Mindful-Breath for People With COPD

Официальное название

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

Обзор

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).

Вмешательства

• Поведенческое 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
• Поведенческое 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.
• Поведенческое 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.
• Устройство Activity Monitoring
  All participants will wear a wristband activity tracker to monitor their physical activity in daily life.

Первичные конечные точки

• Feasibility in terms of rates of recruitment, retention and adherence [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T1 (immediate post-intervention)]

Вторичные конечные точки (10)

• Time spent on moderate-vigorous PA in the past week (min) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Repeated outcome measures will be collected at three time-points (T0:baseline, prior to randomisation; T1: immediate post-intervention; T2: 3-month post-intervention).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 1 центр

• School of Nursing, The University of Hong Kong, Hong Kong — Гонконг

Идентификаторы

NCT: NCT07195838 · 22233241

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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