Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03455036
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2018-02-27
Brief Title:
The Mysterious onOff Itch and Erythema During Whole Body Vibration Exercise
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
The Mysterious onOff Itch and Erythema During Whole Body Vibration Exercise
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIBRA
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 andor 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
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
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 andor 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None