Observation of Acute Cardiopulmonary Effects in Healthy Individuals Performing Cardiopulmonary Exercise Test (CPX) During Whole Body Vibration (WBV) (GALILEOhealthy)

January 20, 2020 updated by: Felix Gerhardt, Klinikum der Universität Köln
Observational study to evaluate acute cardiopulmonary effects of oscillatory whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Oscillatory whole-body vibration (WBV) is a novel exercise modality, which is performed on a vibrating platform that moves in sinusoidal oscillations, and during which static and dynamic exercises can be performed. Rapid movements of the platform lead to muscle spindle reflexes, which result in reflectory contraction of muscle groups and thus promote gain of muscle strength and power. The most efficient vibration rate enhancing muscle function is assumed to be ∼20 Hz, leading to constant muscle contraction and anaerobic metabolism of the affected muscle fibres. As a consequence, lactate liberation serves as a stimulus for muscle gain.This methodology has been successfully utilised to enhance moving velocity, muscle power and strength in young athletes and chronic obstructive pulmonary disease though not been understood in all details. Therefore this investigation will help to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Köln, NRW, Germany, 50937
        • Spezialambulanz für pulmonale Hypertonie Uniklinik Köln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • exclusion to perform CPX
  • exclusion to perform WBV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak VO2 in mililiter
Time Frame: one day
maximal Oxygen saturation
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nadir Co2 at anaerobic threshold
Time Frame: one day
Nadir Co2 in mmHG
one day
anaerobic threshold (AT)
Time Frame: one day
AT in mililiter
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum der Universität Köln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (ACTUAL)

November 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 20, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 003 (033)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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