Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leicester
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 CR and 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 personal pollution exposure (PM2.5, PM10, NO2) during outdoor physical activity in CR/PR patients and healthy volunteers; (2) to evaluate the usability and acceptability of the platform in a clinical rehabilitation context; (3) to assess the feasibility of the trial design, including recruitment, randomisation, retention, and adherence rates; (4) to measure the impact of the intervention on physical activity levels, health-related quality of life, and cardiovascular biomarkers; and (5) 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 13-week intervention within the recruitment window (February-May 2026); 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
Design model
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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Air Quality Information ProvidedExperimental treatment 1 intervention
Group B: Air Quality Information Not ProvidedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ambient air pollution exposure per minute of physical activity (µg/m³ per minute of moderate-to-vigorous physical activity per week)
Mean ambient PM₂.₅ and NO₂ exposure per minute of moderate-to-vigorous physical activity (MVPA) per week, calculated by integrating real-time local air quality data with wrist-worn accelerometer-derived MVPA minutes . The primary comparison will be change from baseline in pollution exposure per minute of MVPA between the air quality information arm and the active comparator arm at 12 weeks.
Time frame
Baseline to 12 weeksSecondary outcomes
1
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.
Time frame
Baseline to 12 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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