Exercise Induced Muscle DamageNCT04273789
Effect of Far Infrared Reflecting Sleepwear on Recovery and Sleep
A study testing Far infrared reflecting sleepwear in people with Exercise Induced Muscle Damage, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Far infrared light (FIR, 5.6-1000 µm) penetrates our skin and reaches the underlying tissue up to 4 cm and promotes widening of the blood vessels (vasodilation). This results in increased blood flow in the tissue under the skin, without heating up the skin itself. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Muscle Damage
- What is being tested?
- Far infrared reflecting sleepwear
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Feb 2020to 2 Jul 2020
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physically active (>3h of sports per week)
- BMI < 25
Who cannot join
- Sleep problems (assessed using standardized questionnaire included in entrance questionnaire)
- Cardiovascular problems (self-reported in entrance questionnaire)
- Sensitive skin/allergies that present on a skin level (self-reported in entrance questionnaire)
- Knee pain while exercising (self-reported in entrance questionnaire)
- Night shift work during study period
Trial locations and contacts
1 site in 1 country.
About this study
Far infrared light (FIR, 5.6-1000 µm) penetrates our skin and reaches the underlying tissue up to 4 cm and promotes widening of the blood vessels (vasodilation). This results in increased blood flow in the tissue under the skin, without heating up the skin itself. Increased blood flow allows more oxygen to reach the muscles and more metabolic waste products to be transported away from the muscles. Studies assessing clothing containing an FDA approved ceramic particles covered yarn that reflect FIR light showed delayed onset muscle pain decreased and a reduction in inflammatory markers in professional athletes.
The aim of this study is to investigate the effect of far infrared reflecting sleepwear on night-time recovery and Sleep in a broader population, namely physically active adults (non-professional).
Read the detailed description
Far infrared light (FIR, 5.6-1000 µm) penetrates our skin and reaches the underlying tissue up to 4 cm and promotes widening of the blood vessels (vasodilation). This results in increased blood flow in the tissue under the skin, without heating up the skin itself. Increased blood flow allows more oxygen to reach the muscles and more metabolic waste products to be transported away from the muscles. Thus, exposure to FIR might aid the process of recovery in muscle groups lying close to the skin.
Indeed several research groups could show that exposure to FIR aids recovery. 30 min intense far infrared exposure enhanced recovery from exercise-induced muscle damage in highly trained runners. Studies assessing clothing containing an FDA approved ceramic particles covered yarn that reflect FIR light showed delayed onset muscle pain decreased and a reduction in inflammatory markers.
Since a large part of our recovery takes place during sleep it is of interest to assess the effect of FIR on night-time recovery and sleep itself. One study showed that FIR exposure during sleep increased the amount of non-rem sleep in rats. This effect has not been replicated in humans, possibly because increased temperature is not beneficial for sleep and thus should be kept constant. The aim of this study is to investigate the effect of far infrared reflecting sleepwear on night-time recovery and sleep.
Sleepwear of a breathing and thermoregulating material, with a layer of FIR reflecting minerals printed on the outer surface, will be assessed. Physically active males are invited to participate in two bouts of exercise in the lab, separated by one week. The exercise bout targets one leg, the second week the other leg is exercised. Starting the protocol with the dominant/non-dominant leg (determined in first session) will be randomized. Participants will then wear the FIR reflecting sleepwear and placebo sleepwear respectively at home for the 7 nights following each bout of exercise.
To assess sleep quality activity will be measured using wrist worn activity trackers. To assess recovery physical performance will be measured (max. single leg force and jump height), knee range of motion and thigh circumference of each leg at before each exercise bout, after each exercise bout and at three days after each exercise bout. Per exercise bout muscle soreness will be induced in one leg of the two legs respectively, to account for a repeated bout effect.
It is hypothesized that more overnight recovery takes place during nights with FIR reflecting sleepwear compared to nights with placebo sleepwear.
- Conditions
- Exercise Induced Muscle Damage
- Being tested
- Far infrared reflecting sleepwear, Placebo sleepwear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far infrared reflecting sleepwearDevice
100% microlyocell sleepwear (shorts + shirt) with a ceramic print that reflects far infrared light (FIR, 5.6-1000 µm) emitted by the human body. Since FIR active garments are not powered, but reflect recycle light energy emitted by the body of the wearer, they have irradiances between 0.1-5 mW/cm^2.
