Cardiovascular Risk FactorNCT04642066
Cold Water Immersion and Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters
A study testing Cold water immersion and No cold water immersion in people with Cardiovascular Risk Factor and Metabolic Complication, run by Pavol Jozef Safarik University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Metabolic Complication, Endocrine; Complications
- What is being tested?
- Cold water immersion and No cold water immersion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSlovakia
- Study dates
- 25 Oct 2018to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- without cardiovascular and metabolic disease cold water immersion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
1st Department of Internal medicine, L. Pasteur University Hospital in Košice
Košice, 04011
About this study
Official title: Effect of Repeatedly Applied Cold Water Immersion on Subclinical Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters of Volunteers
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.
Read the detailed 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.
- Conditions
- Cardiovascular Risk Factor, Metabolic Complication, Endocrine; Complications, Immune System Diseases
- Being tested
- Cold water immersion, No cold water immersion
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water immersionOther
Full body CWI in open standing, except the head (same location, timing), frequency three times a week in 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.
No cold water immersionOther
People without cold water immersion
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | Healthy volunteers were followed during the 5-month CWI exposition under standard conditions (three times per week 7-10 min). Neoprene equipment was not allowed; volunteers with followed weight or muscle mass changes over 5% were excluded Receives: Other: Cold water immersion |
| Sham control | Sham comparator | Control without CWI exposition Receives: Other: No cold water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
BMI kg/m2
Measured: 6 months
Change in total cholesterol from baseline
percentual change in total cholesterol (mmoL/L)
Measured: 6 months
Concentrations of PCSK9, hsCRP and other inflammation markers
mmol/l
Measured: 6 months
cIMT
mm
Measured: 6 months
PWV
m/s
Measured: 6 months
Beta
Measured: 6 months
AU
Measured: 6 months
SF
mm
Measured: 6 months
VF
mm
Measured: 6 months
Fatty acid profile
mol/l
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start25 Oct 2018
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: funding not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Janičko, Pavol Jozef Safarik University
- Investigators
- Stefan Tóth, MUDr., PhD, Principal investigator, Pavol Joef Safárik University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642066
- Sponsor's protocol ID
- LF UPJS
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeatedly Applied Cold Water Immersion on Subclinical Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters of Volunteers
- ClinicalTrials.gov ID
- NCT04642066
- Acronym / sponsor ID
- LF UPJS
- Conditions
- Cardiovascular Risk Factor, Metabolic Complication, Endocrine; Complications, Immune System Diseases
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: funding not obtained
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Other: Cold water immersionHealthy volunteers were followed during the 5-month CWI exposition under standard conditions (three times per week 7-10 min). Neoprene equipment was not allowed; volunteers with followed weight or muscle mass changes over 5% were excluded |
| Sham control | Sham comparator | Other: No cold water immersionControl without CWI exposition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- without cardiovascular and metabolic disease cold water immersion
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold water immersionFull body CWI in open standing, except the head (same location, timing), frequency three times a week in 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. | Other | Active Group |
| No cold water immersionPeople without cold water immersion | Other | Sham control |
Primary outcome
Body mass index
Time frame: 6 months
BMI kg/m2
Change in total cholesterol from baseline
Time frame: 6 months
percentual change in total cholesterol (mmoL/L)
Concentrations of PCSK9, hsCRP and other inflammation markers
Time frame: 6 months
mmol/l
cIMT
Time frame: 6 months
mm
PWV
Time frame: 6 months
m/s
Beta
Time frame: 6 months
AU
Time frame: 6 months
SF
Time frame: 6 months
mm
VF
Time frame: 6 months
mm
Fatty acid profile
Time frame: 6 months
mol/l
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Tóth, MUDr., PhD principal investigator
Pavol Joef Safárik University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water immersion and No cold water immersion in people with Cardiovascular Risk Factor and Metabolic Complication, run by Pavol Jozef Safarik University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.