Cooling FabricsNCT02016521
Cooling Fabrics and Exercise Performance in Endurance Athletes
A study testing Cooling Fabric in people with Cooling Fabrics and Exercise Performance, run by McGill University at 1 site in Canada.
Trial summary
In humans, the primary means of cooling the body during exercise is through the evaporation of sweat from the skin surface. Clothing represents a layer of insulation that hinders the evaporation of sweat from the surface of the skin. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cooling Fabrics, Exercise Performance, Thermoregulation
- What is being tested?
- Cooling Fabric
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jul 2014
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- Non-smoker
- Aged 20-60 years
- Competitive cyclist and/or triathlete competing at the regional, provincial, national and/or international level.
- Maximal rate of oxygen uptake on incremental cycle exercise testing greater than or equal to 60 ml/kg/min.
- Forced expiratory volume in 1 second greater than or equal to 80% predicted.
- Forced expiratory volume in 1 second/forced vital capacity ratio greater than or equal to 70%.
- Women: taking an oral contraceptive for at least 6 months prior to study enrolment.
Who cannot join
- History or presence of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular, metabolic, menstrual cycle and/or sleep related disease/disorder/dysfunction.
- Inability to perform exercise and pulmonary function testing.
- Taking doctor prescribed medication, other than oral contraceptives for women.
- Allergy to lidocaine or its 'caine' derivatives.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University, Dept. of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory
Montreal, Quebec, H2W1S4
About this study
Official title: "Keep Cool": a Randomized Trial on the Effect of Wearing a Garment Made of Cooling Fabrics on Thermoregulatory, Cardiorespiratory, and Perceptual Responses to Exercise in Endurance-trained Athletes
In humans, the primary means of cooling the body during exercise is through the evaporation of sweat from the skin surface. Clothing represents a layer of insulation that hinders the evaporation of sweat from the surface of the skin. It follows that clothing that imposes the least amount of resistance to evaporative heat loss may prove beneficial to the thermoregulatory, physiological and perceptual response to exercise, particularly in elite endurance-trained athletes. Thus, the purpose on this study is to examine the influence of wearing a sportswear garment made of a fabric (100% nylon) with superior evaporative characteristics on detailed thermoregulatory, cardiorespiratory, metabolic and perceptual responses to maximal exercise testing at normal room temperature and relatively humidity in a group of 25 endurance-trained cyclists and triathletes aged 20-60 years. It is hypothesized that wearing a garment made of 100% nylon will improve exercise performance (e.g., exercise endurance time) and that this improvement will reflect improvements in thermoregulatory, cardiorespiratory, metabolic and perceptual responses to exercise. Athletes will be recruited via contact with coaches of the McGill University Cycling and Triathlon teams as well as through contact with coaches of competitive cycling and triathlon teams/training groups in the Montreal and surrounding area. Initial contact will consist of a thorough explanation of the study procedures and pre-screening for the inclusion/exclusion criteria prior to study consent by the Principal Investigator and/or his delegate, either in person or by telephone or email. Eligible participants will visit McGill's Clinical Exercise \& Respiratory Physiology Laboratory on 3 separate occasions over a period of 10-14 days. Visit 1 will include a maximal incremental bicycle exercise test for familiarization purposes and to determine maximal power output (MPO). Visits 2 and 3 will include a constant-power-output bicycle exercise test at 85% MPO under one of two conditions, in randomized order: (1) while wearing a garment made of 100% polyester, i.e., placebo; and (2) while wearing a garment made of 100% nylon, i.e., cooling fabric. At rest and during exercise at visits 2 and 3, detailed assessments of core body temperature will be made using a temperature sensor placed into the esophagus, while skin temperature and other physiological and perceptual parameters will be measured using standard techniques.
- Conditions
- Cooling Fabrics, Exercise Performance, Thermoregulation
- Being tested
- Cooling Fabric, Placebo Garment
- Keywords
- Exercise, Clothing, Core body temperature, Skin Temperature, Performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling FabricOther
Garment made of 100% nylon and consisting of long sleeved shirt and full trouser.
Placebo GarmentOther
Garment made of 100% polyester consisting of long sleeved shirt and full trouser
| Study group | Role | What they receive |
|---|---|---|
| Cooling Fabric | Experimental | Garment made of 100% nylon fabric consisting of long sleeved shirt and full trouser. Receives: Other: Cooling Fabric |
| Placebo Garment | Placebo comparator | Garment made of 100% polyester consisting of long sleeved shirt and full trouser. Receives: Other: Placebo Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise endurance time (EET)
Exercise endurance time (EET) will be defined as the duration of loaded pedalling during constant work rate cycle exercise testing at 85% of each participants maximum incremental power output (in watts).
Measured: Participants will be followed until all study visits are completed, an expected average of 2 weeks
Esophageal temperature (in degrees Celsius) at isotime during exercise
Esophageal temperature, recorded using an esophageal thermistor and estimating core body temperature, averaged over the last 30-secs of the highest equivalent exercise time (isotime) achieved by a given subject during exercise under the two treatment periods.
