- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874023
Study to Warm Up and Cool Down Recreationally Active Males Using Different Protocols.
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Passive heating in hot conditions
- Other: Active heating + passive heating in hot conditions
- Other: Active heating in hot conditions
- Other: Active heating at room temperature
- Other: Cool vest
- Other: Damp neck towel combined with arm cool water immersion
- Other: Combination of cooling interventions
- Other: Control in thermoneutral room without cooling
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85004
- Community Services Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy young men exposed to heating and cooling protocols
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.
|
Participants performed seated passive heating in 54C conditions
Participants performed 30 minutes of biking exercise in 43C + 30 min of passive seated heating in 54C conditions.
Participants performed 60 minutes of biking exercise in 43C.
Participants performed active heating through biking exercise for 60 minutes at room temperature.
Cool vest (18°C) with 500 mL (16 fl oz) ice water consumption
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 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
A control with participant sitting in a thermoneutral room (20°C air temperature) without any additional cooling intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During 60 minute of heating intervention, followed by 60 minutes of cooling intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
During 60 minute of heating intervention, followed by 60 minutes of cooling intervention.
|
|
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.
|
During 60 minute of heating intervention, followed by 60 minutes of cooling intervention.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Covering the 60 min of heating and 60 min of cooling resulting in an average sweat rate per hour.
|
|
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.
|
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
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).
|
Continuous measurements during the 60 minute heating intervention, followed by the total duration of cooling to baseline intervention for a maximum of 60 minutes.
|
|
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).
|
Continuous measurements during the 60 minute heating intervention, followed by the total duration of cooling to baseline intervention for a maximum of 60 minutes.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00015072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.