Acute Cardiopulmonary EffectsGALILEOhealthyNCT04162054
Observation of Acute Cardiopulmonary Effects in Healthy Individuals Performing Cardiopulmonary Exercise Test (CPX) During Whole Body Vibration (WBV)
An observational study of Acute Cardiopulmonary Effects, run by Klinikum der Universität Köln at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Cardiopulmonary Effects
- What is being tested?
- Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * healthy individuals planning on performing a WBV-Training * healthy individuals planning on performing a CPX
Who may be able to join
- healthy individuals planning on performing a WBV-Training
- healthy individuals planning on performing a CPX
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Spezialambulanz für pulmonale Hypertonie Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
About this study
Observational study to evaluate acute cardiopulmonary effects of oscillatory whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).
Read the 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).
- Conditions
- Acute Cardiopulmonary Effects
- Being tested
- Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2 in mililiter
maximal Oxygen saturation
Measured: one day
Secondary outcomes (2)
Nadir Co2 at anaerobic threshold
Nadir Co2 in mmHG
Measured: one day
anaerobic threshold (AT)
AT in mililiter
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Mar 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Cardiopulmonary EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universität Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Gerhardt, Klinikum der Universität Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162054
- Sponsor's protocol ID
- 003
- Acronym
- GALILEOhealthy
- Status last verified
- Jan 2020
- First submitted
- 25 Apr 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28100544
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Acute Cardiopulmonary Effects in Healthy Individuals Performing Cardiopulmonary Exercise Test (CPX) During Whole Body Vibration (WBV)
- ClinicalTrials.gov ID
- NCT04162054
- Acronym / sponsor ID
- GALILEOhealthy / 003
- Conditions
- Acute Cardiopulmonary Effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Klinikum der Universität KölnUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to evaluate acute cardiopulmonary effects of oscillatory whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * healthy individuals planning on performing a WBV-Training * healthy individuals planning on performing a CPX
Key inclusion criteria (2 listed)
- healthy individuals planning on performing a WBV-Training
- healthy individuals planning on performing a CPX
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX). | Other | – |
Primary outcome
Peak VO2 in mililiter
Time frame: one day
maximal Oxygen saturation
2 secondary outcomes
Nadir Co2 at anaerobic threshold
Time frame: one day
anaerobic threshold (AT)
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Results publication: PubMed 28100544Gerhardt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiopulmonary Effects, run by Klinikum der Universität Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Gerhardt, MD (+4922147889413, felix.gerhardt@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 in mililiter (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.