AthletesNCT07503977
Acute Physiological Effects of Full-Body Far-Infrared Emitting Textiles on Young Road Cyclists
A study testing FIR in people with Athletes and Cyclists, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- What is being tested?
- FIR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- competitive cyclists with at least two years of racing experience
Who cannot join
- No current or past traumatic or overuse injuries within the 6 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- FIR, Placebo
- Keywords
- Competitive Cycling, Performance, Thermoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIRDevice
Also called Far-Infrared
FIR is a passive emitter composed of textile fibers integrated with bioceramics and light-emitting minerals.
PlaceboDevice
a similar-looking suit but without FIR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FIR |
| Control Garment (CG) | Placebo comparator | A suit that looked identical but lacked the FIR properties was used Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From warm-up to the end of treatment at 1 hour
Secondary outcomes (1)
Rate of Perceived Exertion
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.
Measured: From warm-up to the end of treatment at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start15 Apr 2025
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Giacomo Belmonte, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503977
- Sponsor's protocol ID
- 60_15/03/2023
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07503977
- Acronym / sponsor ID
- 60_15/03/2023
- Keywords
- Competitive Cycling, Performance, Thermoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind crossover study
| Arm | Type | Receives |
|---|---|---|
| Far infrared (FIR) garment | Experimental | Device: FIRFIR 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. |
| Control Garment (CG) | Placebo comparator | Device: PlaceboA suit that looked identical but lacked the FIR properties was used |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- competitive cyclists with at least two years of racing experience
Key exclusion criteria (1 listed)
- No current or past traumatic or overuse injuries within the 6 months prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIRAlso: Far-InfraredFIR is a passive emitter composed of textile fibers integrated with bioceramics and light-emitting minerals. | Device | Far infrared (FIR) garment |
| Placeboa similar-looking suit but without FIR | Device | Control Garment (CG) |
Primary outcome
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.
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.
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.
1 secondary outcome
Rate of Perceived Exertion
Time frame: From warm-up to the end of treatment at 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIR in people with Athletes and Cyclists, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Temperature: Skin and Core (time frame: From warm-up to the end of treatment at 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.