Mindful-Breath for People With COPD

NCT07195838 | Recruiting DMC

• 1 other identifier: 22233241
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

mindfulness; pulmonary rehabilitation; chronic obstructive pulmonary disease; RCT; lifestyle modification; mHealth; EMI; physical inactivity

Outcome Measures

Primary Outcomes (3)

• Feasibility in terms of rates of recruitment, retention and adherence

  The feasibility of interventions will be evaluated in terms of rates of recruitment, retention, and adherence. Reasons for these rates will be recorded.

  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

  Instances of adverse events (information regarding physical and psychological problems will be kept)

  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

  Satisfaction with intervention will be measured by a questionnaire rating on four key domains: usefulness of treatment, opinion of the therapist, perceived improvement and likelihood to recommend the treatment to others

  T1 (immediate post-intervention)

Secondary Outcomes (10)

• Time spent on moderate-vigorous PA in the past week (min)

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

• Self-reported PA in the past week

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

• Pulmonary function

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

• Perceived stress

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

• Spiritual well-being

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

Study Arms (2)

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

EXPERIMENTAL

(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.

Behavioral: Hybrid Mindfulness-Based Group Sessions; Behavioral: Ecological Momentary Interventions (EMI); Device: Activity Monitoring

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

ACTIVE COMPARATOR

(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.

Behavioral: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group; Device: Activity Monitoring

Interventions

Hybrid Mindfulness-Based Group Sessions BEHAVIORAL

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.

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

Ecological Momentary Interventions (EMI) BEHAVIORAL

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.

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

Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group BEHAVIORAL

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.

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

Activity Monitoring DEVICE

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

Control: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group; Intervention: hybrid mindfulness-based pulmonary rehabilitation and lifestyle modification group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sedentary Behavior

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Jojo Yan Yan Kwok

CONTACT

85239176644; jojoyyk@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: September 29, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)