- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03776734
Effects of Cold Application on Exercise Performance
Effects of Different Durations of Cold Application on Respiratory Function, Exercise Capacity and Muscle Performance
It is of utmost importance to determine the individual upper limits in the recommended exercises for increasing the level of physical activity and for developing the cardiovascular system. Cardiovascular exercise tests are used in determining the exercise capacity and performance. Cardiovascular exercise tests allow maximal and submaximal loadings to determine the person's body temperature, oxygen consumption, fatigue, interpretation of cardiac responses, and exercise capacity.
Thermal equilibrium is achieved by the activation or inhibition of autonomic and behavioral thermocouples in order to generate, dissipate or protect heat. These thermocouples act together and allow precise control of body temperature, which is arranged in a narrow range.
Under certain conditions, such as body temperature, systemic inflammation, extreme environmental conditions, and exercise performance, it falls outside this narrow range. Metabolic heat production is 15 to 20 times greater than resting during exercise. In exercise performed under hot ambient conditions, the rate of heat production will exceed the rate of heat loss and cause it to rise rapidly before reaching a plateau. The increase due to the exhalation of body heat initiates two autonomous thermodynamics for heat dissipation: sweating and cutaneous vasodilatation. Although both mechanisms help prevent exaggerated increase in body temperature, they cause stress for the cardiovascular system.
Exercise performance and level of physical activity are influenced by individual characteristics such as personality adjustment and mediocre adjustment. Adaptation is defined as adaptation under natural conditions. Robinson showed that the individual salt losses are higher in individuals who exercise in a hot environment and cannot adapt to the temperature, a decrease in both urine and sweat salt contents with temperature compliance. One research has shown that exercise performance is influenced by heat-induced muscle cramps and cardiovascular function disorders due to this significant increase in salt loss. An increase in body temperature caused by exercise can have a negative impact on exercise performance and may lead to the development of conditions associated with increased body temperature.
Although many studies in literature have shown positive effects of performance of pre-exercise cold exercise on performance, there is no consensus on the use of cold applications.
Přehled studie
Detailní popis
In our study, changes that may arise from individual differences will be tried to be controlled using repetitive measurements in the same individuals. Evaluation results will be recorded without any cold application in order to determine the circumstances prior to the application. In the following weeks, doses to both Quadriceps muscles will be recorded immediately after cold application of 5 minutes, 10 minutes and 20 minutes. Each of the applications will be held on the same day of the week and at the same time in 4 consecutive weeks. Nutritional and fluid trains (such as stimulant substances, amount of coffee tea), ambient conditions (temperature and humidity) that may affect individual performance will be recorded. Keeping room conditions under control will benefit from air conditioning. Individuals will be informed about the equipment and test protocol to be used in the tests. A sufficient number of trials will be done before the test so that the participants are familiar with the equipment and test protocol. All assessments will be performed by the same physiotherapist.
Participant Evaluation:
- Body composition will be assessed by height, weight, body fat percentage and skin thickness measurements. (TANİTA and Skinfold measurements)
- Bruce protocol with the aim of determining the exercise capacity (Bruce protocol installed on the treadmill), fatigue (lactate measurement device), heart rate (Polar wireless heart rate index), blood pressure (manual sphygmomanometer), saturated oxygen level (pulse oximetry) and oxygen consumption (metabolic gas analyzer) measurements.
- Respiratory Function Test (Spirometer, FEV1, FVC, FEV1 / FVC, FEF (25-75), PEF, MVV) should be performed for evaluation of respiratory functions.
- Respiratory muscle strength will be assessed by in-mouth pressure measurements (MIP-MEP device) during inhalation and exhalation.
- The application area will be assessed by dual laser infrared non-contact superficial temperature measurement thermometer and general body temperature infrared in-ear thermometer.
- Assessment of muscle strength and muscular endurance will be assessed with an isokinetic dynamometer.
Application Program:
Keeping room conditions, temperature and humidity under control will benefit from air conditioning. Temperature and humidity percentage indicator will be used when room conditions are monitored. Cooled ice packs of gel will be used to cool the quadriceps muscles. The amount of heat of the gel packets, before and after application of the application area, will be recorded by measuring with an infrared non-contact thermometer.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: İLKER YATAR, MSc. PT
- Telefonní číslo: 00903926303067
- E-mail: ilker.yatar@emu.edu.tr
Studijní místa
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-
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Famagusta, Kypr
- Nábor
- Eastern Mediterranean University
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Kontakt:
- İLKER YATAR, MSc. PT
- Telefonní číslo: +903926303067
- E-mail: ilker.yatar@emu.edu.tr
-
Vrchní vyšetřovatel:
- ilker yatar, MSc. PT
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Male, healthy individuals between the ages of 18-25
- individuals without peripheral circulatory disturbances
- Individuals without chronic disease
- Individuals without orthopedic, neurological, cardiopulmonary disturbances that may prevent evaluation and measurement
- individuals who have not exercised regularly in the past six months
Exclusion Criteria:
- Individuals with sensory loss
- Individuals with cold hypersensitivity
- Drug users who may influence performance
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: cryotherapy application
effect of cold application
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Effects of 5-10- 20 minutes cold application on quadriceps muscle
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Exercise capacity
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Oxygen consumption on maximal exercise test (Bruce Protocol) will be assessed with mobile metabolic analyzer system as expended oxygen level per kilogram in one minute (ml/kg/min.) will be measured after cold application.
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Muscle strength
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Concentric quadriceps muscle torque values will be measured with isokinetic dynamometer as Newton-meter with speed of 60 and 240 degrees in seconds
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Muscle endurance
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Quadriceps muscle endurance values will be measured with isokinetic dynamometer as endurance percentage(%) with speed of 240 degrees in seconds
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Forced expiratory volume
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Forced expiratory volume in one second as liter (FEV1) will be measured with spirometry test
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Forced vital capacity
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Forced vital capacity as liter (FVC) will be measured with spirometry test
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Peak expiratory flow
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Peak expiratory flow as liter in one second (PEF) will be measured with spirometry test
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Forced expiratory flow
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Forced expiratory flow as liter (FEF25-75%) will be measured with spirometry test
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Maximal voluntary ventilation
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Maximal voluntary ventilation as liter in one minute (MVV) will be measured with spirometry test
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Maximal inspiration pressure
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Maximal inspiration pressure (MIP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Maximal expiration pressure
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Maximal expiration pressure (MEP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Fatigue
Časové okno: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
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Lactate level will be measured before and after maximal test.
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Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: İLKER YATAR, MSc. PT, Eastern Mediterranean University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
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 identifikační čísla studie
- ETK00-2017-0296
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
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