Mindful-Breath for People With COPD

NCT ID: NCT07195838

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2027-05-30

Brief Summary

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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).

Detailed Description

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Conditions

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Mindfulness Pulmonary Rehabilitation Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Hybrid Mindfulness-Based Group Sessions

Intervention Type 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.

Ecological Momentary Interventions (EMI)

Intervention Type 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.

Activity Monitoring

Intervention Type 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

(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.

Group Type ACTIVE_COMPARATOR

Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group

Intervention Type 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.

Activity Monitoring

Intervention Type DEVICE

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

Interventions

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Hybrid Mindfulness-Based Group Sessions

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 Type BEHAVIORAL

Ecological Momentary Interventions (EMI)

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 Type BEHAVIORAL

Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group

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.

Intervention Type BEHAVIORAL

Activity Monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health and Medical Research Fund

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Kwok Yan Yan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Jojo Yan Yan Kwok

Role: CONTACT

85239176644

Facility Contacts

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Jojo Yan Yan Kwok

Role: primary

85239176644

Other Identifiers

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22233241

Identifier Type: -

Identifier Source: org_study_id

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