NCT07503977

Brief Summary

Road cycling is a sport characterized by long, high-intensity training sessions. Cyclists train and compete in varying temperatures, which can affect their performance. Therefore, thermoregulation is a fundamental capacity in endurance sports such as cycling. Far-infrared (FIR) emitting fibers have recently been used in garments during and after exercise to modulate thermoregulation and enhance muscle recovery. Every competitive cyclist voluntarily underwent testing at a temperature-controlled laboratory after reading and signing the informed consent document. Participants were invited to three separate sessions at the laboratory. During the first session, essential personal information (name, surname, sex, age, height and weight) was recorded. In addition, an incremental test was performed on a cycle ergometer to measure VO2Max and ventilatory threshold 1 (VT1). Subsequently, they were randomly divided into two conditions: an experimental garment (EG) with FIR and a control garment (CG). Each test session consisted of 40 minutes at VT1, followed by a 5-second sprint at the end. During the test, various physiological parameters were assessed: Oxygen consumption (VO2), heart rate (HR), blood lactate, body temperature (skin and core temperature), and sensations of exertion and sweating.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 23, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Competitive CyclingPerformanceThermoregulation

Outcome Measures

Primary Outcomes (3)

  • Body Temperature: Skin and Core

    During the constant-power test at VT1 intensity, skin and core temperature were continuously recorded using Calera Research (greenTEG A.G., Rümlang, Switzerland) connected to a personal computer with dedicated software. The system is a heat-flux sensor and research device that eliminates outside environmental influences when monitoring core body temperature, and therefore delivers accurate results independent of the user's physical activity level or external conditions. The device provides access to high-resolution (1Hz) raw data including Core Temperature, Skin Temperature, Accelerometer, and Heat-Flux.

    From warm-up to the end of treatment at 1 hour

  • Heart Rate

    During the constant-power test at VT1 intensity, heart rate (HR) was continuously measured using a Polar H10 chest strap sensor, a device known for its measurement accuracy. The sensor was connected to the cycle ergometer software to analyze heart rate in relation to the cyclist's power output.

    From warm-up to the end of treatment at 1 hour

  • Oxygen Consumption

    During the constant-power test at VT1 intensity, oxygen consumption (VO₂) was measured using a metabolimeter (K5 Cosmed, Italy). Breath-by-breath analysis of exhaled gases was performed.

    From warm-up to the end of treatment at 1 hour

Secondary Outcomes (2)

  • Sprint Peak Power

    After the end of treatment at 1 hour

  • Rate of Perceived Exertion

    From warm-up to the end of treatment at 1 hour

Study Arms (2)

Far infrared (FIR) garment

EXPERIMENTAL

FIR is a passive emitter composed of textile fibers integrated with bioceramics and photoemissive minerals. The fabric utilizes the blackbody principle: it absorbs the infrared spectrum emitted by body heat and reflects it back toward the skin in the form of non-ionizing electromagnetic radiation, with wavelengths that penetrate up to 5 cm into the tissues, inducing resonance in the underlying cellular molecules. These fibers were used to create a suit that participants wore throughout the test.

Device: FIR

Control Garment (CG)

PLACEBO COMPARATOR

A suit that looked identical but lacked the FIR properties was used

Device: Placebo

Interventions

FIRDEVICE

FIR is a passive emitter composed of textile fibers integrated with bioceramics and light-emitting minerals.

Also known as: Far-Infrared
Far infrared (FIR) garment
PlaceboDEVICE

a similar-looking suit but without FIR

Control Garment (CG)

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • competitive cyclists with at least two years of racing experience

You may not qualify if:

  • No current or past traumatic or overuse injuries within the 6 months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Urbino

Urbino, The Marches, 61029, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The participants dressed in a suit with FIR (Far-Infrared) properties that looked identical to the placebo suit. The evaluators also did not know which suit was the experimental one and which was the control suit.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double-blind crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 31, 2026

Study Start

April 15, 2025

Primary Completion

June 25, 2025

Study Completion

June 25, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations