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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
School of Nursing, The University of Hong Kong, Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Jojo Yan Yan Kwok
jojoyyk@hku.hk
85239176644
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 60
Treatments
Experimental: Intervention: hybrid mindfulness-based pulmonary rehabilitation and lifestyle modification group
(i) 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.~(ii) Ecological Momentary Interventions (EMI):Personalised mindfulness-based lifestyle counselling through instant messages with chat-based support throughout the 8-week intervention period.~(iii) Activity Monitoring: All participants will wear a wristband activity tracker to monitor their physical activity in daily life.
Active_comparator: Control: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group
(i) 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, and will only receive reminder messages for follow-ups. (ii) Activity Monitoring: All participants will wear a wristband activity tracker to monitor their physical activity in daily life.
Sponsors
Leads: The University of Hong Kong
Collaborators: Health and Medical Research Fund

This content was sourced from clinicaltrials.gov