RecruitingNot Applicable

Mindful-Breath for People With COPD

Hong Kong60 participantsStarted 2025-09-30

Plain-language 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).

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 50-80 years * Sex: Male or female * Education level: Primary or above * Diagnosis: COPD (Baseline FEV1 \<80% and FEV1/FVC \<70% of predicted normal values) * Severity of COPD: Stage I to IV * Group of COPD: Group B, or E, based on 2024 GOLD guideline (36) * Clinical stability: No acute exacerbation in the past 4 weeks. Patients with recent acute exacerbation in the past 4 weeks will be screened again in subsequent follow-up. * Moderate stress: PSS score ≥14 (28) * Access to a mobile device (e.g., a smartphone, tablet, or laptop) with internet connectivity * Ability to read, communicate, and provide written consent in Chinese. Exclusion Criteria: * Engaging in \>60 minutes/week of moderate PA based on American Lung Association guidelines * Recent or ongoing receipt of other pharmacological/behavioral trials within the past 3 months * Contraindications or severe comorbidities that may limit full participation (mental diseases, deafness, limb activity disorder, coronary heart disease, arterial aneurysm, uncontrolled hypertension, pregnancy, etc) * Co-existing respiratory diseases (Asthma/interstitial lung disease/bronchiectasis) or active malignancies * Very severe COPD requiring long-term oxygen therapy or home non-invasive ventilation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is described as 'Phase NA,' which usually means it's a very early feasibility study rather than a full clinical trial — does that mean there's limited safety and effectiveness data on this mindfulness-breathing program for COPD, and what does that mean for me personally if I were to consider it?
2Since the trial is measuring whether people actually stick with the program and whether it causes any adverse events, what kinds of risks or side effects should I be aware of when combining mindfulness techniques with my current COPD management?
3Given that this study is focused on testing whether the program is even practical and acceptable rather than proving it works, would you recommend I also continue with — or prioritize — standard pulmonary rehabilitation alongside exploring this trial?
4The trial is actively recruiting right now, so what would participating actually involve day-to-day — how much time, how often, and in what format — and would those demands realistically fit my current health situation and lifestyle?
5Are there aspects of my specific COPD severity, medications, or other conditions that might make me a poor fit for a mindfulness-based breathing intervention, and is this something worth discussing with a respiratory specialist before I look into it further?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility in terms of rates of recruitment, retention and adherence

Timeframe: Repeated outcome measures will be collected at three time-points (T0:baseline, prior to randomisation; T1: immediate post-intervention; T2: 3-month post-intervention)

Acceptability in terms of instances of adverse events

Timeframe: Repeated outcome measures will be collected at three time-points (T0:baseline, prior to randomisation; T1: immediate post-intervention; T2: 3-month post-intervention)

Acceptability in terms of satisfaction with intervention

Timeframe: T1 (immediate post-intervention)

Trial details

NCT IDNCT07195838

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-30

Contact for this trial

Jojo Yan Yan Kwok

85239176644 jojoyyk@hku.hk

View on ClinicalTrials.gov More Mindfulness trials

Plain-language summary

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility in terms of rates of recruitment, retention and adherence

Timeframe: Repeated outcome measures will be collected at three time-points (T0:baseline, prior to randomisation; T1: immediate post-intervention; T2: 3-month post-intervention)

Acceptability in terms of instances of adverse events

Timeframe: Repeated outcome measures will be collected at three time-points (T0:baseline, prior to randomisation; T1: immediate post-intervention; T2: 3-month post-intervention)

Acceptability in terms of satisfaction with intervention

Timeframe: T1 (immediate post-intervention)