Pulmonary Artery HypertensionGALILEO-PAHNCT01763112
Training With Whole Body Vibration Device in Patients With PAH
A study testing Exercise Group Galileo PAH in people with Pulmonary Artery Hypertension, run by Klinikum der Universität Köln at 1 site in Germany.
Trial summary
Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- Exercise Group Galileo PAH
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18-90 years
- Signed informed consent
- Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
- Invasively confirmed PAH
- 6MWT ≥ 50 m
- Stable specific therapy for at least 2 months
Show all 9Show fewer
- Ability to perform bike test
- Ability to perform wbv training
- NYHA/WHO-FC II-III
Who cannot join
- any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma
- Rehabilitation or other training concept performed within 2 months before inclusion
- pregnancy
- acute thrombosis
- newly implanted Hip or Knee
- recent bone fracture
- Disability to confirm consent
- NYHA/WHO-FC IV
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
Official title: Influence of Training With Whole Body Vibration Device (Galileo) on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH). (GALILEO PAH)
Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.
Read the detailed description
Study Design: Open Monocentric prospective randomized observational trial Study arms: Treatment group (4-weeks wbv training) planned 20 patients Control group: planned 20 patients Endpoint (-s): Changes in muscle power, changes in 6-Minute Walk Distance (6MWD), changes in QoL changes in peak VO2 (bike exercise test)
Major study procedures:
Blood samples, vital parameters, questionnaires, echocardiography, lung function test, blood gas analysis, bike exercise test, 6-Minute Walk test, ECG, Chair rising test, power plate measurement, walk across test
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- Exercise Group Galileo PAH
- Keywords
- Influence of training with whole body vibration device
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Group Galileo PAHDevice
The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | This group will not do any specific training baseline and week 4 investigation will be done only |
| Exercise Group Galileo PAH | Active comparator | The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks Receives: Device: Exercise Group Galileo PAH |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in 6-Minute Walk Distance (6MWD)
Measured: baseline and week 4
Secondary outcomes (3)
Changes in Quality of life
Measured: baseline and week 4
Changes in peak Vo2
Measured: baseline and week 4
Changes in muscle power
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (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 Pulmonary Artery HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- Investigators
- Felix Gerhardt, PhD, Principal investigator, Klinik III für Innere Medizin Uniklinik KölnStephan Rosenkranz, PhD, Principal investigator, Klinik III für Innere Medizin der Uniklinik Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763112
- Sponsor's protocol ID
- 001
- Acronym
- GALILEO-PAH
- Status last verified
- Mar 2015
- First submitted
- 4 Jan 2013
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Training With Whole Body Vibration Device (Galileo) on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH). (GALILEO PAH)
- ClinicalTrials.gov ID
- NCT01763112
- Acronym / sponsor ID
- GALILEO-PAH / 001
- Conditions
- Pulmonary Artery Hypertension
- Keywords
- Influence of training with whole body vibration device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Klinikum der Universität KölnUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 Jan 2013 (estimated)
- 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.
Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.
Detailed description
Study Design: Open Monocentric prospective randomized observational trial Study arms: Treatment group (4-weeks wbv training) planned 20 patients Control group: planned 20 patients Endpoint (-s): Changes in muscle power, changes in 6-Minute Walk Distance (6MWD), changes in QoL changes in peak VO2 (bike exercise test)
Major study procedures:
Blood samples, vital parameters, questionnaires, echocardiography, lung function test, blood gas analysis, bike exercise test, 6-Minute Walk test, ECG, Chair rising test, power plate measurement, walk across test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | –This group will not do any specific training baseline and week 4 investigation will be done only |
| Exercise Group Galileo PAH | Active comparator | Device: Exercise Group Galileo PAHThe intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women age 18-90 years
- Signed informed consent
- Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
- Invasively confirmed PAH
- 6MWT ≥ 50 m
Key exclusion criteria (8 listed)
- any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma
- Rehabilitation or other training concept performed within 2 months before inclusion
- pregnancy
- acute thrombosis
- newly implanted Hip or Knee
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 |
|---|---|---|
| Exercise Group Galileo PAHThe intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks | Device | Exercise Group Galileo PAH |
Primary outcome
changes in 6-Minute Walk Distance (6MWD)
Time frame: baseline and week 4
3 secondary outcomes
Changes in Quality of life
Time frame: baseline and week 4
Changes in peak Vo2
Time frame: baseline and week 4
Changes in muscle power
Time frame: baseline and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Derived from this study: 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.
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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.
Felix Gerhardt, PhD principal investigator
Klinik III für Innere Medizin Uniklinik Köln
Stephan Rosenkranz, PhD principal investigator
Klinik III für Innere Medizin der Uniklinik Köln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group Galileo PAH in people with Pulmonary Artery Hypertension, 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 9 inclusion and 8 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 31 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in 6-Minute Walk Distance (6MWD) (time frame: baseline and week 4). 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 NCT01763112, 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 31 Mar 2015.