About this trial
The primary objective of EPIC-AIR is to evaluate the feasibility and potential effectiveness of integrating real-time air pollution monitoring into cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) programmes via an online platform that delivers both exercise prescription and air pollution guidance. Specific objectives are: (1) to determine whether access to real-time air quality data reduces modelled ambient pollution exposure (PM2.5, PM10 and NO2) during outdoor physical activity in CR/PR patients and healthy volunteers; (2) to assess the feasibility of the trial design, including recruitment, randomisation, retention, adherence and completeness of outcome data; (3) to measure the impact of the intervention on physical activity levels, health-related quality of life and cardiovascular biomarkers; and (4) to inform the design and sample size of a future definitive randomised controlled trial
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cohort A: Patients with long-term conditions Inclusion criteria for Cohort A are: male or female adults aged ≥18 years; clinical diagnosis of one or more of asthma, COPD, interstitial lung disease (ILD), coronary heart disease (CHD), or heart failure (HF), and signed off for exercise rehabilitation by a clinician; ownership of a GPS-enabled smartphone with internet access; ability to walk outdoors for a minimum of 5 minutes without feeling uneasy or unsteady; availability to complete the 1-week baseline period, 12-week intervention and 3-month post-intervention follow-up within the planned study period; willingness and ability to give informed consent; and willingness to wear a Fitbit device for >70% of the study duration.
Inclusion criteria for Cohort B are identical to Cohort A, with the exception that participants must have no diagnosis of asthma, COPD, ILD, CHD, or HF.
Disqualifiers
Exclusion criteria for both cohorts are: diagnosis of dementia, learning disability, severe mental health disorders (excluding depression or anxiety), or epilepsy; receiving palliative care; insufficient English language ability to understand study documentation and use the platform; having been advised not to exercise by a healthcare professional within the past 12 months; currently pregnant; presence of chest pain at rest; and marked unsteadiness when standing or walking.
Trial design
Parallel
Treatments tested in this trial
Progressive Walking Exercise Programme
Other interventionParticipants will receive a progressive, personalised walking exercise programme aimed to increase their weekly levels of physical activity over a 12 week study period.
Real-time air quality information and guidance
BehavioralReal-time air quality information and guidance provided by the online platform.
Treatment groups
Trial outcomes
Primary outcomes
Weekly time-weighted mean modelled ambient PM2.5 concentration during moderate-to-vigorous physical activity
Time-stamped GPS/GNSS locations recorded by the P-STEP platform during Fitbit-derived moderate-to-vigorous physical activity (MVPA) will be linked to contemporaneous modelled ambient PM2.5 concentration estimates. Concentrations will be time-weighted across eligible MVPA periods to derive a weekly mean ambient PM2.5 concentration for each participant.
Weekly time-weighted mean modelled ambient PM10 concentration during moderate-to-vigorous physical activity
Time-stamped GPS/GNSS locations recorded by the P-STEP platform during Fitbit-derived moderate-to-vigorous physical activity (MVPA) will be linked to contemporaneous modelled ambient PM10 concentration estimates. Concentrations will be time-weighted across eligible MVPA periods to derive a weekly mean ambient PM10 concentration for each participant.
Weekly time-weighted mean modelled ambient NO2 concentration during moderate-to-vigorous physical activity
Time-stamped GPS/GNSS locations recorded by the P-STEP platform during Fitbit-derived moderate-to-vigorous physical activity (MVPA) will be linked to contemporaneous modelled ambient NO2 concentration estimates. Concentrations will be time-weighted across eligible MVPA periods to derive a weekly mean ambient NO2 concentration for each participant.
Secondary outcomes
Weekly physical activity (weekly minutes, measured by wrist-worn accelerometry)
Mean minutes of moderate to vigorous physical activity measured continuously over the 12-week intervention period using a wrist-worn accelerometer. The comparison will be change from baseline in mean weekly minutes between the air quality information and control arms at 12 weeks.
Sponsors and contacts
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