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

Primary Purpose

Itch; Athlete

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Whole body vibration training
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Itch; Athlete focused on measuring whole body vibration, erythema, tryptase, unpleasantness

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole body vibration training

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2018
Last Updated
July 9, 2019
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03455036
Brief Title
The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
Acronym
VIBRA
Official Title
The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itch; Athlete
Keywords
whole body vibration, erythema, tryptase, unpleasantness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The design of the study is a single-centre cross-sectional single-arm intervention study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration training
Arm Type
Experimental
Arm Description
Healthy female subjects complete whole body vibration training (10 x 1 min exposure)
Intervention Type
Other
Intervention Name(s)
Whole body vibration training
Intervention Description
10 x 1 min whole body vibration exposure
Primary Outcome Measure Information:
Title
Itch intensity
Description
0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10)
Time Frame
0 months
Secondary Outcome Measure Information:
Title
Erlanger atopy score
Description
Erlanger atopy score (best score: 0 - no atopy; worst score: 100)
Time Frame
0 months
Title
Itch characteristics
Description
measured using Eppendorf itch questionnaire
Time Frame
0 months
Title
Itch unpleasantness
Description
0 to 10 numerical rating scale (NRS) (best score: 0 - no unpleasantness; worst score: 10)
Time Frame
0 months
Title
Skin surface temperature
Description
assessed using a infrared thermal camera
Time Frame
0 months
Title
Erythema intensity
Description
assessed using an erythema meter
Time Frame
0 months
Title
Total immunoglobulin E (IgE) concentration
Description
Serum
Time Frame
0 months
Title
Tryptase concentration
Description
serum
Time Frame
0 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female participants only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annegret Muendermann, PhD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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