Acute Health Effects of Traffic-Related Air Pollution Exposure

Not Applicable

• Conditions: Cardiovascular System; Respiratory System
• Interventions: Behavioral: Walking along a busy road; Behavioral: Walking in a traffic-free park

• Registration Number: NCT04153539
• Lead Sponsor: Fudan University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-09
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Primary Completion: 2019-12-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Walking along a busy road	Walking along a busy road	Participants in this group will be asked to walk along a busy road for 4.5 hours.
Walking in a traffic-free park	Walking in a traffic-free park	Participants in this group will be asked to walk in a traffic-free park for 4.5 hours.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	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	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.
Changes in FEV1	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.

Secondary Outcome Measures

Name	Time	Method
Changes of FEV1/FVC	7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)	Changes of the ratio of forced expired volume in 1 second (FEV1) to forced vital capacity (FVC)
Changes of FVC	7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)	Changes of forced vital capacity
Changes of MMEF	7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)	Changes of maximal mid-expiratory flow

Trial Locations

Locations (1)

Department of Environmental Health, School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China