Cystic FibrosisNCT00388466
Whole Body Vibration - a New Therapeutic Approach to Improve Muscle Function in CF
A study testing GALILEO in people with Cystic Fibrosis, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- GALILEO
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2005to Aug 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Cystic Fibrosis
- age older than 18 years
Who cannot join
- hypersplenic syndrome
- acute arthritis or osteomyelitis
Trial locations and contacts
1 site in 1 country.
Germany1 site
CF Center Cologne, University Children's Hospital
Cologne, 50924
About this study
Official title: Cystic Fibrosis: Improvement of Muscle Force and Function by Whole Body Vibration Exercise
The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients.
Read the detailed description
Cystic Fibrosis (CF) is the most common chronic hereditary disease in Caucasians. Due to improved therapy and better understanding of the disease, life expectancy has risen to an average of 38 years and is continuing to rise. With the increased life-expectancy it becomes even more important to maintain functional activity as part of quality of life. Mechanical stimulation in form of whole body vibration (WBV) is a new type of exercise currently tested in sports, geriatrics and rehabilitation. It has recently been found to be a safe and efficient method to activate muscular activity via stretch reflexes leading to improvement of muscular performance, body balance and physical functioning.
10 patients of the CF Center Cologne, Germany, took part in the Galileo study. They were provided by the vibrating platform (Galileo 2000)for whole body vibration training at home. The patients were standing in an upright position receiving vertical vibration of frequencies between 20-25 Hz. This vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity. The training schedule consisted of three 3-minute sessions twice a day 5 days per week for 3 months.
Every 4 weeks the patients were seen for assessment of muscle function to evaluate the effects of this new intervention.
- Conditions
- Cystic Fibrosis
- Being tested
- GALILEO
- Keywords
- whole body vibration, muscle function, cystic fibrosis, mechanography, chair-rising-test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GALILEODevice
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle force at the beginning of the study and after 3 months
muscle power at the beginning of the study and after 3 months
Secondary outcomes (1)
pulmonary function testing at the beginning of the study and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
- Study startJun 2005
- Study completionAug 2006
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 Cystic FibrosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Eckhard Schoenau, Prof., Study chair, University Children´s Hospital Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388466
- Sponsor's protocol ID
- 05-005
- Status last verified
- Oct 2006
- First submitted
- 13 Oct 2006
- Last updated
- 16 Oct 2006
- Results posted
- No
Publications
Fricke O, Weidler J, Tutlewski B, Schoenau E. Mechanography--a new device for the assessment of muscle function in pediatrics. Pediatr Res. 2006 Jan;59(1):46-9. doi: 10.1203/01.pdr.0000191580.07644.1c. Epub 2005 Dec 2.
PubMed 16327004
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Fibrosis: Improvement of Muscle Force and Function by Whole Body Vibration Exercise
- ClinicalTrials.gov ID
- NCT00388466
- Acronym / sponsor ID
- 05-005
- Conditions
- Cystic Fibrosis
- Keywords
- whole body vibration, muscle function, cystic fibrosis, mechanography, chair-rising-test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Aug 2006
- First posted
- 16 Oct 2006 (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.
The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients.
Detailed description
Cystic Fibrosis (CF) is the most common chronic hereditary disease in Caucasians. Due to improved therapy and better understanding of the disease, life expectancy has risen to an average of 38 years and is continuing to rise. With the increased life-expectancy it becomes even more important to maintain functional activity as part of quality of life. Mechanical stimulation in form of whole body vibration (WBV) is a new type of exercise currently tested in sports, geriatrics and rehabilitation. It has recently been found to be a safe and efficient method to activate muscular activity via stretch reflexes leading to improvement of muscular performance, body balance and physical functioning.
10 patients of the CF Center Cologne, Germany, took part in the Galileo study. They were provided by the vibrating platform (Galileo 2000)for whole body vibration training at home. The patients were standing in an upright position receiving vertical vibration of frequencies between 20-25 Hz. This vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity. The training schedule consisted of three 3-minute sessions twice a day 5 days per week for 3 months.
Every 4 weeks the patients were seen for assessment of muscle function to evaluate the effects of this new intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Cystic Fibrosis
- age older than 18 years
Key exclusion criteria (2 listed)
- hypersplenic syndrome
- acute arthritis or osteomyelitis
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 |
|---|---|---|
| GALILEO | Device | – |
Primary outcome
muscle force at the beginning of the study and after 3 months
muscle power at the beginning of the study and after 3 months
1 secondary outcome
pulmonary function testing at the beginning of the study and after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2006.
- Background: PubMed 16327004Fricke O, Weidler J, Tutlewski B, Schoenau E. Mechanography--a new device for the assessment of muscle function in pediatrics. Pediatr Res. 2006 Jan;59(1):46-9. doi: 10.1203/01.pdr.0000191580.07644.1c. Epub 2005 Dec 2.
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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.
Eckhard Schoenau, Prof. study chair
University Children´s Hospital Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GALILEO in people with Cystic Fibrosis, run by University of Cologne 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 2 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: finished, as of the sponsor's last update on 16 Oct 2006. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
muscle force at the beginning of the study and after 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?
On the ClinicalTrials.gov record for NCT00388466, 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 16 Oct 2006.