NCT07500948

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
May 2026Mar 2027

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

air pollutioncardiac rehabilitationexercise

Outcome Measures

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.

    Baseline to 12 weeks

Secondary Outcomes (1)

  • Weekly physical activity (weekly minutes, measured by wrist-worn accelerometry)

    Baseline to 12 weeks

Study Arms (2)

Air Quality Information Provided

EXPERIMENTAL

In this arm, participants will receive the exercise training programme alongside detailed local air quality information.

Other: Progressive Walking Exercise Programme

Air Quality Information Not Provided

ACTIVE COMPARATOR

In this arm, participants will receive the exercise training programme only.

Other: Progressive Walking Exercise Programme

Interventions

Participants will receive a progressive, personalised walking exercise programme aimed to increase their weekly levels of physical activity over a 12 week study period.

Air Quality Information Not ProvidedAir Quality Information Provided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 18057337BACKGROUND
  • Sinharay 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.

    PMID: 29221643BACKGROUND
  • Holgate 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.

    PMID: 28148571BACKGROUND

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesAsthmaPulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Andre Ng, Ph.D, MD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James A Donaldson, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.