Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of LifeGALILEOHOMENCT02997683
3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH-HOME)
A study testing Body Vibration platform GALILEO and exercises at home on the floor in people with Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life, run by Klinikum der Universität Köln at 1 site in Germany.
Trial summary
In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and CTEPH patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline Parameters will… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life
- What is being tested?
- Body Vibration platform GALILEO and exercises at home on the floor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to Dec 2019
- 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)
- Persistend or inoperable CTEPH
- Invasively confirmed PAH
- 6MWT ≥ 50 - 450 m
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- Stable specific therapy for at least 6 weeks
- 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, associated with systemic scleroderma or CTEPH
- Rehabilitation or other training concept performed within 6 weeks before inclusion
- pregnancy
- acute thrombosis
- newly implanted Hip or Knee
- recent bone fracture
Show all 9Show fewer
- Disability to confirm consent
- NYHA/WHO-FC IV
- 6MWD below 50 or above 450 m
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Spezialambulanz für pulmonale Hypertonie Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
Felix Gerhardt, PhD, +49221478 ext. 89413, felix.gerhardt@uk-koeln.de
Felix Gerhardt, PhD
About this study
Official title: 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) in an Extended 3-month Home Based Training. Background and Rationale for the Proposal: Capacity and the Ability to Exercise, in Patients With PAH is Limited. Primary Scientific Question Addressed:Changes in Muscle Power, Changes in 6-Minute Walk Distance (6MWD) and Changes in QoL Are to be Evaluated.
In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and CTEPH patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline Parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not perfoming the exercises on the wbv-device but on the floor.
Read the detailed description
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training accoridng to protocol
Day 2: Telephone Visit
Day 5: Telephone Visit
Day 7: Telephone Visit
Day 10: Telephone Visit
Day 13: Telephone Visit
Day 20: Telephone Visit
Day 27: Telephone Visit
Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training
Month 2:
Week 5, Day 34:
Week 6, Day 41:
Week 7, Day 48:
Week 8, Day 55:
Month 3:
Week 9, Day 62:
Week 10, Day 69:
Week 11, Day 76:
Week 12, Day 83: Final Visit
- Being tested
- Body Vibration platform GALILEO, exercises at home on the floor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Vibration platform GALILEODevice
3 month home based training on whole Body Vibration platform GALILEO
exercises at home on the floorOther
exercises at home on the floor
| Study group | Role | What they receive |
|---|---|---|
| 3-month home based training on whole body vibration platform | Experimental | This Group will receive a training device to perform their given exercises on Receives: Device: Body Vibration platform GALILEO |
| 3-month home based training on floor | Placebo comparator | This Group will perform their given exercises at home on the floor Receives: Other: exercises at home on the floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 6 Minute Walking distance
Measured: 3 months
Changes in 6 Minute Walking distance
Measured: 4 weeks interm analysis
Secondary outcomes (4)
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
Measured: 3 months
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
Measured: 4 weeks
Changes in Quality of Life
Measured: 3 months
Changes in Quality of Life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Jan 2018
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of LifeStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT02997683
- Sponsor's protocol ID
- 002
- Acronym
- GALILEOHOME
- Status last verified
- Apr 2019
- First submitted
- 16 Dec 2016
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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) in an Extended 3-month Home Based Training. Background and Rationale for the Proposal: Capacity and the Ability to Exercise, in Patients With PAH is Limited. Primary Scientific Question Addressed:Changes in Muscle Power, Changes in 6-Minute Walk Distance (6MWD) and Changes in QoL Are to be Evaluated.
- ClinicalTrials.gov ID
- NCT02997683
- Acronym / sponsor ID
- GALILEOHOME / 002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Klinikum der Universität KölnUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Dec 2016 (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.
In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and CTEPH patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline Parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not perfoming the exercises on the wbv-device but on the floor.
Detailed description
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training accoridng to protocol
Day 2: Telephone Visit
Day 5: Telephone Visit
Day 7: Telephone Visit
Day 10: Telephone Visit
Day 13: Telephone Visit
Day 20: Telephone Visit
Day 27: Telephone Visit
Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training
Month 2:
Week 5, Day 34:
Week 6, Day 41:
Week 7, Day 48:
Week 8, Day 55:
Month 3:
Week 9, Day 62:
Week 10, Day 69:
Week 11, Day 76:
Week 12, Day 83: Final Visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-month home based training on whole body vibration platform | Experimental | Device: Body Vibration platform GALILEOThis Group will receive a training device to perform their given exercises on |
| 3-month home based training on floor | Placebo comparator | Other: exercises at home on the floorThis Group will perform their given exercises at home on the floor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women age 18-90 years
- Signed informed consent
- Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
- Persistend or inoperable CTEPH
- Invasively confirmed PAH
Key exclusion criteria (9 listed)
- any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH
- Rehabilitation or other training concept performed within 6 weeks 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 |
|---|---|---|
| Body Vibration platform GALILEO3 month home based training on whole Body Vibration platform GALILEO | Device | 3-month home based training on whole body vibration platform |
| exercises at home on the floorexercises at home on the floor | Other | 3-month home based training on floor |
Primary outcome
Changes in 6 Minute Walking distance
Time frame: 3 months
Changes in 6 Minute Walking distance
Time frame: 4 weeks interm analysis
4 secondary outcomes
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
Time frame: 3 months
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
Time frame: 4 weeks
Changes in Quality of Life
Time frame: 3 months
Changes in Quality of Life
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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?
A study testing Body Vibration platform GALILEO and exercises at home on the floor in people with Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life, 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 10 inclusion and 9 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 26 Apr 2019. 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?
Contact Felix Gerhardt, MD (+4947889413, 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?
Changes in 6 Minute Walking distance (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2019.