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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Blister of Foot, Sport Injury

Intervention / Treatment
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* Other: Lemon foot to prevent blister


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultra-trail participants with validated registration Major (≥ 18 years old) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lemon foot<br>Application of Lemon in the Prevention of Blisters on one feet | Other: Lemon foot to prevent blister<br>* The investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail.<br>|
| No Intervention: Control foot without lemon<br>No application of Lemon or any other prevention cream in the Prevention of Blisters on one feet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or not of blisters at the end of the ultra-trail or at the time of abandonment. | Blisters on each feet or non | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the protocole | Easy to follow for runners, lemon used every day, how mutch misses | up to 1 week | 
| Compliance | Compliance to the protocole | up to 1 week | 
| Tolerance | Tolerance to the protocole | up to 1 week | 
| Main locations of residual blisters | Where on each feet | up to 1 week | 
| Severity of residual blisters | Severity | up to 1 week |