Actively Recruiting
Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
Led by Fudan University · Updated on 2025-02-27
40
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled crossover study to explore how brief exposure to low temperature affects the cardiovascular system and its underlying mechanisms. This study involves about 40 healthy young adults living in Shanghai, China, aiming to understand acute cardiovascular responses to cold exposure compared to moderate temperature conditions. Participants will experience two separate exposure sessions in a controlled chamber: one at low temperature (15 0C) and one at moderate temperature (22 0C), each lasting about 2 hours. During these sessions, participants will rest quietly. The study design allows comparison of cardiovascular effects between the two temperature settings. Throughout the study, participants will undergo health examinations before, during, and after exposure sessions. These include blood pressure measurements and continuous heart monitoring via Holter monitors worn for 24 hours starting at 1:00 P.M. on the day of exposure. Blood and urine samples will also be collected. Questionnaires about symptoms and skin temperature monitoring during exposure will provide additional data. The study evaluates detailed heart rate variability measures and blood pressure changes to understand cold exposure impacts.
CONDITIONS
Brief Title
Acute Effects of Cold Exposure on Cardiovascular System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living in Shanghai during the study period
- Body mass index > 18.5 and 28
- Right-handed
- Receiving or having received higher education
- Able to read and understand Chinese smoothly
You will not qualify if you...
- Smoking and alcohol abuse
- Current drug and dietary supplements intake
- Allergic diseases such as allergic rhinitis, allergic asthma, and atopy
- Cardiovascular diseases such as congenital heart disease, pulmonary heart disease, and hypertension
- Respiratory diseases such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease
- Chronic diseases such as diabetes, chronic hepatitis, and kidney disease
- History of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases
- Neurologic disorders such as stroke, traumatic brain injury, epilepsy, and schizophrenia
- Abnormal spirometry results (FEV1 and FVC 75% of predicted and FEV1/FVC 0.65)
- Color vision disabilities
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each exposure lasts about 2 hours; total duration depends on crossover schedule
Participants are exposed twice in random order to low temperature (15°C) and moderate temperature (22°C) in a chamber for about 2 hours each time, resting during the exposure sessions. Health examinations including blood pressure tests and Holter monitoring are conducted before, during, and after each exposure. Blood and urine samples are also collected.
2 exposure visits (in-person) with 24-hour Holter monitoring each
Trial Site Locations
Total: 1 location
1
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
R
Renjie Chen, PhD
H
Haidong Kan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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