Effectiveness of Topical Menthol as A Cooling Method During Exercise in A Recreational Runner Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Thermal Sensation
研究概览
简要总结
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:
- Undergo a screening process including a medical history review, physical examination, resting ECG, blood sugar test, and a Bleep fitness test.
- 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).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo Group
Placebo: light blue gel where the active ingredient Menthol is replaced by purified water.
干预措施: Placebo (Other)
Menthol Group
Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.
干预措施: Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%. (Drug)
结局指标
主要结局
Change in Thermal Sensation
时间窗: 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.
次要结局
- Change in Rating of Perceived Exertion (RPE)(Immediately post-run (within 5 minutes after running completion).)
- Change in Tympanic Temperature(Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).)
- Running Duration(Post-run (within 5 minutes after running completion).)
- Change in Perceived Comfort(Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).)
- Change in Hydration Status(Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).)
- Change in Heart Rate(Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).)
研究者
A. Andi Kurniawan
dr. Sp.KO., Subsp.ALK(K)
Taisho Pharmaceutical Indonesia