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MindfulnessNCT07195838

Mindful-Breath for People With COPD

A study testing Hybrid Mindfulness-Based Group Sessions, Ecological Momentary Interventions (EMI) and Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group in people with Mindfulness and Pulmonary Rehabilitation, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
Hybrid Mindfulness-Based Group Sessions, Ecological Momentary Interventions (EMI) and Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHong Kong
Study dates
30 Sep 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jojo Yan Yan Kwok contact

85239176644

jojoyyk@hku.hk

Hong Kong1 site, 1 recruiting
  • School of Nursing, The University of Hong Kong, Hong Kong

    Hong Kong

    Jojo Yan Yan Kwok, 85239176644, jojoyyk@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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

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).

Being tested
Hybrid Mindfulness-Based Group Sessions, Ecological Momentary Interventions (EMI), Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group, Activity Monitoring
Keywords
mindfulness, pulmonary rehabilitation, chronic obstructive pulmonary disease, RCT, lifestyle modification, mHealth, EMI, physical inactivity
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hybrid Mindfulness-Based Group SessionsBehavioural

    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.

  • Ecological Momentary Interventions (EMI)Behavioural

    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.

  • Single General Education on Pulmonary Rehabilitation and Lifestyle Modification GroupBehavioural

    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.

  • Activity MonitoringDevice

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

Study groups in NCT07195838
Study groupRoleWhat they receive
Intervention: hybrid mindfulness-based pulmonary rehabilitation and lifestyle modification groupExperimental(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.
Receives: Behavioral: Hybrid Mindfulness-Based Group Sessions; Behavioral: Ecological Momentary Interventions (EMI); Device: Activity Monitoring
Control: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification GroupActive 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.
Receives: Behavioral: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group; Device: Activity Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Acceptability in terms of instances of adverse events

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

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

  3. 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

    Measured: T1 (immediate post-intervention)

Secondary outcomes (10)
  1. Time spent on moderate-vigorous PA in the past week (min)

    Time spent on moderate-vigorous PA in the past week (min) measured by a smartwatch. The data will be considered valid if the participants wear the smartwatch for ≥10 hours/days for ≥5 days in the past week of assessment time-point

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

  2. Self-reported PA in the past week

    Self-reported PA in the past week will be measured by the validated 9-item International Physical Activity Questionnaire Short-form (IPAQ-SF)(Chinese), which records four intensity PA levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.

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

  3. Pulmonary function

    Pulmonary function will be evaluated using portable spirometry. The assessment includes measuring forced expiratory volume in 1s (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), and oxygen saturation (SaO2). The highest value for FEV1, FVC, and EFV1/FVC (Tiffeneau-Pinelli index) from three reproducible efforts will be recorded.

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

  4. Perceived stress

    Perceived stress will be measured by the validated 10-item Perceived Stress Scale (PSS)(Chinese)(Cronbach's α: 0.78-0.91). The event frequency of each item in the last month will be rated using a five-point Likert scale. Higher scores indicate higher perceived stress levels.

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

  5. Spiritual well-being

    Spiritual well-being measured by the validated Chinese Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12-Item Scale (FACIT-Sp-12), which assess three constructs: belief, meaning and sense of peace on a 4-point Likert scale. High scores indicate high levels of spiritual well-being.

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

  6. Symptom burden and HRQOL

    Symptom burden and HRQOL will be measured by the validated disease-specific 50-item St. George's Respiratory Questionnaire (SGRQ)(Chinese), which assesses three domains: frequency and severity of respiratory symptoms, effects of breathlessness on mobility and PA, and psychosocial impact of the disease. Scores are weighted such that every domain score and the total score range from 0-100. Higher scores indicate a poorer HRQOL. The minimally clinically important response to treatment is defined as an improvement of 4% on the separate domains and the total score.

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

  7. Impact of COPD on daily life

    Impact of COPD on daily life will be measured by the COPD Assessment Test (CAT). This patient-completed questionnaire evaluates the overall effect of COPD-specifically symptoms such as cough, sputum, dyspnea, and chest tightness-on health status. CAT scores range from 0 to 40, with higher scores indicating a more severe impact of COPD on a patient's life. A five-unit difference in scores distinguishes stable patients from those experiencing exacerbations.

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

  8. Breathlessness

    Breathlessness will be measured by the modified Medical Research Council (mMRC) Dyspnoea scale. The mMRC scale is a self-assessment tool used to measure the level of impairment caused by breathlessness during daily activities, rated on a scale from 0 (no breathlessness except on strenuous exercise) to 4 (too breathless to leave the house, or breathless when dressing or undressing).

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

  9. Cardiopulmonary functions

    Cardiopulmonary functions will be assessed through the 6-minute walk test, where distance walked, oxygen saturation (SpO2), and heart rate will be measured.

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

  10. Exacerbation in the follow-up period

    Exacerbation in the follow-up period will be recorded to better to understand the frequency and severity of COPD exacerbations, contributing to a comprehensive understanding of disease management and progression.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start30 Sep 2025
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195838
Sponsor's protocol ID
22233241
Status last verified
Jun 2026
First submitted
23 Jun 2025
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data supporting the findings of this study are available upon request from the principal investigator, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid Mindfulness-Based Group Sessions, Ecological Momentary Interventions (EMI) and Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group in people with Mindfulness and Pulmonary Rehabilitation, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jojo Yan Yan Kwok (85239176644, jojoyyk@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility in terms of rates of recruitment, retention and adherence (time frame: Repeated outcome measures will be collected at three time-points (T0:baseline, prior to randomisation; T1: immediate post-intervention; T2: 3-month post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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