The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise

Study Overview
=================
Brief Summary
-----------------
Intense itch on the legs sometimes associated with redness can be adverse effects of whole body vibration (WBV) according to own observations and numerous posts in non-professional online-blogs. To the investigators' knowledge, the appearance of itch and/or a rash during WBV exercise has not yet been described. The research objectives are: To determine the effect of WBV on itch rating and its unpleasantness and on skin changes. To determine the effect of WBV on immunoglobulin E (IgE) and serum tryptase

Detailed Description
-----------------
Objectives Intense itch on the legs sometimes associated with redness can be adverse effects of WBV according to the investigators observations and numerous posts in non-professional online-blogs. To the investigators knowledge, the appearance of itch and/or a rash during WBV exercise has not yet been described. The objectives of this study are: to determine the effect of WBV on itch rating and its unpleasantness and on skin changes. to determine the effect of WBV on serum tryptase. Hypothesis The working hypothesis is that repeated WBV leads to an increase of itching and erythema. Further investigators hypothesize that repeated WBV does not lead to an increase in serum tryptase. Inclusion and exclusion criteria will be evaluated. Subjects will be instructed to not shave their legs one week before the intervention day and to shave only the left leg from the ankle to the knee on the day prior to the intervention day. On the intervention day, subjects will be informed in detail about the study protocol and written informed consent will be collected. If a pregnancy cannot be excluded (days from last menstruation) subjects are instructed to do a pregnancy test. Then, a blood sample will be taken. Subsequently, subjects will be instructed to stand on the vibration plate (Galileo 900) in a slightly crouched position with their hands loosely resting on the rail. Subjects will complete ten 1-minute WBV repetitions interspaced by 1-minute breaks in seated position. During each break, subjects will rate the itch intensity, and skin changes will be captured. Sixty minutes after the last WBV repetition, another blood sample will be taken. Subjects will rest until itch and erythema return to baseline. During resting phase subjects will fill in the Eppendorf itch questionnaire and the Erlanger atopy score.

Official Title
-----------------
The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise

Conditions
-----------------
Itch; Athlete

Intervention / Treatment
-----------------
* Other: Whole body vibration training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-35 years female Informed Consent as documented by signature (Appendix Informed Consent Form) Exclusion Criteria: itchy skin diseases hay fever asthma chronic venous insufficiency peripheral artery disease musculoskeletal diseases or injuries affecting the legs, hips and pelvis BMI < 17 and > 35 kg/m2 pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: The design of the study is a single-centre cross-sectional single-arm intervention study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole body vibration training<br>Healthy female subjects complete whole body vibration training (10 x 1 min exposure) | Other: Whole body vibration training<br>* 10 x 1 min whole body vibration exposure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Itch intensity | 0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10) | 0 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erlanger atopy score | Erlanger atopy score (best score: 0 - no atopy; worst score: 100) | 0 months | 
| Itch characteristics | measured using Eppendorf itch questionnaire | 0 months | 
| Itch unpleasantness | 0 to 10 numerical rating scale (NRS) (best score: 0 - no unpleasantness; worst score: 10) | 0 months | 
| Skin surface temperature | assessed using a infrared thermal camera | 0 months | 
| Erythema intensity | assessed using an erythema meter | 0 months | 
| Total immunoglobulin E (IgE) concentration | Serum | 0 months | 
| Tryptase concentration | serum | 0 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
whole body vibration, erythema, tryptase, unpleasantness