- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455036
The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise (VIBRA)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basel Stadt
-
Basel, Basel Stadt, Switzerland, 4031
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole body vibration training
Healthy female subjects complete whole body vibration training (10 x 1 min exposure)
|
10 x 1 min whole body vibration exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Itch intensity
Time Frame: 0 months
|
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
Time Frame: 0 months
|
Erlanger atopy score (best score: 0 - no atopy; worst score: 100)
|
0 months
|
Itch characteristics
Time Frame: 0 months
|
measured using Eppendorf itch questionnaire
|
0 months
|
Itch unpleasantness
Time Frame: 0 months
|
0 to 10 numerical rating scale (NRS) (best score: 0 - no unpleasantness; worst score: 10)
|
0 months
|
Skin surface temperature
Time Frame: 0 months
|
assessed using a infrared thermal camera
|
0 months
|
Erythema intensity
Time Frame: 0 months
|
assessed using an erythema meter
|
0 months
|
Total immunoglobulin E (IgE) concentration
Time Frame: 0 months
|
Serum
|
0 months
|
Tryptase concentration
Time Frame: 0 months
|
serum
|
0 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Annegret Muendermann, PhD, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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