- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02016521
Cooling Fabrics and Exercise Performance in Endurance Athletes
August 24, 2015 updated by: Dennis Jensen, Ph.D., McGill University
"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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2W1S4
- McGill University, Dept. of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cooling Fabric
Garment made of 100% nylon fabric consisting of long sleeved shirt and full trouser.
|
Garment made of 100% nylon and consisting of long sleeved shirt and full trouser.
|
|
Placebo Comparator: Placebo Garment
Garment made of 100% polyester consisting of long sleeved shirt and full trouser.
|
Garment made of 100% polyester consisting of long sleeved shirt and full trouser
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
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.
|
Participants will be followed until all study visits are complete, an expected average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
December 15, 2013
First Submitted That Met QC Criteria
December 15, 2013
First Posted (Estimate)
December 20, 2013
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 24, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- A00-M108-13A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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