Acute Physiological Effects of Full-Body Far-Infrared Emitting Textiles on Young Road Cyclists

August 13, 2026 updated by: Giacomo Belmonte, University of Palermo

Acute Physiological Effects of Full-Body Far-Infrared Emitting Textiles on Body Temperature, Heart Rate, Power Output, Oxygen Consumption, Hydration, Perceived Comfort, and Hematological Parameters in Young Road Cyclists

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
10

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

  • Italy
    • The Marches
      • Urbino, The Marches, Italy, 61029
        • University of Urbino

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • competitive cyclists with at least two years of racing experience

Exclusion Criteria:

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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: Far infrared (FIR) garment
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
FIR is a passive emitter composed of textile fibers integrated with bioceramics and light-emitting minerals.
Other Names:
  • Far-Infrared
Placebo Comparator: Control Garment (CG)
A suit that looked identical but lacked the FIR properties was used
Device: Placebo
a similar-looking suit but without FIR

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
Measure Description
Time Frame
Body Temperature: Skin and Core
Time Frame: From warm-up to the end of treatment at 1 hour
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
Time Frame: From warm-up to the end of treatment at 1 hour
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
Time Frame: From warm-up to the end of treatment at 1 hour
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Perceived Exertion
Time Frame: From warm-up to the end of treatment at 1 hour
The modified Borg 6-20 scale for assessing perceived exertion (RPE) was used during the 40-minute constant-load exercise test at VT1. Measurements were taken continuously at 5-minute intervals throughout the test.
From warm-up to the end of treatment at 1 hour

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.
University of Palermo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Urbino "Carlo Bo"

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.
April 15, 2025

Primary Completion (Actual)

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.
June 25, 2025

Study Completion (Actual)

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.
June 25, 2025

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).
March 23, 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.
March 26, 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.
March 31, 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.
August 17, 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.
August 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.
August 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 60_15/03/2023

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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