Development of an Active Heat Dissipation Device Based on Thermoelectric Cooling Technology: Aiming to Improve Endurance Sports Performance (DAHDD-TCT)

April 13, 2026 updated by: Ayesha Areeba, Kaohsiung Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Sanmin
      • Kaohsiung City, Sanmin, Taiwan, 807
        • Cooling Vest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Pre-Cooling with TEC Vest

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.
Device: TEC Vest

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.
Experimental: No Pre-Cooling (Without Vest)

Arm 2: No Pre-Cooling

Participants complete the same exercise trial without any cooling intervention (no vest).
Other: 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.
Experimental: Pre-Cooling with Water Cooled Vest

Pre-Cooling with Water Cooled Vest

Participants receive pre-cooling using a water cooled vest for 30 mins prior to the exercise trial.
Device: Water Cooled Vest

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Guo LY Professor and Dean of College of Health Sciences, P.hD, Department of Sports Medicine, Kaohsiung Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-F(II)-20220046
  • KMUHIRB-F(II)-202 20046 (Other Identifier: Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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