NCT02016521

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

December 15, 2013

Last Update Submit

August 24, 2015

Conditions

Keywords

ExerciseClothingCore body temperatureSkin TemperaturePerformance

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Participants will be followed until all study visits are complete, an expected average of 2 weeks

Study Arms (2)

Cooling Fabric

EXPERIMENTAL

Garment made of 100% nylon fabric consisting of long sleeved shirt and full trouser.

Other: Cooling Fabric

Placebo Garment

PLACEBO COMPARATOR

Garment made of 100% polyester consisting of long sleeved shirt and full trouser.

Other: Placebo Garment

Interventions

Garment made of 100% nylon and consisting of long sleeved shirt and full trouser.

Cooling Fabric

Garment made of 100% polyester consisting of long sleeved shirt and full trouser

Placebo Garment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University, Dept. of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory

Montreal, Quebec, H2W1S4, Canada

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dennis Jensen, Ph.D.

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 20, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations