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Completed

NCT Number: NCT06874023

Study to Warm Up and Cool Down Recreationally Active Males Using Different Protocols.

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Community Services Building

Tempe, Arizona, 85004, United States

About this study

This semi-randomized crossover control trial was performed between September and October 2020. Data collection took place over the course of 5-weeks with 10 subjects, with one data collection session with all subjects per week (hence, 40 trials total). Baseline gastrointestinal temperature (Tgi) was recorded, and the final Tgi at the end of the heating intervention (Part I), was used as the starting temperature for the current study (Part II).

Part I focused on assessing the efficacy of different heating strategies (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), aiming to reach a core temperature of 38.5°C during a 60-minute period.

Part II focused on cooling the body to a pre-exercise baseline core temperature. Cooling strategies consisted of: 1) Cool vest (18°C) with 500 mL (16 fl oz) ice water consumption, 2) 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 3) 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 or 4) A control with participant sitting in a thermoneutral room (20°C air temperature) without any additional cooling intervention. Thermoneutral water was consumed ad libitum for all interventions in addition to the 500 mL (16 fl oz) ice water consumption for experimental trials (#1-3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Passive heating in hot conditions

Other

Participants performed seated passive heating in 54C conditions

Active heating + passive heating in hot conditions

Other

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

Active heating in hot conditions

Other

Participants performed 60 minutes of biking exercise in 43C.

Active heating at room temperature

Other

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

Cool vest

Other

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

Damp neck towel combined with arm cool water immersion

Other

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

Combination of cooling interventions

Other

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

Control in thermoneutral room without cooling

Other

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

Primary outcomes

  1. Body core temperature

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

    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.

Secondary outcomes

  1. Skin temperature

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

    Wireless temperature sensors (iButton DS1+2L, Dallas Semiconductor Corp, USA), with an accuracy of ± 0.5°C and a resolution of 0.0625°C, were used to measure Tsk at 20-second intervals. Sensors at four locations (neck, right shoulder, and right shin with all 0.28 weighted coefficient, and left hand with a coefficient of 0.16 to calculate weighted Tsk outcome) as suggested per ISO protocol, held in place at the skin using Opsite transparent film (Opsite Flexigrid, Smith & Nephew Medical Limited, Hull, England).

  2. Heart rate

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

    Participants wore an elastic chest strap device (Bioharness-3, Zephyr Technology, Annapolis, MD, USA), measuring HR in beats per minute (bpm) at 1-second intervals.

Other outcomes

  1. Sweat rate

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

    To determine sweat rate fluid intake, body mass, and urine volume was collected and sweat rate was calculated.

  2. Urine specific gravity

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

    As a marker for urine concentration urine specific gravity (USG) was measured.

  3. Environmental temperature

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

    During each intervention, the ambient temperature of each testing condition were logged every minute (Kestrel 5400 Heat Stress Tracker with wind vane, Nielsen-Kellerman, Boothwyn, PA, USA).

  4. Relative humidity

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

    During each intervention, the relative humidity of each testing condition were logged every minute (Kestrel 5400 Heat Stress Tracker with wind vane, Nielsen-Kellerman, Boothwyn, PA, USA).

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Warm Up and Cool Down Study: Various Combined Active and Passive Isothermic Heating Protocols, Followed by Different Cooling Protocols, to Increase and Lower Body Core Temperature.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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