跳至主要内容
临床试验/NCT05086640
NCT05086640Unknown不适用

Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners

Institut de Formation et de Recherche en Médecine de Montagne1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年7月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
82
试验地点
1
主要终点
Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.

研究概览

简要总结

For more than a decade, worldwide participation in ultra-marathons and ultra-trails (running races longer than the 42.195 km marathon) has been increasing. Although considered benign, blisters are a common problem, with serious consequences and limiting performance.

Although blisters are a major factor limiting endurance performance, they are a reason for only 5.8% of ultra-trail runners to quit.

While equipment is improving and participants are increasing and intensifying their training, there is no consensus on the prevention of blisters in ultra-trail running, even though it is the number one factor limiting sports performance. There are few prospective interventional studies on the prevention of blisters during outdoor activities.

On many running forums, there is the hypothesis that lemon applied to the feet prevents the appearance of blisters. This hypothesis has never been scientifically studied.

The investigators hypothesize that the local application of Lemon allows a reduction in the number of blisters on ultra-trail.

The objective of this Blisters-stop 2 study is to evaluate the efficacy of local application of Lemon in preventing the appearance of blisters.

详细描述

The patients included will be runners registered in a trail of a distance greater than 40km for whom Lemon will be applied on the friction zones of one foot as a preventive measure (28 days).

The study is coordinated by IFREMMONT and the Pays du Mont Blanc Hospitals and 82 patients must be included in order to obtain statistical significance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ultra-trail participants with validated registration
  • Major (≥ 18 years old)

排除标准

  • Presence of blisters or other skin lesions on the feet 28 days before the race
  • Amputation of one or two feet
  • Allergy to lemon
  • Psychiatric disorders making comprehension impossible
  • Lack of social security coverage

结局指标

主要结局

Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.

时间窗: up to 1 week

Blisters on each feet or non

次要结局

  • Severity of residual blisters(up to 1 week)
  • Main locations of residual blisters(up to 1 week)
  • Feasibility of the protocole(up to 1 week)
  • Tolerance(up to 1 week)
  • Compliance(up to 1 week)

研究者

发起方
Institut de Formation et de Recherche en Médecine de Montagne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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