- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04241900
Effect of Aging and Aerobic Fitness Level on Heat Dissipation
Effect of Aging and Aerobic Fitness Level on Heat Dissipation in Neutral Conditions
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
All trials were conducted to indoor gyms with the same environmental temperature and relative humidity, 26 - 30oC and 40-50% respectively, to ensure no difference in body temperature were due to the external thermal stress. The participants were instructed to refrain from intense exercise as well as alcohol and caffeine consumption for 24 hours prior to experimental trial and to had a light meal 2h before their arrival.
Upon arrival, participants would have to wear running shoes, light and short running shorts and light cotton socks. Participants received comprehensive instructions about the shuttle run test and the whole process of measurements. Firstly participants answered the International Physical Activity Questionnaire (IPAQ). Thereafter, anthropometrics data (weight and height) were evaluated as well as the body temperature in external ear canal and axillary. All participants followed five minutes warming up and then performed to 20 m shuttle run test until their volitional limit. Once the participants could no longer run, the test was over and the number of laps was recorded. After the end of the shuttle run, were evaluated the body temperature and the weight of each participants. No fluids consumptions were permitted until the second weighing. They were weighed twice, at baseline and at the end of the running test with a precision weight scale (Kern DE 150K2D, KERN & SOHN GmbH, Balingen, Germany).
Environmental data including air temperature and relative humidity were measured continuously using a portable weather station (LCD Digital Temperature & Humidity Meter HTC-1). The weather station was placed 1 meter above the ground according to the manufacturer's guidelines.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Thessaly
-
Trikala, Thessaly, Řecko, 42100
- Department of Exercise Science, University of Thessaly
-
Tríkala, Thessaly, Řecko, 42100
- FAME Lab, Department of Exercise Science, University of Thessaly
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Healthy children and adults
Exclusion Criteria:
- Diagnosed chronic medical condition;
- Symptoms of acute illness;
- Recent (past 4 weeks) usage of medications known to affect the circulatory system, the thyroid, the pituitary function, or the metabolic status
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Shuttle run test
At the shuttle run test, participants were required to run between two lines 20 meters apart, while keeping pace with audio signals emitted from a pre-recorded CD.
The frequency of the sound signals increases in such way that running speed was increased by 0.5 km h-1 each minute from the starting speed 8.5 km h-1.
|
At the shuttle run test, participants were required to run between two lines 20 meters apart, while keeping pace with audio signals emitted from a pre-recorded CD.
The frequency of the sound signals increases in such way that running speed was increased by 0.5 km h-1 each minute from the starting speed 8.5 km h-1.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Aerobic fitness level
Časové okno: Through study completion (a shuttle run test), an average of 15 minutes
|
Aerobic fitness level was defined by peak oxygen uptake (VO2peak).
VO2peak was determined by a 20m shuttle run test.
The number of the last announced stage and the equivalent maximal speed from participants' performance were used for its VO2peak estimation
|
Through study completion (a shuttle run test), an average of 15 minutes
|
Change from baseline ear canal temperature
Časové okno: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Ear canal temperature was recorded twice, at baseline and at the end of the shuttle run test (three times each at the left ear and recorded the mean value), using ear thermometer (IR100, MicrolifeSwitzerland)
|
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Change from baseline axillary temperature
Časové okno: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Axillary temperature was recorded twice, at baseline and at the end of the shuttle run test, using the electronic digital thermometer (EcoTemp, OMRON, Japan)
|
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Physical activity levels
Časové okno: Once before the shuttle run test
|
Physical activity of the subject in a usual week was recorded via International Physical Activity Questionnaire.
Scores include steps/day and METs/week, with no lower and upper limit
|
Once before the shuttle run test
|
Change from baseline body weight
Časové okno: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Weight was recorded twice, at baseline and at the end of the shuttle run test, using a precision weight scale (Kern DE 150K2D, KERN & SOHN GmbH, Balingen, Germany
|
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Change from baseline whole Body Sweat Rate
Časové okno: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Whole Body Sweat Rate was determined by the difference of the pre-test and post-test weight of the participants
|
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
|
Air temperature
Časové okno: Up to 30 minutes, during a one complete shuttle run test
|
Air temperature was measured continuously using a portable weather station (LCD Digital Temperature & Humidity Meter HTC-1placed) 1 meter above the ground according to the manufacturer's guidelines
|
Up to 30 minutes, during a one complete shuttle run test
|
Relative humidity
Časové okno: Up to 30 minutes, during a one complete shuttle run test
|
Relative humidity was measured continuously using a portable weather station (LCD Digital Temperature & Humidity Meter HTC-1) placed 1 meter above the ground according to the manufacturer's guidelines
|
Up to 30 minutes, during a one complete shuttle run test
|
Spolupracovníci a vyšetřovatelé
Sponzor
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
- 10. Aging and heat loss
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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 Shuttle run test
-
Lite Run Inc.Minneapolis Veterans Affairs Medical Center; TREATNeznámýMrtvice | Poranění mozku, traumatické | Poranění míchy | Poruchy chůze, neurologické
-
Northwestern UniversityChicago Run; American Academy of Cerebral Palsy and Developmental Medicine; Spencer...Zápis na pozvánkuDětská mozková obrna | Zpoždění vývoje hrubé motoriky | Poruchy motorických dovedností | Myelomeningokéla | ArtrogrypózaSpojené státy
-
Gillette Children's Specialty HealthcareLite Run Inc.DokončenoDětská mozková obrna | Neurologická porucha | Spina Bifida | Chromozomová abnormalitaSpojené státy
-
Universidade Cidade de Sao PauloDokončenoTočivý momentBrazílie
-
University College CopenhagenUniversity of Copenhagen; UCL University College, DenmarkNáborAKTIVNÍ ŠKOLA - Vliv nových přístupů ke zvýšení fyzické aktivity u školních dětí na akademický výkonStudijní výsledkyDánsko
-
AstraZenecaDokončenoRefluxní choroba jícnu (GERD)Spojené státy, Francie, Polsko, Německo
-
Yonsei UniversityDokončenoPostprandiální hyperglykémie
-
University of FloridaDokončenoParkinsonova nemoc (PD)Spojené státy
-
Clinical Nutrition Research Centre, SingaporeDokončeno