NCT04162054

Brief Summary

Observational study to evaluate acute cardiopulmonary effects of oscillatory whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 25, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

April 25, 2019

Last Update Submit

January 20, 2020

Conditions

Acute Cardiopulmonary Effects

Outcome Measures

Primary Outcomes (1)

  • Peak VO2 in mililiter

    maximal Oxygen saturation

    one day

Secondary Outcomes (2)

  • Nadir Co2 at anaerobic threshold

    one day

  • anaerobic threshold (AT)

    one day

Interventions

Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).OTHER

Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* healthy individuals planning on performing a WBV-Training * healthy individuals planning on performing a CPX

You may qualify if:

  • healthy individuals planning on performing a WBV-Training
  • healthy individuals planning on performing a CPX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spezialambulanz für pulmonale Hypertonie Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

  • Gerhardt F, Dumitrescu D, Gartner C, Beccard R, Viethen T, Kramer T, Baldus S, Hellmich M, Schonau E, Rosenkranz S. Oscillatory whole-body vibration improves exercise capacity and physical performance in pulmonary arterial hypertension: a randomised clinical study. Heart. 2017 Apr;103(8):592-598. doi: 10.1136/heartjnl-2016-309852. Epub 2017 Jan 18.

    PMID: 28100544RESULT

Central Study Contacts

Felix Gerhardt, MD

CONTACT

+4922147889413felix.gerhardt@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

April 25, 2019

First Posted

November 14, 2019

Study Start

March 1, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

DE(1)