- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539714
Development of an Active Heat Dissipation Device Based on Thermoelectric Cooling Technology: Aiming to Improve Endurance Sports Performance (DAHDD-TCT)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sanmin
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Kaohsiung City, Sanmin, Taiwan, 807
- Cooling Vest
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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. |
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). |
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. |
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
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.
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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
Sponsor
Investigators
- 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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID 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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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