Cardiovascular DiseaseEPIC-AIRNCT07500948
Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation
A study testing Progressive Walking Exercise Programme and Real-time air quality information and guidance in people with Cardiovascular Disease and Asthma, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Asthma, COPD
- What is being tested?
- Progressive Walking Exercise Programme and Real-time air quality information and guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Glenfield Hospital, University Hospitals of Leicester NHS Trust, Groby Road
Leicester, Leicestershire, LE39QP
James Donaldson, Ph.D, 0300 303 1573, jad72@leicester.ac.uk
About this study
Official title: Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation (EPIC-AIR)
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
Read the detailed description
EPIC-AIR is a single-site, stratified, blinded, two-arm randomised controlled feasibility trial conducted at University Hospitals of Leicester NHS Trust. Up to 80 participants comprising cardiac rehabilitation patients, pulmonary rehabilitation patients and healthy volunteers will be recruited. Following a 1-week baseline monitoring period, participants will be stratified by participant group (cardiac rehabilitation, pulmonary rehabilitation or healthy volunteer) and randomised 1:1 within strata using a computer-generated allocation sequence via the Sealed Envelope secure web-based system.
All participants will receive a Fitbit Charge 6 and a 12-week progressive walking programme delivered through the P-STEP platform. Participants allocated to the intervention arm will additionally receive real-time local PM2.5, PM10 and NO2 information and adaptive guidance concerning the timing, location, route or intensity of outdoor activity. Participants in the control arm will use the same platform and receive the same exercise guidance but without air-quality information or pollution-related guidance.
The primary outcomes are three co-primary pollutant-specific measures: weekly time-weighted mean modelled ambient PM2.5, PM10 and NO2 concentrations during moderate-to-vigorous physical activity (MVPA). Time-stamped GPS locations recorded during activity will be linked to wearable-derived activity data and contemporaneous modelled air-quality concentrations. These outcomes represent modelled ambient concentrations encountered during recorded activity rather than directly measured personal inhaled dose.
Weekly pollution exposure during the 12-week intervention will be analysed using repeated-measures mixed-effects models accounting for participant clustering, baseline exposure, study week, randomisation stratum, sex and calendar week. The principal treatment contrast will be the adjusted average intervention-control difference across the 12-week post-allocation period. Multiplicity across the three co-primary pollutants will be controlled using the Holm procedure.
The registered secondary outcome is weekly physical activity derived from wrist-worn accelerometry. Additional clinical, physiological and patient-reported outcomes will be explored. Feasibility outcomes include recruitment, retention, adherence, completeness of outcome data and adverse events. A final follow-up assessment will take place 3 months after completion of the 12-week intervention. No participants had been recruited at the time the registry record was revised.
- Conditions
- Cardiovascular Disease, Asthma, COPD, Interstitial Lung Disease Due to Systemic Disease, Heart Failure, Coronary Heart Disease (CHD)
- Being tested
- Progressive Walking Exercise Programme, Real-time air quality information and guidance
- Keywords
- air pollution, cardiac rehabilitation, exercise
- Medical subject headings
- Cardiovascular Diseases, Asthma, Pulmonary Disease, Chronic Obstructive, Heart Failure, Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Walking Exercise ProgrammeOther
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 guidanceBehavioural
Real-time air quality information and guidance provided by the online platform.
| Study group | Role | What they receive |
|---|---|---|
| Air Quality Information Provided | Experimental | Participants receive the 12-week progressive walking programme through the P-STEP platform together with real-time PM2.5, PM10 and NO2 information and adaptive pollution-related guidance concerning exercise route, timing and/or intensity. Receives: Other: Progressive Walking Exercise Programme; Behavioral: Real-time air quality information and guidance |
| Air Quality Information Not Provided | Active comparator | Participants receive the same 12-week progressive walking programme through the P-STEP platform, with the same exercise guidance and tracking functions, but without air-quality information or pollution-related guidance. Receives: Other: Progressive Walking Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-week baseline and weekly throughout the 12 week intervention
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.
Measured: 1-week baseline and weekly throughout the 12 week intervention
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.
Measured: 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.
Measured: 1-week baseline and weekly throughout the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startOct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Ng, Ph.D, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500948
- Sponsor's protocol ID
- 1058
- Other IDs
- 348160
- Acronym
- EPIC-AIR
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared owing to the sensitive nature of the data collected, which includes continuous GPS-linked location tracking and personal physical activity monitoring. Sharing of granular location data at the individual level would risk re-identification of participants despite anonymisation. Aggregate summary data and analysis code will be made available upon reasonable request to the corresponding author following publication.
Publications
McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.
PubMed 18057337Sinharay R, Gong J, Barratt B, Ohman-Strickland P, Ernst S, Kelly FJ, Zhang JJ, Collins P, Cullinan P, Chung KF. Respiratory and cardiovascular responses to walking down a traffic-polluted road compared with walking in a traffic-free area in participants aged 60 years and older with chronic lung or heart disease and age-matched healthy controls: a randomised, crossover study. Lancet. 2018 Jan 27;391(10118):339-349. doi: 10.1016/S0140-6736(17)32643-0. Epub 2017 Dec 5.
PubMed 29221643Holgate ST. 'Every breath we take: the lifelong impact of air pollution' - a call for action. Clin Med (Lond). 2017 Feb;17(1):8-12. doi: 10.7861/clinmedicine.17-1-8.
