COVID-19 in Polish Ice Swimmers. (ICE)

April 6, 2021 updated by: Wroclaw Medical University

Influence of Ice Swimming on Hardening Against SARS-CoV-2 and Influence of AB0 Rh Blood Type on Viral Resistance in Polish Ice Swimmers.

Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. In the face of the current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic causing Coronavirus Disease 2019 (COVID-19), researchers decided to use a survey to check the incidence of COVID-19 among Polish ice swimmers, as well as recent ailments. Then, the researchers will compare the obtained results with epidemiological data for Poland.Researchers will also investigate the relationship between susceptibility to SARS-CoV-2 infection and the blood group and Rh factor among ice swimmers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research tool is an original questionnaire compiled by a team of experts conducting the study. The survey includes questions about sociodemographic data, such as age and gender and blood type in AB0 system with Rh factor, and questions about the frequency of ice swimming, the duration of a single session, and since when respondents have been ice swimming. There was also a question about the respondents' compliance with the restrictions and recommendations related to the pandemic and contacts with people with confirmed SARS-CoV-2 infection. In the survey, researchers ask about the infectious symptoms experienced during the pandemic and about being diagnosed with COVID-19 or its exclusion. People who have been ill are asked about the place of treatment.

The questionnaires are collected in traditional form, on the Internet and as scans of documents. Each survey was completely anonymous. The obtained statistical data will be compared with official data on new COVID-19 cases and recoveries at the same time. Official data are published by the Ministry of Health and earlier also by Sanitary and Epidemiological Stations. The main aim of the study was to determine whether ice swimming also increases resistance to SARS-CoV-2 and COVID-19.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Dolny Slask
      • Wrocław, Dolny Slask, Poland, 51-618
        • Department of Public Health at Wroclaw Medical University
    • Lubuskie
      • Gorzów Wielkopolski, Lubuskie, Poland, 66-400
        • Department of Radiotherapy of Multidisciplinary Provincial Hospital
      • Zielona Góra, Lubuskie, Poland, 65-031
        • Treasury Medical Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surveys are distributed en masse among ice swimmers from Poland. Comparative data for the control group is derived from officially published national and regional pandemic data.

Description

Inclusion Criteria:

  • ice swimmers

Exclusion Criteria:

  • not active ice swimmers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ice Swimmers Group.
No intervention. Data obtained from Polish ice swimmers reported by them retrospectively in the questionnaire.
Other: Ice Swimming
The intervention is not made in the course of a research study. Ice swimming has been introduced earlier by a given group. The group was made up of people who already swim in ice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of the incidence of COVID-19 among ice swimmers compared to the general population.
Time Frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
47 days.
Assessment of the frequency of asymptomatic SARS-CoV-2 infection among ice swimmers compared to the general population.
Time Frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
47 days.
Assessment of the frequency of occurrence of particular symptoms of SARS-CoV-2 infection among ice swimmers compared to the general population.
Time Frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
47 days.
Assessment of the frequency of COVID-19 treatment in an outpatient, inpatient and intensive care unit among ice swimmers compared to the general population.
Time Frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
47 days.
Assessment of the impact of parameters and ice swimming strategies on the likelihood of developing COVID-19, the occurrence of individual symptoms of the disease and the severity of its course.
Time Frame: 47 days.
Inference from data obtained from surveys collected among ice swimmers.
47 days.
Assessment of the influence of blood group on susceptibility to SARS-CoV-2 infection among ice swimmers.
Time Frame: 47 days.
Inference from data obtained from surveys collected among ice swimmers.
47 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of the immunity of the ice swimmer's immune system compared to the general population.
Time Frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
47 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wroclaw Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sylwia Sulimiera Michalak, MD, PhD, Department of Pharmacology and Toxicology, Medical University of Zielona Gora
  • Study Director: Edyta Wolny-Rokicka, MD, PhD, Department and Center of Radiotherapy, Multidisciplinary Provincial Hospital in Gorzow Wielkopolski
  • Study Chair: Andrzej Tukiendorf, Prof., Department of Public Health, Wroclaw Medical University
  • Principal Investigator: Lukasz K Wysoczanski, MD, Department of Family Medicine, Wroclaw Medical University
  • Principal Investigator: Paulina N Wysoczanska, MD, Department of Family Medicine, Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KB-03/139/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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