NCT03455036

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

February 27, 2018

Last Update Submit

July 9, 2019

Conditions

Itch; Athlete

Keywords

whole body vibration, erythema, tryptase, unpleasantness

Outcome Measures

Primary Outcomes (1)

  • Itch intensity

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

    0 months

Secondary Outcomes (7)

  • Erlanger atopy score

    0 months

  • Itch characteristics

    0 months

  • Itch unpleasantness

    0 months

  • Skin surface temperature

    0 months

  • Erythema intensity

    0 months

  • +2 more secondary outcomes

Study Arms (1)

Whole body vibration training

EXPERIMENTAL

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

Other: Whole body vibration training

Interventions

Whole body vibration trainingOTHER

10 x 1 min whole body vibration exposure

Whole body vibration training

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale participants only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

PruritusErythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Annegret Muendermann, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The design of the study is a single-centre cross-sectional single-arm intervention study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 6, 2018

Study Start

December 18, 2017

Primary Completion

January 31, 2018

Study Completion

June 17, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)