Cardiovascular SystemNCT04153539
Acute Health Effects of Traffic-Related Air Pollution Exposure
A study testing Walking along a busy road and Walking in a traffic-free park in people with Cardiovascular System and Respiratory System, run by Fudan University at 1 site in China.
Trial summary
This study aims to assess the effects of acute exposure to traffic-related air pollution and the underlying mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular System, Respiratory System
- What is being tested?
- Walking along a busy road and Walking in a traffic-free park
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2019to 31 Dec 2026
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in Shanghai during the study period;
- Body mass index > 18.5 and ≤ 28;
- Non-smoking, no history of alcohol or drug abuse;
- Completing the walking task we required.
Who cannot join
- Current or ever smokers;
- Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
- Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
- Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
- Subjects wih chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
- Subjects with a history of major surgery;
- Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
- Medication use or dietary supplements intake in recent two months;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Acute Health Effects of Traffic-Related Air Pollution Exposure Among Healthy Young Adults: A Randomized, Crossover Trial
This study aims to assess the effects of acute exposure to traffic-related air pollution and the underlying mechanisms.
Read the detailed description
The investigators will conduct a randomized, crossover trial among 72 healthy young adults in Shanghai, China. The eligible participants will be randomly divided into 2 groups (36 volunteers per group). During the first stage, participants will be requested to take one walking task (from 13:00 to 17:30). The exposed group will walk along a busy road and be exposed to traffic-related air pollution, while the control group will walk in a traffic-free park. During the first 3 hours, all participants will rest for 30 minutes after each 15-minute walking. From 16:00, participants will stop walking and rest for 1.5 hours. Then both groups will enter a 2-week washout period. In the second stage, there will also be one walking task (from 13:00 to 17:30). The two groups will exchange their walking sites and repeat the previous trial. Physical examinations will be performed both before and after each walking task. Besides, we will ask volunteers to stay in school during the two days before walking. Health examinations include symptoms questionnaires, blood pressure tests, Holter monitoring, and spirometry. We plan to collect blood, urine, oropharyngeal swabs, and exhaled breath condensate before exposure, about one hour after exposure, and next morning.
- Conditions
- Cardiovascular System, Respiratory System
- Being tested
- Walking along a busy road, Walking in a traffic-free park
- Keywords
- Traffic-related pollution, Randomized controlled trial, Acute health effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking along a busy roadBehavioural
The intervention group will walk along a busy road and be exposed to traffic-related air pollution for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods.
Walking in a traffic-free parkBehavioural
The control group will walk in a traffic-free park for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods.
| Study group | Role | What they receive |
|---|---|---|
| Walking along a busy road | Experimental | Participants in this group will be asked to walk along a busy road for 4.5 hours. Receives: Behavioral: Walking along a busy road |
| Walking in a traffic-free park | Active comparator | Participants in this group will be asked to walk in a traffic-free park for 4.5 hours. Receives: Behavioral: Walking in a traffic-free park |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FEV1
We plan to measure changes in forced expiratory volume in 1 second.
Measured: FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.
Blood Pressure
We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Measured: Blood pressure will be measured for 24 hours from 8:00 am on the morning of intervention to 8:00 am on the next morning.
Heart Rate Variability Parameters
We plan to measure heart rate variability (HRV) parameters.
Measured: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 8:00 am on the morning of intervention to 8:00 am on the next morning.
Secondary outcomes (3)
Changes of FVC
Changes of forced vital capacity
Measured: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Changes of FEV1/FVC
Changes of the ratio of forced expired volume in 1 second (FEV1) to forced vital capacity (FVC)
Measured: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Changes of MMEF
Changes of maximal mid-expiratory flow
Measured: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start9 Oct 2019
- Primary completion8 Dec 2019
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SystemStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Kan, Fudan University
- Investigators
- Haidong Kan, PhD, Study director, Department of Environmental Health, School of Public Health, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153539
- Sponsor's protocol ID
- FDUEH-6
- Status last verified
- Feb 2026
- First submitted
- 3 Nov 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Health Effects of Traffic-Related Air Pollution Exposure Among Healthy Young Adults: A Randomized, Crossover Trial
- ClinicalTrials.gov ID
- NCT04153539
- Acronym / sponsor ID
- FDUEH-6
- Conditions
- Cardiovascular System, Respiratory System
- Keywords
- Traffic-related pollution, Randomized controlled trial, Acute health effects
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Nov 2019 (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.
This study aims to assess the effects of acute exposure to traffic-related air pollution and the underlying mechanisms.
Detailed description
The investigators will conduct a randomized, crossover trial among 72 healthy young adults in Shanghai, China. The eligible participants will be randomly divided into 2 groups (36 volunteers per group). During the first stage, participants will be requested to take one walking task (from 13:00 to 17:30). The exposed group will walk along a busy road and be exposed to traffic-related air pollution, while the control group will walk in a traffic-free park. During the first 3 hours, all participants will rest for 30 minutes after each 15-minute walking. From 16:00, participants will stop walking and rest for 1.5 hours. Then both groups will enter a 2-week washout period. In the second stage, there will also be one walking task (from 13:00 to 17:30). The two groups will exchange their walking sites and repeat the previous trial. Physical examinations will be performed both before and after each walking task. Besides, we will ask volunteers to stay in school during the two days before walking. Health examinations include symptoms questionnaires, blood pressure tests, Holter monitoring, and spirometry. We plan to collect blood, urine, oropharyngeal swabs, and exhaled breath condensate before exposure, about one hour after exposure, and next morning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking along a busy road | Experimental | Behavioral: Walking along a busy roadParticipants in this group will be asked to walk along a busy road for 4.5 hours. |
| Walking in a traffic-free park | Active comparator | Behavioral: Walking in a traffic-free parkParticipants in this group will be asked to walk in a traffic-free park for 4.5 hours. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Living in Shanghai during the study period;
- Body mass index > 18.5 and ≤ 28;
- Non-smoking, no history of alcohol or drug abuse;
- Completing the walking task we required.
Key exclusion criteria (8 listed)
- Current or ever smokers;
- Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
- Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
- Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
- Subjects wih chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
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 |
|---|---|---|
| Walking along a busy roadThe intervention group will walk along a busy road and be exposed to traffic-related air pollution for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods. | Behavioural | Walking along a busy road |
| Walking in a traffic-free parkThe control group will walk in a traffic-free park for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods. | Behavioural | Walking in a traffic-free park |
Primary outcome
Changes in FEV1
Time frame: FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.
We plan to measure changes in forced expiratory volume in 1 second.
Blood Pressure
Time frame: Blood pressure will be measured for 24 hours from 8:00 am on the morning of intervention to 8:00 am on the next morning.
We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Heart Rate Variability Parameters
Time frame: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 8:00 am on the morning of intervention to 8:00 am on the next morning.
We plan to measure heart rate variability (HRV) parameters.
3 secondary outcomes
Changes of FVC
Time frame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Changes of FEV1/FVC
Time frame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Changes of MMEF
Time frame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Haidong Kan, PhD study director
Department of Environmental Health, School of Public Health, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking along a busy road and Walking in a traffic-free park in people with Cardiovascular System and Respiratory System, run by Fudan University at 1 site in China.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FEV1 (time frame: FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.). 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?
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 2 Sep 2026.