Nctid:
NCT06223087
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2021-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-15", "studyFirstSubmitDate"=>"2023-12-30", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"blood sampling: platelets and leukocytes", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Measurements of:\n\nPlatelets \\[thousands/μl\\], Leukocytes \\[thousands/μl\\], Neutrophils \\[thousands/μl\\], Eosinophils \\[thousands/μl\\], Basophils \\[thousands/μl\\], Lymphocytes \\[thousands/μl\\], Monocytes \\[thousands/μl\\]."}, {"measure"=>"blood sampling: erythrocytes", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Measurement of:\n\nErythrocytes \\[mln/μl\\],"}, {"measure"=>"blood sampling: haemoglobin", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of:\n\nHaemoglobin \\[g/dl\\], mean corpuscular haemoglobin concentration (MCHC) \\[g/dl\\],"}, {"measure"=>"blood sampling: haematocrit", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of:\n\nhaematocrit \\[%\\], red blood cell distribution width coefficient of variation (RDW-CV) \\[%\\],"}, {"measure"=>"blood sampling: haemoglobin mass", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of:\n\nmean corpuscular haemoglobin (MCH) \\[pg\\],"}, {"measure"=>"blood sampling: Erythrocytes", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of mean corpuscular volume (MCV) \\[fl\\], red blood cell distribution width standard deviation (RDW-SD) \\[fl\\],"}, {"measure"=>"blood sampling: rheology part 1", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of red cell elongation index (EI) \\[arbitrary unit: AU\\], erythrocyte aggregation amplitude (AMP) \\[AU\\],"}, {"measure"=>"blood sampling: rheology part 2", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of:\n\naggregation index (AI) \\[%\\],"}, {"measure"=>"blood sampling:rheology part 3", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of:\n\nhalf-time of total aggregation (t1/2) \\[s\\]."}, {"measure"=>"blood sampling: oxidative stress", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Measurement of catalase (CAT) \\[nmol/min/ml\\], and glutathione peroxidase (GPx) \\[nmol/min/ml\\]."}, {"measure"=>"blood sampling: oxidative stress - superoxide dismutase", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Measurement of superoxide dismutase (SOD) \\[U/ml\\],"}, {"measure"=>"blood biochemistry: Urea", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Measurement of:\n\nUrea \\[mmol/l\\]."}, {"measure"=>"blood sampling: Testosterone", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of Testosterone concentration \\[ng/dl\\],"}, {"measure"=>"blood sampling: Cortisol", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of Cortisol concentration \\[µg/dl\\],"}, {"measure"=>"blood biochemistry: Creatine", "timeFrame"=>"twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming", "description"=>"Determination of Creatinine concentration \\[µmol/l\\],"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["blood", "rheology", "cold", "blood morphology", "biochemistry", "exercise"], "conditions"=>["Cold Exposure"]}, "descriptionModule"=>{"briefSummary"=>"Exposure of the human body to cold water triggers numerous beneficial physiological changes. The study aimed to assess the impact of regular winter swimming on blood morphological, rheological, and biochemical indicators and activity of antioxidant enzymes in males. The study includes winter swimmers and a control group. Blood samples were taken twice - before the start (November) of the winter swimming season and after its end (March). The average duration of ice water baths was 3-5 minutes, with a minimum frequency of once a week. The water temperature during the swimming did not exceed 10°C, approaching 0°C during the winter period."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"25 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Experienced in winter swimming, regularly swimming in cold water (open water) at least once a week in the period November - March", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Good health, practitioners of winter swimming\n* control group: never did winter swimming and had a sedentary lifestyle.\n\nExclusion Criteria:\n\n* medical contraindications to winter bathing"}, "identificationModule"=>{"nctId"=>"NCT06223087", "briefTitle"=>"Effects of Winter Swimming on Blood Indicators and Oxidative Stress in Males", "organization"=>{"class"=>"OTHER", "fullName"=>"University School of Physical Education, Krakow, Poland"}, "officialTitle"=>"Effects of Winter Swimming on Blood Morphological, Rheological, and Biochemical Indicators and Oxidative Stress in Males", "orgStudyIdInfo"=>{"id"=>"296/BS/INP/2021"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"control", "description"=>"group not practicing winter swimming"}, {"label"=>"winter swimmers", "description"=>"group practicing winter swimming", "interventionNames"=>["Other: winter swimming"]}], "interventions"=>[{"name"=>"winter swimming", "type"=>"OTHER", "description"=>"Intervention involves bathing/swimming in cold water during the winter months in open waters", "armGroupLabels"=>["winter swimmers"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"31571", "city"=>"Kraków", "country"=>"Poland", "facility"=>"University of Physical Education", "geoPoint"=>{"lat"=>50.06143, "lon"=>19.93658}}], "overallOfficials"=>[{"name"=>"Aneta Teleglow", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Physical Education, Kraków, Poland"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University School of Physical Education, Krakow, Poland", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Head of Blood Physiology Laboratory", "investigatorFullName"=>"Aneta Teleglow", "investigatorAffiliation"=>"University School of Physical Education, Krakow, Poland"}}}}
