NCT04817280

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

March 24, 2021

Last Update Submit

April 6, 2021

Conditions

Keywords

Ice SwimImmune SystemImmunityTemporarily cooling down

Outcome Measures

Primary Outcomes (6)

  • Assessment of the incidence of COVID-19 among ice swimmers compared to the general population.

    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.

    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.

    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.

    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.

    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.

    Inference from data obtained from surveys collected among ice swimmers.

    47 days.

Secondary Outcomes (1)

  • Assessment of the immunity of the ice swimmer's immune system compared to the general population.

    47 days.

Study Arms (1)

Ice Swimmers Group.

No intervention. Data obtained from Polish ice swimmers reported by them retrospectively in the questionnaire.

Other: Ice Swimming

Interventions

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.

Ice Swimmers Group.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ice swimmers

You may not qualify if:

  • not active ice swimmers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Public Health at Wroclaw Medical University

Wroclaw, Dolny Slask, 51-618, Poland

Location

Department of Radiotherapy of Multidisciplinary Provincial Hospital

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

Location

Treasury Medical Company

Zielona Góra, Lubusz Voivodeship, 65-031, Poland

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromeDisease ResistanceHypothermia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and Symptoms

Study Officials

  • 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 DIRECTOR
  • Andrzej Tukiendorf, Prof.

    Department of Public Health, Wroclaw Medical University

    STUDY CHAIR
  • Lukasz K Wysoczanski, MD

    Department of Family Medicine, Wroclaw Medical University

    PRINCIPAL INVESTIGATOR
  • Paulina N Wysoczanska, MD

    Department of Family Medicine, Wroclaw Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

December 1, 2020

Primary Completion

January 17, 2021

Study Completion

March 1, 2021

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations