Mindful-Breath for People With COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorThe University of Hong Kong
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid Mindfulness-Based Group Sessions
BehavioralEight 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)
BehavioralPersonalised 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 Group
BehavioralThe 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
DeviceAll participants will wear a wristband activity tracker to monitor their physical activity in daily life.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention: hybrid mindfulness-based pulmonary rehabilitation and lifestyle modification groupExperimental treatment 3 interventions
Group B: Control: Single General Education on Pulmonary Rehabilitation and Lifestyle Modification GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
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.
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)2
Acceptability in terms of instances of adverse events
Instances of adverse events (information regarding physical and psychological problems will be kept)
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)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
Time frame
T1 (immediate post-intervention)Secondary outcomes
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
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)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.
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).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.
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).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.
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).Sponsors and contacts
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The University of Hong Kong
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov