Mindful-Breath for People With COPD

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Mindfulness; Pulmonary Rehabilitation; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Activity Monitoring; Behavioral: Hybrid Mindfulness-Based Group Sessions; Behavioral: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group; Behavioral: Ecological Momentary Interventions (EMI)

Study type: Interventional

Funder types: Other

Identifiers

NCT07195838

22233241

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention: hybrid mindfulness-based pulmonary rehabilitation and lifestyle modification group

Experimental group

Description:

(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.

Treatment:

Behavioral: Ecological Momentary Interventions (EMI)

Behavioral: Hybrid Mindfulness-Based Group Sessions

Device: Activity Monitoring

Control: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group

Active Comparator group

Description:

(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.

Treatment:

Behavioral: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group

Device: Activity Monitoring