Athletic Performance, Heat Stress
Conditions
Keywords
menthol, topical gel, mid-cooling, thermoregulation, heat stress, thermal sensation, exercise, running, athletic performance
Brief summary
The goal of this clinical trial is to evaluate the effectiveness of topical menthol as a cooling method during exercise in a hot air environment in healthy adult recreational runners aged 18 to 45 years. The main questions it aims to answer are: What is the difference in thermal sensation between the topical menthol gel application and a placebo during exercise? How does the application of topical menthol affect body temperature, heart rate, and physical performance compared to a placebo? Researchers will compare a 4% Menthol gel to a placebo gel in a cross-over design to see if the menthol gel improves thermal sensation, regulates body temperature, and enhances physical performance and comfort. Participants will: 1. Undergo a screening process including a medical history review, physical examination, resting ECG, blood sugar test, and a Bleep fitness test. 2. Participate in two separate running activities at an athletic field, separated by a wash-out period of 7 days + 1 day.Have the assigned gel (menthol or placebo) applied to their neck, front upper arms, and front upper legs while running (specifically between kilometers 2.5 and 2.8). 3. Complete pre-run and post-run assessments measuring weight, skin and tympanic temperature, heart rate, vertical jump height, running duration, perceived exertion (RPE), thermal sensation, and comfort.
Interventions
DRUGLight blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.
The test drug, i.e. 4% Menthol gel or placebo, will be applied by rubbing on the neck area, the front side of the upper arm and the front side of the upper leg. The neck area was chosen because there is a carotid artery in the neck area, which is said to have an impact on changes in body temperature in the hypothalamus. In addition, the upper arm and upper leg areas were chosen because they are the extremity areas closest to the core of the body and perform a lot of movement while running. Some journals concluded that the application of cooling methods in the hand and thigh area is effective for cooling methods.
OTHERPlacebo
Light blue gel where the active ingredient Menthol is replaced by purified water.
Sponsors
Taisho Pharmaceutical Indonesia
Trisakti University
Atma Jaya Catholic University of Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults, 18 - 45 years old * Have a personal best 10-kilometer run time of under one hour (which will be confirmed during the screening of prospective Subjects through history taking) in the last 6 months. * Doing running training at least 3 times/week for the past 1 year * Have a level of heart-lung endurance or VO2max that is at least included in the average criteria (known through examination: Bleep test) * Meets Subject screening criteria by answering "No" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) questionnaire. * Have normal resting ECG and normal GDS results on screening of prospective Subjects. * At the time of the study, the body temperature was within the normal range
Exclusion criteria
* Pregnant and/or breastfeeding women * Have had a musculoskeletal injury in the last three months and still have symptoms or complaints * Are experiencing acute infectious disorders, such as gastrointestinal, respiratory infections * During treatment for chronic diseases (e.g. high blood pressure or hypertension, diabetes or diabetes mellitus, heart disease) * Have a history of hypersensitivity or allergy to menthol or skin-applied products (especially gel-based products) * Has a history of cold allergy * Have a positive COVID-19 test result at the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Thermal Sensation | Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion). | Assessed using a 7-point thermal sensation scale. The scale ranges from -3 to +3, where -3 represents "cold", 0 represents "neutral", and +3 represents "hot". A higher score indicates a greater sensation of heat. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rating of Perceived Exertion (RPE) | Immediately post-run (within 5 minutes after running completion). | Assessed using the Borg Rating of Perceived Exertion (RPE) scale. The scale ranges from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion". Higher scores represent a greater perceived physical effort by the participant. |
| Change in Tympanic Temperature | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). | Measured in degrees Celsius (°C) using a tympanic thermometer to evaluate thermoregulation and core body temperature changes in response to the running exercise and cooling intervention |
| Running Duration | Post-run (within 5 minutes after running completion). | Running duration was calculated as the time the subject took to complete a 5-kilometer run (in minutes) using a digital pocket sports stopwatch |
| Change in Perceived Comfort | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). | To evaluate perceived comfort, participants used a scale that included the options: "comfortable," "somewhat uncomfortable," "uncomfortable," and "extremely uncomfortable |
| Change in Hydration Status | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). | Hydration status, categorized as "well-hydrated," "mildly dehydrated," or "dehydrated,". Pre run hydration status was assessed by matching urine color to a color chart. Post run hydration status was assessed through percentage body weight (BW) loss |
| Change in Heart Rate | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). | Measured in beats per minute (bpm) was measured using a Polar Heart Rate Monitor to evaluate cardiovascular strain and physical intensity during the running exercise. This will include assessing the mean heart rate and the highest heart rate frequency. |
Countries
Indonesia
Outcome results
None listed