NCT07781605

Brief Summary

Little is known about how children and youth regulate body temperature during exercise across different environmental temperatures compared with young adults, including whether differences in whole-body heat exchange contribute to their responses. The goal of this clinical trial is to determine how ambient temperature affects thermoregulation during exercise in boys and girls aged 9-16 years compared with young adult men and women aged 20-25 years. Participants will complete four study visits at ambient temperatures of 22°C (Celsius; 72°F, Fahrenheit), 26°C (79°F), 31°C (88°F), and 36°C (97°F), while exercising at the same moderate-intensity metabolic heat production of 160 W/m² (W = watts, m = meters). During each visit, participants will complete four 15-minute periods of exercise (exercise bouts 1, 2, 3 and 4 respectively) separated by 15-minute rest periods. Testing will be performed in a whole-body air calorimeter, a specialized chamber that precisely measures heat lost through evaporation and dry heat exchange and the amount of heat stored in the body. These measurements, together with core temperature and heart rate, will allow researchers to determine how increasing ambient temperature affects the body's ability to lose heat and whether these responses differ between children and youth and young adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jul 2026Jun 2027

Study Start

First participant enrolled

July 19, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 18, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

ThermoregulationHeat lossHeat toleranceHeat strainPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Core temperature

    Core temperature indexed by visceral (telemetry pill) temperature

    End of each of the four 15 minutes exercise bouts (average of last 5 minutes)

Secondary Outcomes (8)

  • Evaporative heat loss

    End of each of the four 15 minutes exercise bouts (average of last 5 minutes)

  • Dry heat loss

    End of each of the four 15 minutes exercise bouts (average of last 5 minutes)

  • Whole-body total heat loss

    End of each of the four 15 minutes exercise bouts (average of last 5 minutes)

  • Body heat storage

    Change from start to end of exercise for each of the four 15 minutes exercise bouts

  • Skin temperature

    End of each of the four 15 minutes exercise bouts (average of last 5 minutes)

  • +3 more secondary outcomes

Study Arms (4)

Exercise at 22°C

EXPERIMENTAL

Participants will complete intermittent moderate-intensity exercise at an ambient temperature of 22°C (celsius; 72°F, fahrenheit). Exercise will be performed at a metabolic heat production of 160 W/m² (W = watts, m = meters) and will consist of four 15-minute exercise periods separated by 15-minute rest periods. Exercise workload will be individually adjusted to achieve the prescribed metabolic heat production.

Other: Exercise at 22°C

Exercise at 26°C

EXPERIMENTAL

Participants will complete intermittent moderate-intensity exercise at an ambient temperature of 26°C (79°F). Exercise will be performed at a metabolic heat production of 160 W/m² and will consist of four 15-minute exercise periods separated by 15-minute rest periods. Exercise workload will be individually adjusted to achieve the prescribed metabolic heat production.

Other: Exercise at 26°C

Exercise at 31°C

EXPERIMENTAL

Participants will complete intermittent moderate-intensity exercise at an ambient temperature of 31°C (88°F). Exercise will be performed at a metabolic heat production of 160 W/m² and will consist of four 15-minute exercise periods separated by 15-minute rest periods. Exercise workload will be individually adjusted to achieve the prescribed metabolic heat production.

Other: Exercise at 31°C

Exercise at 36°C

EXPERIMENTAL

Participants will complete intermittent moderate-intensity exercise at an ambient temperature of 36°C (97°F). Exercise will be performed at a metabolic heat production of 160 W/m² and will consist of four 15-minute exercise periods separated by 15-minute rest periods. Exercise workload will be individually adjusted to achieve the prescribed metabolic heat production.

Other: Exercise at 36°C

Interventions

Participants complete intermittent exercise at a metabolic heat production of 160 W/m² in an ambient temperature of 22°C (72°F).

Exercise at 22°C

Participants complete intermittent exercise at a metabolic heat production of 160 W/m² in an ambient temperature of 26°C (79°F).

Exercise at 26°C

Participants complete intermittent exercise at a metabolic heat production of 160 W/m² in an ambient temperature of 31°C (88°F).

Exercise at 31°C

Participants complete intermittent exercise at a metabolic heat production of 160 W/m² in an ambient temperature of 36°C (97°F).

Exercise at 36°C

Eligibility Criteria

Age9 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy male or female.
  • Aged 9-16 years or 20-25 years.
  • Habitually active, defined as participating in regular physical activity at least 3 times per week for at least 20 minutes per session over the previous 6 months.
  • Able to understand and communicate in English or French.
  • For participants younger than 18 years, written parental or guardian consent and participant assent are required.

You may not qualify if:

  • Acute illness at the time of testing (e.g., cold, flu, or infection).
  • History of a chronic medical condition that may affect thermoregulation, cardiovascular function, or exercise capacity (e.g., cardiovascular disease, metabolic disorders, respiratory disease including asthma requiring regular medication, or neurological disorders).
  • Use of medications known to affect thermoregulation, hydration status, or cardiovascular responses.
  • History of heat-related illness (e.g., heat exhaustion or heat stroke).
  • Digestive abnormalities or gastrointestinal conditions that may contraindicate ingestion of a telemetry pill.
  • Any condition that, in the opinion of the investigators, would compromise participant safety or the integrity of the data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

MeSH Terms

Conditions

Body Temperature ChangesHeat Stress DisordersMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesBehavior

Central Study Contacts

Glen P Kenny, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 24, 2026

Study Start

July 19, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations