RecruitingNot ApplicableNCT07195838

Mindful-Breath for People With COPD

Effects of a Hybrid, Personalised Mindfulness-optimised Pulmonary Rehabilitation (Mindful-Breath) Programme for Active Living for People With Chronic Obstructive Pulmonary Disease: A Pilot Randomised Controlled Trial


Sponsor

The University of Hong Kong

Enrollment

60 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Individuals living with chronic obstructive pulmonary disease (COPD) often suffer from stress and behavioral risks such as physical inactivity. In an attempt to promote healthy behaviors and overall wellbeing among this particular population, this study aims to develop and evaluate a personalized Mindful-Breath intervention combining telehealth technology and mindfulness for COPD patients. This is an assessor-blinded, two-arm exploratory randomized controlled trial with a sequential mixed-method design. A total of 60 participants will be recruited and randomly assigned to either intervention or control group using 1:1 ratio. Intervention group will go through 8 weekly 60-min hybrid group sessions, combining mindfulness-based pulmonary rehabilitation and lifestyle modification. Personalized mindfulness-based lifestyle counselling through instant messages with chat-based support throughout the 8-week intervention period will also be provided. Control group will receive a single in-person 60-min group session on general education on pulmonary rehabilitation and lifestyle modification and will only receive reminder messages for follow-ups. Variables such as time spent on physical activity, lung function, perceived stress, symptom burden and health-related quality of life will be collected at three time-points (T0: baseline, prior to randomization; T1: immediate post-intervention; T2: 3-month post-intervention).


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial (Mindful-Breath) is testing whether a mindfulness-based breathing app can reduce stress and improve quality of life and lung function in people with chronic obstructive pulmonary disease (COPD) who are experiencing moderate stress. **You may be eligible if...** - You are between 50 and 80 years old - You have been diagnosed with COPD (with lung function confirming airflow obstruction) - Your COPD is stage I to IV and classified as Group B or E by 2024 GOLD guidelines - You have not had a COPD flare-up (exacerbation) in the past 4 weeks - Your stress score is 14 or above on the Perceived Stress Scale - You have a smartphone, tablet, or laptop with internet access - You can read, communicate, and provide consent in Chinese **You may NOT be eligible if...** - You already exercise more than 60 minutes per week at moderate intensity - You have had a recent COPD exacerbation in the past 4 weeks (you can be rescreened later) - You do not have internet access or a compatible device - Your stress score is below 14 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHybrid Mindfulness-Based Group Sessions

Eight 60-min hybrid group sessions, combining mindfulness-based pulmonary rehabilitation and lifestyle modification. The sessions cover topics such as the eight yoga's ethical guidelines (yamas and niyamas) for positive lifestyle behaviors, breathing mechanisms, dysfunctional breathing styles, voluntary control of breathing (pranayama), relaxation and sense withdrawal (pratyahara), concentration (dharana), meditation (dhyana), and enlightenment (samadhi). Subsequent sessions will be delivered via videoconferencing using Zoom and will include guided breathing-focused practices.

BEHAVIORALEcological Momentary Interventions (EMI)

Personalised mindfulness-based lifestyle counselling through instant messages with chat-based support throughout the 8-week intervention period. The intervention protocol will cover message content library, regular message delivery and personalised chat-based support.

BEHAVIORALSingle General Education on Pulmonary Rehabilitation and Lifestyle Modification Group

The control group participants will receive a single in-person 60-min group session on general education on pulmonary rehabilitation and lifestyle modification based on the GOLD 2024 teaching set and HEARTS technical package for NCD prevention as recommended by the WHO.

DEVICEActivity Monitoring

All participants will wear a wristband activity tracker to monitor their physical activity in daily life.


Locations(1)

School of Nursing, The University of Hong Kong, Hong Kong

Hong Kong, Hong Kong

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NCT07195838


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