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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cooling Fabric
Garment made of 100% nylon fabric consisting of long sleeved shirt and full trouser.
Other: Cooling Fabric
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.
Other: Placebo Garment
Garment made of 100% polyester consisting of long sleeved shirt and full trouser

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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