Actively Recruiting
Effects of a Hybrid, Personalized Mindfulness-Optimized Pulmonary Rehabilitation Program for Active Living in People With Chronic Obstructive Pulmonary Disease: A Pilot Randomized Controlled Trial
Led by The University of Hong Kong · Updated on 2025-09-29
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Hong Kong
Lead Sponsor
H
Health and Medical Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized Mindful-Breath intervention designed to improve healthy behaviors and overall well-being in people living with chronic obstructive pulmonary disease (COPD). This assessor-blinded, randomized controlled trial will include 60 participants who have moderate stress and meet specific COPD criteria. The study aims to assess the feasibility, acceptability, and impact of combining mindfulness with pulmonary rehabilitation and lifestyle changes. Participants assigned to the intervention group will attend eight weekly 60-minute hybrid group sessions that blend mindfulness-based pulmonary rehabilitation with lifestyle modification. These sessions cover topics like yoga ethics, breathing techniques, meditation, and relaxation, delivered partly via videoconferencing. They will also receive personalized mindfulness-based lifestyle counseling through instant messages with chat support during the 8-week intervention. The control group will have a single in-person 60-minute session focused on general pulmonary rehabilitation education and lifestyle advice, plus reminder messages. All participants will wear a wristband activity tracker to monitor physical activity throughout the study. Participants will be assessed at three time points: before randomization (baseline), immediately after the 8-week intervention, and three months post-intervention. Researchers will collect data on physical activity levels, lung function, perceived stress, symptom burden, spiritual well-being, and health-related quality of life. The study will also monitor recruitment and retention rates, adherence, satisfaction, and any adverse events. The trial is led by The University of Hong Kong and will run until May 2027.
CONDITIONS
Brief Title
Mindful-Breath for People With COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 to 80 years
- Male or female
- Education level of primary school or above
- Diagnosed with COPD with baseline FEV1 <80% and FEV1/FVC <70% of predicted normal values
- COPD severity from Stage I to IV
- COPD group B or E as per 2024 GOLD guideline
- Clinically stable with no acute exacerbation in the past 4 weeks
- Moderate stress with PSS score ≥14
- Access to a mobile device with internet (smartphone, tablet, or laptop)
- Ability to read, communicate, and provide written consent in Chinese
You will not qualify if you...
- Engaging in more than 60 minutes per week of moderate physical activity
- Participation in other pharmacological or behavioral trials within the past 3 months
- Severe comorbidities or contraindications limiting participation (including mental diseases, deafness, limb disorders, coronary heart disease, arterial aneurysm, uncontrolled hypertension, pregnancy)
- Having other respiratory diseases such as asthma, interstitial lung disease, or bronchiectasis, or active cancers
- Very severe COPD requiring long-term oxygen therapy or home ventilation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either eight 60-minute hybrid mindfulness-based pulmonary rehabilitation sessions including lifestyle modification and guided breathing practices delivered partly via videoconferencing, along with personalized mindfulness-based lifestyle counselling through instant messages over 8 weeks; or a single in-person 60-minute general education session on pulmonary rehabilitation and lifestyle modification. All participants wear a wristband activity tracker to monitor their physical activity during this period.
8 hybrid group sessions and continuous messaging support for intervention group; 1 single group session for control group
Duration - 3 months
Participants are assessed for outcomes including physical activity, pulmonary function, stress, quality of life, and COPD impact at immediate post-intervention and 3 months after intervention completion.
2 visits (immediate post-intervention and 3 months post-intervention)
Trial Site Locations
Total: 1 location
1
School of Nursing, The University of Hong Kong, Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
J
Jojo Yan Yan Kwok
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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