Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT04642066 |
Other study ID # |
LF UPJS |
Secondary ID |
|
Status |
Suspended |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 25, 2018 |
Est. completion date |
June 30, 2026 |
Study information
Verified date |
November 2023 |
Source |
Pavol Jozef Safarik University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.