Cryotherapy EffectNCT03776734
Effects of Cold Application on Exercise Performance
A study testing Cryotherapy application in people with Cryotherapy Effect, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Cryotherapy application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCyprus
- Study dates
- 30 Jul 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals with sensory loss
- Individuals with cold hypersensitivity
- Drug users who may influence performance
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Famagusta
İLKER YATAR, MSc. PT, +903926303067, ilker.yatar@emu.edu.tr
ilker yatar, MSc. PT
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cryotherapy Effect
- Being tested
- Cryotherapy application
- Keywords
- precooling, exercise, pulmonary function, isokinetic, lactate
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy applicationOther
Effects of 5-10- 20 minutes cold application on quadriceps muscle
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy application | Experimental | effect of cold application Receives: Other: Cryotherapy application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
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.
Measured: 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.
Secondary outcomes (10)
Muscle strength
Concentric quadriceps muscle torque values will be measured with isokinetic dynamometer as Newton-meter with speed of 60 and 240 degrees in seconds
Measured: 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
Quadriceps muscle endurance values will be measured with isokinetic dynamometer as endurance percentage(%) with speed of 240 degrees in seconds
Measured: 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
Forced expiratory volume in one second as liter (FEV1) will be measured with spirometry test
Measured: 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
Forced vital capacity as liter (FVC) will be measured with spirometry test
Measured: 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.
Peak expiratory flow
Peak expiratory flow as liter in one second (PEF) will be measured with spirometry test
Measured: 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
Forced expiratory flow as liter (FEF25-75%) will be measured with spirometry test
Measured: 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 voluntary ventilation
Maximal voluntary ventilation as liter in one minute (MVV) will be measured with spirometry test
Measured: 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
Maximal inspiration pressure (MIP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.
Measured: 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 expiration pressure
Maximal expiration pressure (MEP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.
Measured: 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
Lactate level will be measured before and after maximal test.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start30 Jul 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker Yatar, Eastern Mediterranean University
- Investigators
- İLKER YATAR, MSc. PT, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776734
- Sponsor's protocol ID
- ETK00-2017-0296
- Status last verified
- Feb 2019
- First submitted
- 9 Nov 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Durations of Cold Application on Respiratory Function, Exercise Capacity and Muscle Performance
- ClinicalTrials.gov ID
- NCT03776734
- Acronym / sponsor ID
- ETK00-2017-0296
- Conditions
- Cryotherapy Effect
- Keywords
- precooling, exercise, pulmonary function, isokinetic, lactate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cryotherapy application | Experimental | Other: Cryotherapy applicationeffect of cold application |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals with sensory loss
- Individuals with cold hypersensitivity
- Drug users who may influence performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy applicationEffects of 5-10- 20 minutes cold application on quadriceps muscle | Other | cryotherapy application |
Primary outcome
Exercise capacity
Time frame: 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.
10 secondary outcomes
Muscle strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Peak expiratory flow
Time frame: 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
Time frame: 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 voluntary ventilation
Time frame: 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
Time frame: 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 expiration pressure
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İLKER YATAR, MSc. PT principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy application in people with Cryotherapy Effect, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İLKER YATAR, MSc. PT (00903926303067, ilker.yatar@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.