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
About this trial
This is an interventional basic science trial for Itch; Athlete focused on measuring whole body vibration, erythema, tryptase, unpleasantness
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
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
NCT ID
NCT03455036
First Posted
February 27, 2018
Last Updated
July 9, 2019
Sponsor
University Hospital, Basel, Switzerland
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
Learn more about this trial
The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
We'll reach out to this number within 24 hrs