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临床试验/NCT03455036
NCT03455036已完成不适用

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

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Itch intensity

研究概览

简要总结

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:

  1. To determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
  2. To determine the effect of WBV on immunoglobulin E (IgE) and serum tryptase

详细描述

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:

  1. to determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
  2. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18-35 years
  • Informed Consent as documented by signature (Appendix Informed Consent Form)

排除标准

  • itchy skin diseases
  • hay fever
  • chronic venous insufficiency
  • peripheral artery disease
  • musculoskeletal diseases or injuries affecting the legs, hips and pelvis
  • BMI < 17 and > 35 kg/m2
  • pregnancy

研究组 & 干预措施

Whole body vibration training

Experimental

Healthy female subjects complete whole body vibration training (10 x 1 min exposure)

干预措施: Whole body vibration training (Other)

结局指标

主要结局

Itch intensity

时间窗: 0 months

0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10)

次要结局

  • Itch characteristics(0 months)
  • Skin surface temperature(0 months)
  • Itch unpleasantness(0 months)
  • Erlanger atopy score(0 months)
  • Erythema intensity(0 months)
  • Total immunoglobulin E (IgE) concentration(0 months)
  • Tryptase concentration(0 months)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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