Acute Effects of Cold Exposure on Cardiovascular System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low temperature (15°C) group, Moderate temperature (22°C) group.
- Who it may be relevant to
- Registry conditions: Cardiovascular System. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
Overview
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.
Detailed description
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.
Interventions
- Other Low temperature (15°C) group
The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods. - Other Moderate temperature (22°C) group
The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
Primary outcome measures
- Blood Pressure [Time frame: Blood pressure will be examined before exposure and immediately after the exposure session]
- SDNN (standard deviation of NN intervals) [Time frame: 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.]
- SDANN (standard deviation of the averages of RR intervals) [Time frame: 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.]
- rMSSD (root mean square of successive differences) [Time frame: 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.]
- pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms) [Time frame: 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.]
- Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio [Time frame: 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.]
Secondary outcome measures (2)
- Changes of scores of symptoms questionnaires [Time frame: The questionnaires will be conducted before exposure and immediately after the exposure]
- Changes of skin temperature [Time frame: Skin temperature will be examined during the 2-hour exposure session]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Environmental Health, School of Public Health, Fudan University — Shanghai
Identifiers
NCT: NCT06652425 · IRB#2024-10-1167