Placebo sleepwearDevice
100% microlyocell sleepwear (shorts + shirt)
| Study group | Role | What they receive |
|---|---|---|
| far infrared reflecting sleepwear | Experimental | Sleepwear (shorts + tshirt) with far infrared reflecting ceramic print produced by Dagsmejan AG (Zurich, Switzerland) Receives: Device: Far infrared reflecting sleepwear |
| Placebo sleepwear | Placebo comparator | Sleepwear (shorts + tshirt) Receives: Device: Placebo sleepwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time of flight during jump (s)
Time of flight during jump is the time between offset and landing. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Measured: 72 hours post exercise bout in week 1 and week 2
Change in maximum isometic leg force (N)
Maximum isometic leg force will be measured while participants are lying on their back with knees 90 Degrees bend. They press against a vertically mounted force plate. The average of 3 measurements separated by 1 minute break is used.The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Measured: 72 hours post exercise bout in week 1 and week 2
Change in leg circumference (m)
Circumference of the tight while standing will be measured using a measurement tape. The average of 3 measurements separated by 1 minute break is used. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Measured: 72 hours post exercise bout in week 1 and week 2
Change in knee range of motion (Degrees)
Active range of motion of the knee while lying on the stomach is determined using a goniometer. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Measured: 72 hours post exercise bout in week 1 and week 2
Change in muscle soreness (rating on visual analog scale)
Subjectively experienced delayed onset muscle soreness measured using a visual analog scale. The change in soreness over time is of interest, as well as the influence of the intervention. The influence of the intervention is determined by comparing the values 1, 2, 3, 4, 5, 6 and 7 post exercise bout of both weeks.
Measured: 1, 2, 3, 4, 5, 6 days post exercise bout in week 1 and week 2
Secondary outcomes (1)
Activity during night
Activity during night is measured using a wristworn actigraphy tracker. Based on this data sleep onset latency, sleep eficiency, sleep duration, number and duration of awakenings are calculated using validated algorithms. The influence of the intervention is determined by comparing the values 1, 2, 3, 4, 5, 6 and 7 post exercise bout of both weeks.
Measured: 1, 2, 3, 4, 5, 6 days post exercise bout in week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start17 Feb 2020
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced Muscle DamageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Riener, Prof. Dr., Principal investigator, Swiss FIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273789
- Sponsor's protocol ID
- FIRsleepwear
- Status last verified
- Jul 2020
- First submitted
- 12 Feb 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We consider uploading the actigraphy measurements to the ETH Research Collection database to make them available to other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Far Infrared Reflecting Sleepwear on Recovery and Sleep
- ClinicalTrials.gov ID
- NCT04273789
- Acronym / sponsor ID
- FIRsleepwear
- Conditions
- Exercise Induced Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 18 Feb 2020 (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.
Far infrared light (FIR, 5.6-1000 µm) penetrates our skin and reaches the underlying tissue up to 4 cm and promotes widening of the blood vessels (vasodilation). This results in increased blood flow in the tissue under the skin, without heating up the skin itself. Increased blood flow allows more oxygen to reach the muscles and more metabolic waste products to be transported away from the muscles. Studies assessing clothing containing an FDA approved ceramic particles covered yarn that reflect FIR light showed delayed onset muscle pain decreased and a reduction in inflammatory markers in professional athletes.
The aim of this study is to investigate the effect of far infrared reflecting sleepwear on night-time recovery and Sleep in a broader population, namely physically active adults (non-professional).
Detailed description
Far infrared light (FIR, 5.6-1000 µm) penetrates our skin and reaches the underlying tissue up to 4 cm and promotes widening of the blood vessels (vasodilation). This results in increased blood flow in the tissue under the skin, without heating up the skin itself. Increased blood flow allows more oxygen to reach the muscles and more metabolic waste products to be transported away from the muscles. Thus, exposure to FIR might aid the process of recovery in muscle groups lying close to the skin.
Indeed several research groups could show that exposure to FIR aids recovery. 30 min intense far infrared exposure enhanced recovery from exercise-induced muscle damage in highly trained runners. Studies assessing clothing containing an FDA approved ceramic particles covered yarn that reflect FIR light showed delayed onset muscle pain decreased and a reduction in inflammatory markers.
Since a large part of our recovery takes place during sleep it is of interest to assess the effect of FIR on night-time recovery and sleep itself. One study showed that FIR exposure during sleep increased the amount of non-rem sleep in rats. This effect has not been replicated in humans, possibly because increased temperature is not beneficial for sleep and thus should be kept constant. The aim of this study is to investigate the effect of far infrared reflecting sleepwear on night-time recovery and sleep.