Measured: Participants will be followed until all study visits are complete, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cooling FabricsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016521
- Sponsor's protocol ID
- A00-M108-13A
- Status last verified
- Aug 2015
- First submitted
- 15 Dec 2013
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Keep Cool": a Randomized Trial on the Effect of Wearing a Garment Made of Cooling Fabrics on Thermoregulatory, Cardiorespiratory, and Perceptual Responses to Exercise in Endurance-trained Athletes
- ClinicalTrials.gov ID
- NCT02016521
- Acronym / sponsor ID
- A00-M108-13A
- Conditions
- Cooling Fabrics, Exercise Performance, Thermoregulation
- Keywords
- Exercise, Clothing, Core body temperature, Skin Temperature, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Dec 2013 (estimated)
- 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.
In humans, the primary means of cooling the body during exercise is through the evaporation of sweat from the skin surface. Clothing represents a layer of insulation that hinders the evaporation of sweat from the surface of the skin. It follows that clothing that imposes the least amount of resistance to evaporative heat loss may prove beneficial to the thermoregulatory, physiological and perceptual response to exercise, particularly in elite endurance-trained athletes. Thus, the purpose on this study is to examine the influence of wearing a sportswear garment made of a fabric (100% nylon) with superior evaporative characteristics on detailed thermoregulatory, cardiorespiratory, metabolic and perceptual responses to maximal exercise testing at normal room temperature and relatively humidity in a group of 25 endurance-trained cyclists and triathletes aged 20-60 years. It is hypothesized that wearing a garment made of 100% nylon will improve exercise performance (e.g., exercise endurance time) and that this improvement will reflect improvements in thermoregulatory, cardiorespiratory, metabolic and perceptual responses to exercise. Athletes will be recruited via contact with coaches of the McGill University Cycling and Triathlon teams as well as through contact with coaches of competitive cycling and triathlon teams/training groups in the Montreal and surrounding area. Initial contact will consist of a thorough explanation of the study procedures and pre-screening for the inclusion/exclusion criteria prior to study consent by the Principal Investigator and/or his delegate, either in person or by telephone or email. Eligible participants will visit McGill's Clinical Exercise \& Respiratory Physiology Laboratory on 3 separate occasions over a period of 10-14 days. Visit 1 will include a maximal incremental bicycle exercise test for familiarization purposes and to determine maximal power output (MPO). Visits 2 and 3 will include a constant-power-output bicycle exercise test at 85% MPO under one of two conditions, in randomized order: (1) while wearing a garment made of 100% polyester, i.e., placebo; and (2) while wearing a garment made of 100% nylon, i.e., cooling fabric. At rest and during exercise at visits 2 and 3, detailed assessments of core body temperature will be made using a temperature sensor placed into the esophagus, while skin temperature and other physiological and perceptual parameters will be measured using standard techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling Fabric | Experimental | Other: Cooling FabricGarment made of 100% nylon fabric consisting of long sleeved shirt and full trouser. |
| Placebo Garment | Placebo comparator | Other: Placebo GarmentGarment made of 100% polyester consisting of long sleeved shirt and full trouser. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or Female
- Non-smoker
- Aged 20-60 years
- Competitive cyclist and/or triathlete competing at the regional, provincial, national and/or international level.
- Maximal rate of oxygen uptake on incremental cycle exercise testing greater than or equal to 60 ml/kg/min.
Key exclusion criteria (4 listed)
- History or presence of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular, metabolic, menstrual cycle and/or sleep related disease/disorder/dysfunction.
- Inability to perform exercise and pulmonary function testing.
- Taking doctor prescribed medication, other than oral contraceptives for women.
- Allergy to lidocaine or its 'caine' derivatives.
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 |
|---|---|---|
| Cooling FabricGarment made of 100% nylon and consisting of long sleeved shirt and full trouser. | Other | Cooling Fabric |
| Placebo GarmentGarment made of 100% polyester consisting of long sleeved shirt and full trouser | Other | Placebo Garment |
Primary outcome
Exercise endurance time (EET)
Time frame: Participants will be followed until all study visits are completed, an expected average of 2 weeks
Exercise endurance time (EET) will be defined as the duration of loaded pedalling during constant work rate cycle exercise testing at 85% of each participants maximum incremental power output (in watts).
Esophageal temperature (in degrees Celsius) at isotime during exercise
Time frame: Participants will be followed until all study visits are complete, an expected average of 2 weeks
Esophageal temperature, recorded using an esophageal thermistor and estimating core body temperature, averaged over the last 30-secs of the highest equivalent exercise time (isotime) achieved by a given subject during exercise under the two treatment periods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill UniversityLink provided by the sponsor.
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.
Dennis Jensen, Ph.D. principal investigator
McGill 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 Cooling Fabric in people with Cooling Fabrics and Exercise Performance, run by McGill University at 1 site in Canada.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 26 Aug 2015. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise endurance time (EET) (time frame: Participants will be followed until all study visits are completed, an expected average of 2 weeks). The study lists 2 primary outcomes in all. 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 26 Aug 2015.