NCT06874023

Brief Summary

The objective of this study was to examine the impact of four single-bout heating and cooling strategies on warming up and cooling down core body temperature. Heating strategies included: Passive heating in a hot environment (60 min), Active heating (30 min) + passive heating (30 min) in a hot environment, Active heating(60 min) in a hot environment, and Active heating (60 min) at room temperature. Cooling strategies to reduce body core temperature to baseline included: Cool vest (18°C) , Damp neck towel (24°C) combined with arm (i.e. hand, forearm and half of upper arm) cool water immersion (15°C), Combination of both, A control with participant sitting in a thermoneutral room (20°C air temperature) without any additional cooling intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 5, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

HeatAdaptationPassive heating

Outcome Measures

Primary Outcomes (1)

  • Body core temperature

    A portable telemetry system (E-Celsius, BodyCAP, Hérouville Saint-Clair, France) for temperature sensor capsule, with an accuracy of +/- 0.2°C, was used to measure body core temperature.

    During 60 minute of heating intervention, followed by 60 minutes of cooling intervention.

Secondary Outcomes (2)

  • Skin temperature

    During 60 minute of heating intervention, followed by 60 minutes of cooling intervention.

  • Heart rate

    During 60 minute of heating intervention, followed by 60 minutes of cooling intervention.

Other Outcomes (4)

  • Sweat rate

    Covering the 60 min of heating and 60 min of cooling resulting in an average sweat rate per hour.

  • Urine specific gravity

    Pre (within 30 min before heating) and post heating (within 5 min after finishing heating) and cooling interventions (within 5 min after finishing cooling).

  • Environmental temperature

    Continuous measurements during the 60 minute heating intervention, followed by the total duration of cooling to baseline intervention for a maximum of 60 minutes.

  • +1 more other outcomes

Study Arms (1)

Healthy young men exposed to heating and cooling protocols

OTHER

All participants underwent four times a heating protocol separated by at least one week, and during these days after undergoing the heating protocol they also participated in a protocol aiming to cool down their body temperature. Each of the four heating and cooling interventions are described as interventions.

Other: Passive heating in hot conditionsOther: Active heating + passive heating in hot conditionsOther: Active heating in hot conditionsOther: Active heating at room temperatureOther: Cool vestOther: Damp neck towel combined with arm cool water immersionOther: Combination of cooling interventionsOther: Control in thermoneutral room without cooling

Interventions

Participants performed seated passive heating in 54C conditions

Healthy young men exposed to heating and cooling protocols

Participants performed 30 minutes of biking exercise in 43C + 30 min of passive seated heating in 54C conditions.

Healthy young men exposed to heating and cooling protocols

Participants performed 60 minutes of biking exercise in 43C.

Healthy young men exposed to heating and cooling protocols

Participants performed active heating through biking exercise for 60 minutes at room temperature.

Healthy young men exposed to heating and cooling protocols

Cool vest (18°C) with 500 mL (16 fl oz) ice water consumption

Healthy young men exposed to heating and cooling protocols

Damp neck towel (24°C) combined with arm (i.e. hand, forearm and half of upper arm) cool water immersion (15°C) and 500 mL (16 fl oz) ice water consumption

Healthy young men exposed to heating and cooling protocols

Combination of cool vest (18°C), damp neck towel (24°C) with arm cool water immersion (15°C), and 500 mL (16 fl oz) ice water consumption

Healthy young men exposed to heating and cooling protocols

A control with participant sitting in a thermoneutral room (20°C air temperature) without any additional cooling intervention.

Healthy young men exposed to heating and cooling protocols

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • self-reported healthy
  • non-smoking
  • uninjured
  • active (training five to ten hours per week)

You may not qualify if:

  • Participants were screened for fitness using the Physical Activity Readiness Questionnaire (PAR-Q): scoring one or more items as a yes.
  • Contraindications to use a body core temperature sensor capsule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Services Building

Tempe, Arizona, 85004, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Participants performed 4 arms in non-random order (i.e. passive heating, exercise in the heat + passive heating, exercise in the heat, exercise at room temperature), followed by randomized cooling interventions (i.e. a cool slush and one of the three cooling treatments: 1) cool vest, 2) lower arm cool water immersion with cold towel in the neck, 3) combination of 1+2) or heaving no cooling intervention at room temperature with thermoneutral water only).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 13, 2025

Study Start

September 14, 2020

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations