- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07503977
Acute Physiological Effects of Full-Body Far-Infrared Emitting Textiles on Young Road Cyclists
March 26, 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
Study Type
Interventional
Enrollment (Actual)
9
Phase
- 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
-
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The Marches
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Urbino, The Marches, Italy, 61029
- University of Urbino
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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FIR is a passive emitter composed of textile fibers integrated with bioceramics and light-emitting minerals.
Other Names:
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Placebo Comparator: Control Garment (CG)
A suit that looked identical but lacked the FIR properties was used
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a similar-looking suit but without FIR
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What is the study measuring?
Primary Outcome Measures
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.
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From warm-up to the end of treatment at 1 hour
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Heart Rate
Time Frame: From warm-up to the end of treatment at 1 hour
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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.
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From warm-up to the end of treatment at 1 hour
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Oxygen Consumption
Time Frame: From warm-up to the end of treatment at 1 hour
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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.
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From warm-up to the end of treatment at 1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sprint Peak Power
Time Frame: After the end of treatment at 1 hour
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5-second sprints were performed at the end of the 40-minute steady-state test.
To measure power output, an SRM Ergometer was used, which is capable of measuring and setting a specific power level.
The system is able to maintain a specific power level by adjusting the flywheel resistance and the cyclist's cadence.
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After the end of treatment at 1 hour
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Rate of Perceived Exertion
Time Frame: From warm-up to the end of treatment at 1 hour
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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.
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From warm-up to the end of treatment at 1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
April 15, 2025
Primary Completion (Actual)
June 25, 2025
Study Completion (Actual)
June 25, 2025
Study Registration Dates
First Submitted
March 23, 2026
First Submitted That Met QC Criteria
March 26, 2026
First Posted (Actual)
March 31, 2026
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID 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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