- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07664072
Single Effort in Air Temperature of Minus 10°C
Single Effort in Air Temperature of Minus 10°C Changes the Erythrocyte Aggregation Indicators in Young Healthy Men
Exercise in the cold is an attractive option for many athletes. Erythrocyte aggregation, as one of the main rheological parameters, constitutes an important indicator of microcirculation and oxygen transport capacity in the human body; therefore, its changes in response to exercise and cold are of clinical and physiological relevance. The purpose of the study was to determine the effects of a single physical effort at low temperature (-10°C) in a thermal climate chamber on the red blood cell system, erythrocyte aggregation, lactate, cortisol, and testosterone in healthy males.
Methods: The study was experimental in nature and assumed a comparison of the body response to exercise performed at reduced (-10°C) and neutral (18°C) temperatures. It involved 30 healthy males, students of physiotherapy at the University of Physical Culture in Krakow, Poland. The enrolled individuals were divided into 2 groups: group 1 (n = 15) ran in a thermal climate chamber at an air temperature of -10°C, group 2 (n = 15) ran in the fresh air at a neutral air temperature of 18°C.
Přehled studie
Detailní popis
2.1 Study group characteristics The study involved 30 healthy males, students of the University of Physical Culture in Krakow, Poland, faculty of physiotherapy. Their mean body height was 178.9 ± 6.5 cm, mean body mass equaled 76.8 ± 11.3 kg. After the subjects were assigned to each group, the average body height in the experimental group (177.9 ± 5.9 cm) and in the control/neutral group (179.9 ± 7.2 cm) was calculated. The average body mass in the experimental group (73.1 ± 6.6 kg) was lower than that in the control group (81.2 ± 14.1 kg).
Simple randomization with a 1:1 allocation ratio served to randomly assign the participants to the experimental or control group. This was done before the first blood sampling, with the randomization sequence generated prior to the study. No stratification factors were used. The participants in the experimental group performed physical exertion under the conditions of low temperature (-10°C). The workout was undertaken in a thermal climate chamber in the Laboratory for Climate Technology Research and Heavy Duty Machines, Cracow University of Technology in Krakow. The thermal climate chamber meets the requirements of the PN-EN ISO/IEC 17025:2005 standard and possesses an accreditation certificate No. AB 1678, issued by the Polish Centre for Accreditation. The Laboratory for Climate Technology Research and Heavy Duty Machines is a research center accredited in the field of defense and security by the Minister of National Defense (accreditation No.: 55/MON/2018). The control group, in turn, performed the same physical effort but in the open air, in thermoneutral conditions (the air temperature was 18.1°C on the day of the study).
The experiment comprised 3 stages: (1) Before the exercise, blood samples were taken from the participants. This was performed in the morning hours on 11 May 2024 at the Blood Physiology Laboratory of the Central Research and Development Laboratory, University of Physical Culture in Krakow. (2) Both groups undertook an exertion test. (3) Blood samples were collected from all participants again after the exercise.
The study followed the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of the Regional Medical Chamber in Krakow, Poland 2.2 Research method A two-factor experimental design with repeated measures was employed in the study. Ambient temperature (low vs. thermoneutral) constituted the between-subject factor; time of measurement (pre- and post-exercise) was the within-subject factor. The study followed the design of an exploratory investigation. In the group allocation of the participants, the principle of double randomization was employed. In experimental research, where a phenomenon is induced by the researcher on purpose, its course is observed in a planned and controlled way. Therefore, the influence of particular factors on the studied parameters can be assessed. Conclusions are drawn on the basis of the discovered relationships; the accuracy of the conclusions is evaluated with a specific probability. In the present study, a significance level of α = 0.05 was assumed, corresponding to a 95% confidence level.
2.3 Parallel group technique The participants were randomly allocated to the experimental group and the control group; the double randomization principle was followed. The first measurement preceded introducing the experimental factor.
The two groups were observed but only the experimental group received the additional stimulus, namely low temperature, i.e. the experimental factor. A second measurement was then performed, allowing to evaluate the changes imposed by the intervention. Owing to the application of a control group, it was possible to state if the reported changes in erythrocyte deformability resulted from the experimental factor - and not from other variables, which were uncontrolled. Although confounding variables are not regarded as essential in the main analysis, they can impact on the research results, leading to effect misinterpretation. Here, exposure to low ambient temperature constituted the experimental factor. The testing environments were different in the two groups (controlled thermal climate chamber in the experimental group and natural outdoor conditions in the control group), which was taken into consideration when interpreting the results.
2.4 Shuttle run test In the current study, cardiorespiratory capacity was determined with the use of an endurance shuttle run test. This is a standardized, incremental protocol commonly applied to provoke progressively increasing cardiorespiratory load. Direct physiological intensity indicators were not recorded but the same protocol was used in both groups in order to obtain comparable external workload progression.
The test started with a steady pace, which equaled 8 km/h. Subsequently, the running speed increased by 0.5 km/h per minute. The subjects ran a 20-m distance back and forth and then touched the finish line with one foot. The running pace was indicated by a beep. The participant finalized the test if they failed to reach the line at a distance of at least 3 m before the beep sound for two successive running sections. The number of completed sections was considered the test result.
2.5 Methods of blood analysis A qualified nurse collected fasting blood samples in 10-ml Vacuette tubes in the morning hours. The staff at the Blood Physiology Laboratory of the Central Research and Development Laboratory, University of Physical Culture in Krakow supervised the procedure, following the applicable standards. Serum indicators were determined in the laboratory of Diagnostyka S.A. in Krakow.
