NCT07539714

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026May 2027

Study Start

First participant enrolled

February 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

February 10, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Active Cooling Device

Outcome Measures

Primary Outcomes (2)

  • Heart Rate

    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

    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.

Study Arms (3)

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.

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).

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.

Device: Water Cooled Vest

Interventions

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.

Arm 1: Pre-Cooling with TEC 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.

No Pre-Cooling (Without 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.

Pre-Cooling with Water Cooled Vest

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooling Vest

Kaohsiung City, Sanmin, 807, Taiwan

Location

MeSH Terms

Conditions

Heat Stroke

Condition Hierarchy (Ancestors)

Heat Stress DisordersWounds and Injuries

Study Officials

  • Guo LY Professor and Dean of College of Health Sciences, P.hD

    Department of Sports Medicine, Kaohsiung Medical University, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2026

First Posted

April 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations