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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
37
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.
Light blue gel where the active ingredient Menthol is replaced by purified water.
Eminence Elite Clinic - Elite Club
Jakarta, DKI Jakarta, Indonesia
Change in Thermal Sensation
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.
Time frame: Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion).
Change in Rating of Perceived Exertion (RPE)
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.
Time frame: Immediately post-run (within 5 minutes after running completion).
Change in Tympanic Temperature
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
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Running Duration
Running duration was calculated as the time the subject took to complete a 5-kilometer run (in minutes) using a digital pocket sports stopwatch
Time frame: Post-run (within 5 minutes after running completion).
Change in Perceived Comfort
To evaluate perceived comfort, participants used a scale that included the options: "comfortable," "somewhat uncomfortable," "uncomfortable," and "extremely uncomfortable
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Hydration Status
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
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Heart Rate
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.
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
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