2.6 Morphological assessments The morphological analyses of blood included red blood cell count (RBC) [106/mm3] and hemoglobin (HGB) [g/dl] and were performed with the use of an ABX Micros 60 analyzer (Horiba ABX SAS, Montpellier, France).
2.7 Red blood cell aggregation index A Laser-Assisted Optical Rotational Red Cell Analyzer (Lorrca) (MaxSis Lorrca®, RR Mechatronics, Zwaag, The Netherlands) was applied. The aggregation parameters of aggregation index (AI), amplitude of aggregation (AMP), and half-time kinetics of total aggregation (T½) were evaluated with the Lorrca MaxSis Osmoscan (MaxSis Lorrca®, RR Mechatronics, Zwaag, The Netherlands).
2.8 Biochemical parameters Testosterone concentration [nmol/l] was evaluated with an Alinity I, Abbott immunochemical analyzer. The level of cortisol (μg/dl) was established with chemiluminescence (Abbott, Abbott Park, IL, USA). To determine lactate concentration, the enzymatic method (ARCHITECT c System, Abbott, USA) was used.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polsko, 31-571
- University of Physical Culture
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Healthy men
Exclusion Criteria:
- women
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Single effort in air temperature of -10°C
The body response to exercise performed at reduced (-10°C) temperature
|
the exercise, blood samples
|
|
Experimentální: Single effort in neutral (18°C) condition
The body response to exercise performed at neutral (18°C) temperature
|
the exercise, blood samples
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
blood sampling: AI
Časové okno: twice: before starting the exercise and immediately after finishing it
|
aggregation index
|
twice: before starting the exercise and immediately after finishing it
|
|
blood sampling:AMP
Časové okno: twice: before starting the exercise and immediately after finishing it
|
amplitude of aggregation
|
twice: before starting the exercise and immediately after finishing it
|
|
blood sampling: T1/2
Časové okno: twice: before starting the exercise and immediately after finishing it
|
half-time kinetics of total aggregation
|
twice: before starting the exercise and immediately after finishing it
|
|
blood sampling: RBC
Časové okno: twice: before starting the exercise and immediately after finishing it
|
red blood cells
|
twice: before starting the exercise and immediately after finishing it
|
|
blood sampling: Hb
Časové okno: twice: before starting the exercise and immediately after finishing it
|
hemoglobin
|
twice: before starting the exercise and immediately after finishing it
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Aneta Teległow, Professor, University of Physcial Eduction, Kraków, Poland
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 429/BS/INP/2026 (Jiné číslo grantu/financování: University of Physical Culture)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Zdravý
-
University of ZurichDokončenoOutcome Assessment, Health CareŠvýcarsko
-
University of BernUniversity Hospital Inselspital, BerneDokončenoNeuroscience of Dreaming, HealthŠvýcarsko
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciDokončenoPreventivní zdravotní služby (PREV HEALTH SERV)Spojené státy
-
Queens College, The City University of New YorkNáborZveřejnění článků předložených American Journal of Public HealthSpojené státy
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciZatím nenabírámePreventivní zdravotní služby (PREV HEALTH SERV)Spojené státy
-
University of WashingtonNational Institute of Environmental Health Sciences (NIEHS)Aktivní, ne náborTeplo | Havarijní připravenost | Extrémní teplo | Health Health | Extrémní tepelné vlny | Řízení katastrof | Plánování katastrof | KatastrofySpojené státy
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsDokončenoBolest | Užívání opioidů | Totální náhrada kolena | Aplikace E-healthHolandsko
-
Universidad de ZaragozaNáborProfesionální integrace nově odstupňovaných pracovních terapeutů | Peer Mentorship in Health Professions | Přechod včasného kariéry a profesní identitaŠpanělsko
-
Gümüşhane UniversıtyKaradeniz Technical UniversityDokončenoRegistrováno u Kelkit District State Hospital Home Health Unit | Být pacientem domácí péčeKrocan
-
FIDMAG Germanes HospitalàriesUniversity of BarcelonaDokončenoPorucha duševního zdraví | Duševní zdraví wellness 1 | Role sestry | Care Acceptor, Health | Vztah, sestra pacientaŠpanělsko
Klinické studie na cold
-
Virginia Commonwealth UniversityDokončenoNitroděložní tělísko | Cold CompressSpojené státy
-
Indiana UniversityUniversity of Colorado, Denver; University of Alabama at Birmingham; John D.... a další spolupracovníciZápis na pozvánkuRakovina tlustého střeva | Adenom tlustého střeva | Polyp tlustého střeva | Vroubkovaný polypSpojené státy
-
Stanford UniversityDokončeno
-
National and Kapodistrian University of AthensAktivní, ne náborPolypektomie | Polypy tlustého střevaŘecko
-
University of WashingtonStandard Homeopathic CompanyDokončeno
-
University of WashingtonStandard Homeopathic CompanyDokončeno
-
Washington University School of MedicineNational Center for Advancing Translational Sciences (NCATS)DokončenoVývoj dítěteSpojené státy
-
Marmara UniversityDokončenoOsteoartróza, koleno
-
Afexa Life Sciences IncDokončenoSezónní alergická rýmaKanada
-
Indiana UniversityJohn D. Dingell VA Medical Center; White River Junction Veterans Affairs Medical...DokončenoRakovina tlustého střeva | Adenom tlustého střeva | Polyp tlustého střevaSpojené státy