Mindfulness and Breathing Program for People With COPD

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 80 with stable COPD and moderate stress, who have a mobile device with internet and read Chinese.

Age

50 to 80 years

Sex

Men and women

Disease stage

COPD stage I to IV, group B or E (2024 GOLD guideline), with FEV1 under 80% and FEV1/FVC under 70% of predicted values; no flare-up in the past 4 weeks; stress score (PSS) of 14 or more

Earlier treatment

Cannot have joined other drug or behavioral trials in the past 3 months

Main reasons for not taking part

• More than 60 minutes a week of moderate physical activity
• Other lung diseases (asthma, interstitial lung disease, bronchiectasis) or active cancer
• Very severe COPD needing long-term oxygen or home non-invasive ventilation
• Severe other conditions that limit taking part (e.g. mental illness, deafness, coronary heart disease, uncontrolled high blood pressure, pregnancy)
• Other drug or behavioral trial in the past 3 months

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 50 and 80 years old?YesNo

What the trial wants to find out

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).

The 2 groups in the trial

• Intervention: hybrid mindfulness-based pulmonary rehabilitation and lifestyle modification groupTreatment being tested

  (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: Hybrid Mindfulness-Based Group Sessions, Ecological Momentary Interventions (EMI), and Activity Monitoring

• Control: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification GroupExisting treatment, for comparison

  (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: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification Group and Activity Monitoring