Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
This is a randomized controlled human exposure crossover study. Investigators aim to assess the acute effects of low temperature exposure on cardiovascular system and the underlying mechanisms.
详细描述
The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15°C) and once to the moderate temperature (22°C) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include blood pressure tests and Holter monitoring. Investigators plan to collect blood and urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in Shanghai during the study period;
- •Body mass index > 18.5 and ≤ 28;
- •Right-handed;
- •Receiving or having received higher education;
- •With the ability to read and understand Chinese smoothly.
排除标准
- •Smoking and alcohol abuse;
- •Current drug and dietary supplements intake;
- •Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
- •Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
- •Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
- •Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
- •Subjects who have a history of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases;
- •Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
- •Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
- •Subjects with color vision disabilities.
研究组 & 干预措施
Low temperature (15°C) group
Subjects in exposure group will be exposed to low temperature (15°C) for about 2 hours in a chamber.
干预措施: Low temperature (15°C) group (Other)
Moderate temperature (22°C) group
Subjects in exposure group will be exposed to moderate temperature (22°C) for about 2 hours in a chamber.
干预措施: Moderate temperature (22°C) group (Other)
结局指标
主要结局
Blood Pressure
时间窗: Blood pressure will be examined before exposure and immediately after the exposure session
The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.
SDNN (standard deviation of NN intervals)
时间窗: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.
Investigators plan to measure heart rate variability (HRV) parameter SDNN
SDANN (standard deviation of the averages of RR intervals)
时间窗: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.
Investigators plan to measure heart rate variability parameter SDANN
rMSSD (root mean square of successive differences)
时间窗: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.
Investigators plan to measure heart rate variability (HRV) parameter rMSSD
pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)
时间窗: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.
Investigators plan to measure heart rate variability (HRV) parameter pNN50
Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio
时间窗: Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.
Investigators plan to measure frequency domain parameters of heart rate variability (HRV)
次要结局
- Changes of scores of symptoms questionnaires(The questionnaires will be conducted before exposure and immediately after the exposure)
- Changes of skin temperature(Skin temperature will be examined during the 2-hour exposure session)