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Recruiting NCT07195838

Mindful-Breath for People With COPD

No phase Interventional Mindfulness Pulmonary Rehabilitation Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hybrid Mindfulness-Based Group Sessions, Ecological Momentary Interventions (EMI), Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group, Activity Monitoring.
Who it may be relevant to
Registry conditions: Mindfulness, Pulmonary Rehabilitation, Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Behavioral 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 vi
  • 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.
  • 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.
  • Device Activity Monitoring
    All participants will wear a wristband activity tracker to monitor their physical activity in daily life.

Primary outcome measures

  • 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)]
  • Acceptability in terms of instances of adverse events [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)]
  • Acceptability in terms of satisfaction with intervention [Time frame: T1 (immediate post-intervention)]
Secondary outcome measures (10)
  • Time spent on moderate-vigorous PA in the past week (min) [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)]
  • Self-reported PA in the past week [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).]
  • Pulmonary function [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).]
  • Perceived stress [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).]
  • Spiritual well-being [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).]
  • Symptom burden and HRQOL [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).]
  • Impact of COPD on daily life [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).]
  • Breathlessness [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).]
  • Cardiopulmonary functions [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).]
  • Exacerbation in the follow-up period [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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • School of Nursing, The University of Hong Kong, Hong Kong — Hong Kong

Identifiers

NCT: NCT07195838 · 22233241

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