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临床试验/NCT04642066
NCT04642066暂停不适用

Effect of Repeatedly Applied Cold Water Immersion on Subclinical Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters of Volunteers

Pavol Jozef Safarik University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
60
试验地点
2
主要终点
Fatty acid profile

研究概览

简要总结

The impact of the environment on human health is considerable. An important factor is the effect of temperature on the human body, where either the effects of short-term exposure to extreme temperatures (cryotherapy, sauna, etc.) or the long-term environmental impact are monitored.

The study was focused on research of the long-term effect of repeated CWI on atherogenesis, lipid parameters and fat distribution.

详细描述

This study was designed as a cohort observational studyfollowing the group of volunteers practicing CWI. Totally forty volunteers agreed to participate in the study by signing the informed consent, approved by the local ethics committee of UPJŠ Košice. Volunteers were examined in Cardiology and General Medicine outpatient clinics of Faculty of medicine, UPJŠ Košice (1st Department of Internal Medicine; outpatient clinics of Medicomp Košice Ltd.). They underwent the anamnesis and examination with a focus in the first step on matching the inclusion criteria: SCORE for the assessment of the cardiovascular risk as low (≤1%), patients without the suspected diagnosis of the familialhypercholesterolemia, respectively with TC level above 8 mmol/L, respectively TG concentrations above 2.3 mmol/L, male gender, age between 21 and 60, signed informed consent to participate in the study.

Patients with one or more exclusion criteria were not included: volunteers with lipid-lowering therapy or those that received hypolipidemics in the period shorter than 3 months before the study, values of blood lipids outside the inclusion criteria, glucose intolerance and DM,presence of advanced cardiovascular (plague or coronary artery disease, TIA, stroke, etc.) or chronic inflammatory diseases, infection or diseases possible affecting measured parameters and significant lifestyle changes in the last period of 6 months before the CWI.

After the initial examination, 35 volunteers fulfilled the criteria. Volunteers of the study underwent controlled, repeated CWI (5 months 15/11/18 - 15/03/19)based on a following pre-prepared protocol in the cooperation of our physicians and the sport club: Full body CWI in open standing, except the head (same location, timing), frequency three times a weekin the duration of 7-10 minutes. Swimming was permitted. Volunteers must not use neoprene aids (gloves, shoes), caps were allowed. Volunteers should be in the final phase submerged in water, above which there should only be the head and neck. The upper limbs were below the water surface. Non-neoprene footwear was permitted. Volunteers entered the water continuously without stopping. The time of stay in water was calculated from the first contact of the foot with water. On average, the whole body needed to be immersed in water within 30 seconds. The entire study was performed in the nearby lake, where all participants in the active arm were exposed to the same weather and water conditions, which were monitored. Volunteers who did not follow the protocol in more than 15% of the episodes, respectively, with weight, fat or muscle mass changes over 5%, with significant dietary changes were excluded from the study. Equivalent sham control group (N=30) was included fulfilling the inclusion criteria, without the CWI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • without cardiovascular and metabolic disease cold water immersion

排除标准

  • cancer inflammatory diseases cardovascular diseases tuberculosis renal and hepatic insufficiency pregnancy cardiovascular diseases obesity metabolic syndrome lymphoproliferative disorders liver transplantation in the past suspected. chronic infection in risk locations

结局指标

主要结局

Fatty acid profile

时间窗: 6 months

mol/l

AU

时间窗: 6 months

PWV

时间窗: 6 months

m/s

Beta

时间窗: 6 months

SF

时间窗: 6 months

mm

VF

时间窗: 6 months

mm

Change in total cholesterol from baseline

时间窗: 6 months

percentual change in total cholesterol (mmoL/L)

Body mass index

时间窗: 6 months

BMI kg/m2

Concentrations of PCSK9, hsCRP and other inflammation markers

时间窗: 6 months

mmol/l

cIMT

时间窗: 6 months

mm

次要结局

未报告次要终点

研究者

发起方
Pavol Jozef Safarik University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Janičko

Assistant Professor

Pavol Jozef Safarik University

研究点 (2)

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