PubMed 28148571
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation (EPIC-AIR)
- ClinicalTrials.gov ID
- NCT07500948
- Acronym / sponsor ID
- EPIC-AIR / 1058
- Conditions
- Cardiovascular Disease, Asthma, COPD, Interstitial Lung Disease Due to Systemic Disease, Heart Failure, Coronary Heart Disease (CHD)
- Keywords
- air pollution, cardiac rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
EPIC-AIR is a single-site, stratified, blinded, two-arm randomised controlled feasibility trial conducted at University Hospitals of Leicester NHS Trust. Up to 80 participants comprising cardiac rehabilitation patients, pulmonary rehabilitation patients and healthy volunteers will be recruited. Following a 1-week baseline monitoring period, participants will be stratified by participant group (cardiac rehabilitation, pulmonary rehabilitation or healthy volunteer) and randomised 1:1 within strata using a computer-generated allocation sequence via the Sealed Envelope secure web-based system.
All participants will receive a Fitbit Charge 6 and a 12-week progressive walking programme delivered through the P-STEP platform. Participants allocated to the intervention arm will additionally receive real-time local PM2.5, PM10 and NO2 information and adaptive guidance concerning the timing, location, route or intensity of outdoor activity. Participants in the control arm will use the same platform and receive the same exercise guidance but without air-quality information or pollution-related guidance.
The primary outcomes are three co-primary pollutant-specific measures: weekly time-weighted mean modelled ambient PM2.5, PM10 and NO2 concentrations during moderate-to-vigorous physical activity (MVPA). Time-stamped GPS locations recorded during activity will be linked to wearable-derived activity data and contemporaneous modelled air-quality concentrations. These outcomes represent modelled ambient concentrations encountered during recorded activity rather than directly measured personal inhaled dose.
Weekly pollution exposure during the 12-week intervention will be analysed using repeated-measures mixed-effects models accounting for participant clustering, baseline exposure, study week, randomisation stratum, sex and calendar week. The principal treatment contrast will be the adjusted average intervention-control difference across the 12-week post-allocation period. Multiplicity across the three co-primary pollutants will be controlled using the Holm procedure.
The registered secondary outcome is weekly physical activity derived from wrist-worn accelerometry. Additional clinical, physiological and patient-reported outcomes will be explored. Feasibility outcomes include recruitment, retention, adherence, completeness of outcome data and adverse events. A final follow-up assessment will take place 3 months after completion of the 12-week intervention. No participants had been recruited at the time the registry record was revised.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Quality Information Provided | Experimental | Other: Progressive Walking Exercise Programme, Behavioral: Real-time air quality information and guidanceParticipants receive the 12-week progressive walking programme through the P-STEP platform together with real-time PM2.5, PM10 and NO2 information and adaptive pollution-related guidance concerning exercise route, timing and/or intensity. |
| Air Quality Information Not Provided | Active comparator | Other: Progressive Walking Exercise ProgrammeParticipants receive the same 12-week progressive walking programme through the P-STEP platform, with the same exercise guidance and tracking functions, but without air-quality information or pollution-related guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Walking Exercise ProgrammeParticipants will receive a progressive, personalised walking exercise programme aimed to increase their weekly levels of physical activity over a 12 week study period. | Other | Air Quality Information Not Provided, Air Quality Information Provided |
| Real-time air quality information and guidanceReal-time air quality information and guidance provided by the online platform. | Behavioural | Air Quality Information Provided |
Primary outcome
Weekly time-weighted mean modelled ambient PM2.5 concentration during moderate-to-vigorous physical activity
Time frame: 1-week baseline and weekly throughout the 12 week intervention
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 frame: 1-week baseline and weekly throughout the 12 week intervention
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 frame: 1-week baseline and weekly throughout the 12 week intervention
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.
1 secondary outcome
Weekly physical activity (weekly minutes, measured by wrist-worn accelerometry)
Time frame: 1-week baseline and weekly throughout the 12-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 18057337McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.
- Background: PubMed 29221643Sinharay R, Gong J, Barratt B, Ohman-Strickland P, Ernst S, Kelly FJ, Zhang JJ, Collins P, Cullinan P, Chung KF. Respiratory and cardiovascular responses to walking down a traffic-polluted road compared with walking in a traffic-free area in participants aged 60 years and older with chronic lung or heart disease and age-matched healthy controls: a randomised, crossover study. Lancet. 2018 Jan 27;391(10118):339-349. doi: 10.1016/S0140-6736(17)32643-0. Epub 2017 Dec 5.
- Background: PubMed 28148571Holgate ST. 'Every breath we take: the lifelong impact of air pollution' - a call for action. Clin Med (Lond). 2017 Feb;17(1):8-12. doi: 10.7861/clinmedicine.17-1-8.
- World Health Organization. Ambient (outdoor) air pollution. 2022Link provided by the sponsor.
- Committee on the Medical Effects of Air Pollutants (COMEAP). Statement: overview of advice provided to the Air Quality Information System (AQIS) review steering group. London: COMEAP; 2024.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared owing to the sensitive nature of the data collected, which includes continuous GPS-linked location tracking and personal physical activity monitoring. Sharing of granular location data at the individual level would risk re-identification of participants despite anonymisation. Aggregate summary data and analysis code will be made available upon reasonable request to the corresponding author following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andre Ng, Ph.D, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Walking Exercise Programme and Real-time air quality information and guidance in people with Cardiovascular Disease and Asthma, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James A Donaldson, Ph.D (+447990571690, jad72@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly time-weighted mean modelled ambient PM2.5 concentration during moderate-to-vigorous physical activity (time frame: 1-week baseline and weekly throughout the 12 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07500948, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.