Sleepwear of a breathing and thermoregulating material, with a layer of FIR reflecting minerals printed on the outer surface, will be assessed. Physically active males are invited to participate in two bouts of exercise in the lab, separated by one week. The exercise bout targets one leg, the second week the other leg is exercised. Starting the protocol with the dominant/non-dominant leg (determined in first session) will be randomized. Participants will then wear the FIR reflecting sleepwear and placebo sleepwear respectively at home for the 7 nights following each bout of exercise.
To assess sleep quality activity will be measured using wrist worn activity trackers. To assess recovery physical performance will be measured (max. single leg force and jump height), knee range of motion and thigh circumference of each leg at before each exercise bout, after each exercise bout and at three days after each exercise bout. Per exercise bout muscle soreness will be induced in one leg of the two legs respectively, to account for a repeated bout effect.
It is hypothesized that more overnight recovery takes place during nights with FIR reflecting sleepwear compared to nights with placebo sleepwear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| far infrared reflecting sleepwear | Experimental | Device: Far infrared reflecting sleepwearSleepwear (shorts + tshirt) with far infrared reflecting ceramic print produced by Dagsmejan AG (Zurich, Switzerland) |
| Placebo sleepwear | Placebo comparator | Device: Placebo sleepwearSleepwear (shorts + tshirt) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physically active (>3h of sports per week)
- BMI < 25
Key exclusion criteria (5 listed)
- Sleep problems (assessed using standardized questionnaire included in entrance questionnaire)
- Cardiovascular problems (self-reported in entrance questionnaire)
- Sensitive skin/allergies that present on a skin level (self-reported in entrance questionnaire)
- Knee pain while exercising (self-reported in entrance questionnaire)
- Night shift work during study period
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 |
|---|---|---|
| Far infrared reflecting sleepwear100% microlyocell sleepwear (shorts + shirt) with a ceramic print that reflects far infrared light (FIR, 5.6-1000 µm) emitted by the human body. Since FIR active garments are not powered, but reflect recycle light energy emitted by the body of the wearer, they have irradiances between 0.1-5 mW/cm^2. | Device | far infrared reflecting sleepwear |
| Placebo sleepwear100% microlyocell sleepwear (shorts + shirt) | Device | Placebo sleepwear |
Primary outcome
Change in time of flight during jump (s)
Time frame: 72 hours post exercise bout in week 1 and week 2
Time of flight during jump is the time between offset and landing. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Change in maximum isometic leg force (N)
Time frame: 72 hours post exercise bout in week 1 and week 2
Maximum isometic leg force will be measured while participants are lying on their back with knees 90 Degrees bend. They press against a vertically mounted force plate. The average of 3 measurements separated by 1 minute break is used.The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Change in leg circumference (m)
Time frame: 72 hours post exercise bout in week 1 and week 2
Circumference of the tight while standing will be measured using a measurement tape. The average of 3 measurements separated by 1 minute break is used. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Change in knee range of motion (Degrees)
Time frame: 72 hours post exercise bout in week 1 and week 2
Active range of motion of the knee while lying on the stomach is determined using a goniometer. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.
Change in muscle soreness (rating on visual analog scale)
Time frame: 1, 2, 3, 4, 5, 6 days post exercise bout in week 1 and week 2
Subjectively experienced delayed onset muscle soreness measured using a visual analog scale. The change in soreness over time is of interest, as well as the influence of the intervention. The influence of the intervention is determined by comparing the values 1, 2, 3, 4, 5, 6 and 7 post exercise bout of both weeks.
1 secondary outcome
Activity during night
Time frame: 1, 2, 3, 4, 5, 6 days post exercise bout in week 1 and week 2
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 3 Aug 2020.
- Individual participant dataSharing planned: Yes. We consider uploading the actigraphy measurements to the ETH Research Collection database to make them available to other investigators.
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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.
Robert Riener, Prof. Dr. principal investigator
Swiss FIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Far infrared reflecting sleepwear in people with Exercise Induced Muscle Damage, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 2 inclusion and 5 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 3 Aug 2020. 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 Switzerland. 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?
Change in time of flight during jump (s) (time frame: 72 hours post exercise bout in week 1 and week 2). The study lists 5 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 3 Aug 2020.