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 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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Progressive Walking Exercise Programme

    Other intervention

    Participants 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

    Behavioral

    Real-time air quality information and guidance provided by the online platform.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Air Quality Information ProvidedExperimental treatment 2 interventions
Group B: Air Quality Information Not ProvidedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1-week baseline and weekly throughout the 12 week intervention
2

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.

Time frame
1-week baseline and weekly throughout the 12 week intervention
3

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.

Time frame
1-week baseline and weekly throughout the 12 week intervention

Secondary 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
1-week baseline and weekly throughout the 12-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: