Heat StrokeDAHDD-TCTNCT07539714
Development of an Active Heat Dissipation Device Based on Thermoelectric Cooling Technology: Aiming to Improve Endurance Sports Performance
A study testing TEC Vest, No Pre-Cooling (Without Vest) and Water Cooled Vest in people with Heat Stroke, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This project investigates the effectiveness of pre-exercise active cooling using a temperature-controlled cooling vest in reducing heat-related physiological strain during endurance-type aerobic exercise in non-regularly trained ("weekend") athletes under hot and humid environmental conditions. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke
- What is being tested?
- TEC Vest, No Pre-Cooling (Without Vest) and Water Cooled Vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-50 years.
- In the past 6 months, endurance exercise less than three times per week, 40-60 min each session.
- No cardiovascular, metabolic (e.g., diabetes), or neurological disorders, and no diseases affecting vascular regulation.
- No medication affecting vascular tone within the last 3 months.
- No major musculoskeletal injuries or disorders affecting performance within the last 3 months.
Who cannot join
- • Diabetes, hypertension, or peripheral vascular disease.
- Long-term work in hot environments.
- BMI > 30 kg/m², smoking, or heavy alcohol use.
- Allergic reactions triggered by heat or cold (e.g., hives).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heat Acclimation and Innovative Cooling Systems: Optimizing Athletic Performance and Reducing Heat-Induced Performance Impairments in Hot Environments Under Climate Change Conditions
This project investigates the effectiveness of pre-exercise active cooling using a temperature-controlled cooling vest in reducing heat-related physiological strain during endurance-type aerobic exercise in non-regularly trained ("weekend") athletes under hot and humid environmental conditions. Because these individuals often lack sufficient heat-acclimation training, they are at increased risk of excessive thermal stress, cardiovascular overload, and heat-related disorders during prolonged exercise.
Using a controlled laboratory design, participants will perform moderate-intensity endurance exercise in a simulated hot environment, with or without pre-cooling intervention. Peripheral circulation and thermoregulatory responses will be assessed through laser Doppler flowmetry based skin blood-flow analysis and infrared thermography, alongside heart rate and perceived exertion measures.
The study aims to clarify how active pre-cooling influences vascular regulation, sympathetic activity, skin temperature distribution, and exercise tolerance, and to evaluate its potential as a practical, non-fatiguing alternative to heat-acclimation training. The findings are expected to provide evidence-based guidance for reducing heat strain and improving exercise safety and comfort in recreational endurance athletes exercising in hot climates.
Read the detailed description
The primary aim of this study is to investigate the effects of pre-exercise active cooling using a temperature-controlled vest on peripheral vascular regulation mechanisms in non-regular endurance exercisers under hot environmental conditions. Specifically, this study seeks to quantify how pre-cooling modulates skin blood-flow dynamics, sympathetic nervous system activity, endothelial function, and myogenic vascular control, as assessed through frequency-domain analysis of laser Doppler flowmetry signals, before and after endurance-type aerobic exercise. By characterizing these microcirculatory responses alongside changes in skin-surface temperature measured via infrared thermography, the study aims to elucidate the physiological pathways through which active pre-cooling attenuates thermal strain and cardiovascular load during exercise in the heat.
- Conditions
- Heat Stroke
- Being tested
- TEC Vest, No Pre-Cooling (Without Vest), Water Cooled Vest
- Keywords
- Active Cooling Device
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEC VestDevice
Intervention 1: Active Pre-Cooling Vest
Type: Device (active cooling garment)
Timing: 30 minutes before exercise (pre-cooling period)
Procedure: Participants wear the temperature-controlled vest in a hot/humid lab setting before the endurance aerobic exercise test.
Purpose: Reduce thermal strain and cardiovascular load; improve comfort; modulate peripheral circulation responses.
No Pre-Cooling (Without Vest)Other
Intervention 2: No Pre-Cooling Without Vest Type: No intervention / usual condition Timing: 30 min Duration Procedure: Participants rest quietly for the same pre-exercise duration without wearing a cooling vest, then complete the identical warm-up and exercise protocol.
Water Cooled VestDevice
Type: Device (active cooling garment)
Timing: 30 minutes before exercise (pre-cooling period)
Procedure: Participants wear the water cooled vest in a hot/humid lab setting before the endurance aerobic exercise test.
Purpose: Reduce thermal strain and cardiovascular load; improve comfort; modulate peripheral circulation responses.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pre-Cooling with TEC Vest | Experimental | Arm 1: Pre-Cooling with TEC Vest
Participants receive pre-cooling using a temperature-controlled cooling vest (tec) for 30 mins prior to the exercise trial. Receives: Device: TEC Vest |
| No Pre-Cooling (Without Vest) | Experimental | Arm 2: No Pre-Cooling
Participants complete the same exercise trial without any cooling intervention (no vest). Receives: Other: No Pre-Cooling (Without Vest) |
| Pre-Cooling with Water Cooled Vest | Experimental | Pre-Cooling with Water Cooled Vest
Participants receive pre-cooling using a water cooled vest for 30 mins prior to the exercise trial. Receives: Device: Water Cooled Vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Measured: During a single laboratory visit lasting approx. 40 minutes: baseline immediately before the pre cooling period,immediately after 30 minutes of pre cooling,immediately after the 5 minute exercise bout, and immediately after the 5 minute seated cool down.
Temperature
Measured: During a single laboratory visit lasting approx.40 minutes: baseline immediately before the pre cooling period, immediately after 30 minutes of pre cooling,immediately after the 5 minute exercise bout, and immediately after the 5 minute seated cool down.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Areeba, Kaohsiung Medical University
- Investigators
- Guo LY Professor and Dean of College of Health Sciences, P.hD, Study chair, Department of Sports Medicine, Kaohsiung Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539714
- Sponsor's protocol ID
- KMUHIRB-F(II)-20220046
- Other IDs
- KMUHIRB-F(II)-202 20046
- Acronym
- DAHDD-TCT
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Acclimation and Innovative Cooling Systems: Optimizing Athletic Performance and Reducing Heat-Induced Performance Impairments in Hot Environments Under Climate Change Conditions
- ClinicalTrials.gov ID
- NCT07539714
- Acronym / sponsor ID
- DAHDD-TCT / KMUHIRB-F(II)-20220046
- Conditions
- Heat Stroke
- Keywords
- Active Cooling Device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project investigates the effectiveness of pre-exercise active cooling using a temperature-controlled cooling vest in reducing heat-related physiological strain during endurance-type aerobic exercise in non-regularly trained ("weekend") athletes under hot and humid environmental conditions. Because these individuals often lack sufficient heat-acclimation training, they are at increased risk of excessive thermal stress, cardiovascular overload, and heat-related disorders during prolonged exercise.
Using a controlled laboratory design, participants will perform moderate-intensity endurance exercise in a simulated hot environment, with or without pre-cooling intervention. Peripheral circulation and thermoregulatory responses will be assessed through laser Doppler flowmetry based skin blood-flow analysis and infrared thermography, alongside heart rate and perceived exertion measures.
The study aims to clarify how active pre-cooling influences vascular regulation, sympathetic activity, skin temperature distribution, and exercise tolerance, and to evaluate its potential as a practical, non-fatiguing alternative to heat-acclimation training. The findings are expected to provide evidence-based guidance for reducing heat strain and improving exercise safety and comfort in recreational endurance athletes exercising in hot climates.
Detailed description
The primary aim of this study is to investigate the effects of pre-exercise active cooling using a temperature-controlled vest on peripheral vascular regulation mechanisms in non-regular endurance exercisers under hot environmental conditions. Specifically, this study seeks to quantify how pre-cooling modulates skin blood-flow dynamics, sympathetic nervous system activity, endothelial function, and myogenic vascular control, as assessed through frequency-domain analysis of laser Doppler flowmetry signals, before and after endurance-type aerobic exercise. By characterizing these microcirculatory responses alongside changes in skin-surface temperature measured via infrared thermography, the study aims to elucidate the physiological pathways through which active pre-cooling attenuates thermal strain and cardiovascular load during exercise in the heat.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pre-Cooling with TEC Vest | Experimental | Device: TEC VestArm 1: Pre-Cooling with TEC Vest Participants receive pre-cooling using a temperature-controlled cooling vest (tec) for 30 mins prior to the exercise trial. |
| No Pre-Cooling (Without Vest) | Experimental | Other: No Pre-Cooling (Without Vest)Arm 2: No Pre-Cooling Participants complete the same exercise trial without any cooling intervention (no vest). |
| Pre-Cooling with Water Cooled Vest | Experimental | Device: Water Cooled VestPre-Cooling with Water Cooled Vest Participants receive pre-cooling using a water cooled vest for 30 mins prior to the exercise trial. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-50 years.
- In the past 6 months, endurance exercise less than three times per week, 40-60 min each session.
- No cardiovascular, metabolic (e.g., diabetes), or neurological disorders, and no diseases affecting vascular regulation.
- No medication affecting vascular tone within the last 3 months.
- No major musculoskeletal injuries or disorders affecting performance within the last 3 months.
Key exclusion criteria (4 listed)
- • Diabetes, hypertension, or peripheral vascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEC VestIntervention 1: Active Pre-Cooling Vest Type: Device (active cooling garment) Timing: 30 minutes before exercise (pre-cooling period) Procedure: Participants wear the temperature-controlled vest in a hot/humid lab setting before the endurance aerobic exercise test. Purpose: Reduce thermal strain and cardiovascular load; improve comfort; modulate peripheral circulation responses. | Device | Arm 1: Pre-Cooling with TEC Vest |
| No Pre-Cooling (Without Vest)Intervention 2: No Pre-Cooling Without Vest Type: No intervention / usual condition Timing: 30 min Duration Procedure: Participants rest quietly for the same pre-exercise duration without wearing a cooling vest, then complete the identical warm-up and exercise protocol. | Other | No Pre-Cooling (Without Vest) |
| Water Cooled VestType: Device (active cooling garment) Timing: 30 minutes before exercise (pre-cooling period) Procedure: Participants wear the water cooled vest in a hot/humid lab setting before the endurance aerobic exercise test. Purpose: Reduce thermal strain and cardiovascular load; improve comfort; modulate peripheral circulation responses. | Device | Pre-Cooling with Water Cooled Vest |
Primary outcome
Heart Rate
Time frame: During a single laboratory visit lasting approx. 40 minutes: baseline immediately before the pre cooling period,immediately after 30 minutes of pre cooling,immediately after the 5 minute exercise bout, and immediately after the 5 minute seated cool down.
Temperature
Time frame: During a single laboratory visit lasting approx.40 minutes: baseline immediately before the pre cooling period, immediately after 30 minutes of pre cooling,immediately after the 5 minute exercise bout, and immediately after the 5 minute seated cool down.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo LY Professor and Dean of College of Health Sciences, P.hD study chair
Department of Sports Medicine, Kaohsiung Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEC Vest, No Pre-Cooling (Without Vest) and Water Cooled Vest in people with Heat Stroke, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: During a single laboratory visit lasting approx. 40 minutes: baseline immediately before the pre cooling period,immediately after 30 minutes of pre cooling,immediately after the 5 minute exercise bout, and immediately after the 5 minute seated cool down.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.