure: Six-minute-walking test
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Pulmonary function index:FEV1%predicted, FEV1/FVC
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Health points obtained by each participant performing formulated operations
timeFrame: Immediately after completion of the 8-week intervention
Other outcomes:
Locations:
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
Study officials:
affiliation: Manchster Metropolitan University
name: Houqiang Huang, Master
role: PRINCIPAL_INVESTIGATOR
References: