AtrophyPhase 3NCT00292916
Effect of Whole Body Vibration on Bone and Fall Related Parameters
A Phase 3 study testing whole body vibration, resistance exercise and "wellness" in people with Atrophy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophy
- What is being tested?
- whole body vibration, resistance exercise and "wellness"
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jul 2007
- Phase
- Phase 3
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- community living elderly females >/=65 years
- live expectation > 2 years
Who cannot join
- secondary osteoporosis
- CVD-events including stroke
- participation in other studies
- medication and illness affecting bone metabolism within the last 2 years
- medication with impact on falls
- low physical performance (<50 Watt during ergometry)
- excessive alcohol-intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Body Vibration on Bone and Fall Related Parameters - the Erlangen Longitudinal Vibration Study (ELVIS)
The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.
- Conditions
- Atrophy
- Being tested
- whole body vibration, resistance exercise, "wellness"
- Keywords
- whole body vibration, exercise, elderly woman, Bone Mineral Density, falls, higher age
- Medical subject headings
- Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationBehavioural
resistance exerciseBehavioural
"wellness"Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD after 6, 12 and 18 months
strength
power
Secondary outcomes (2)
balance
bone markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AtrophyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biometrie and Medical Statistics, Netzwerk-Knochengesundheit, Siemens-Betriebskrankenkasse
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Willi A Kalender, PhD, Study chair, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292916
- Sponsor's protocol ID
- D-ER-OFZ-200501-Vib
- Status last verified
- May 2015
- First submitted
- 15 Feb 2006
- Last updated
- 28 May 2015
- Results posted
- No
Publications
Kemmler W, Engelke K, Baumann H, Beeskow C, von Stengel S, Weineck J, Kalender WA. Bone status in elite male runners. Eur J Appl Physiol. 2006 Jan;96(1):78-85. doi: 10.1007/s00421-005-0060-1. Epub 2005 Oct 26.
PubMed 16307280Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.
PubMed 16096715Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
PubMed 15746294Kemmler W, Weineck J, Kalender WA, Engelke K. The effect of habitual physical activity, non-athletic exercise, muscle strength, and VO2max on bone mineral density is rather low in early postmenopausal osteopenic women. J Musculoskelet Neuronal Interact. 2004 Sep;4(3):325-34.
PubMed 15615501Von Stengel S, Kemmler W, Bebenek M, Engelke K, Kalender WA. Effects of whole-body vibration training on different devices on bone mineral density. Med Sci Sports Exerc. 2011 Jun;43(6):1071-9. doi: 10.1249/MSS.0b013e318202f3d3.
PubMed 20980923
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration on Bone and Fall Related Parameters - the Erlangen Longitudinal Vibration Study (ELVIS)
- ClinicalTrials.gov ID
- NCT00292916
- Acronym / sponsor ID
- D-ER-OFZ-200501-Vib
- Conditions
- Atrophy
- Keywords
- whole body vibration, exercise, elderly woman, Bone Mineral Density, falls, higher age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Institute of Biometrie and Medical Statistics, Netzwerk-Knochengesundheit, Siemens-Betriebskrankenkasse
- Study start
- Jan 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Feb 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 effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- community living elderly females >/=65 years
- live expectation > 2 years
Key exclusion criteria (7 listed)
- secondary osteoporosis
- CVD-events including stroke
- participation in other studies
- medication and illness affecting bone metabolism within the last 2 years
- medication with impact on falls
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 |
|---|---|---|
| whole body vibration | Behavioural | – |
| resistance exercise | Behavioural | – |
| "wellness" | Behavioural | – |
Primary outcome
BMD after 6, 12 and 18 months
strength
power
2 secondary outcomes
balance
bone markers
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 16307280Kemmler W, Engelke K, Baumann H, Beeskow C, von Stengel S, Weineck J, Kalender WA. Bone status in elite male runners. Eur J Appl Physiol. 2006 Jan;96(1):78-85. doi: 10.1007/s00421-005-0060-1. Epub 2005 Oct 26.
- Background: PubMed 16096715Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.
- Background: PubMed 15746294Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
- Background: PubMed 15615501Kemmler W, Weineck J, Kalender WA, Engelke K. The effect of habitual physical activity, non-athletic exercise, muscle strength, and VO2max on bone mineral density is rather low in early postmenopausal osteopenic women. J Musculoskelet Neuronal Interact. 2004 Sep;4(3):325-34.
- Derived from this study: PubMed 20980923Von Stengel S, Kemmler W, Bebenek M, Engelke K, Kalender WA. Effects of whole-body vibration training on different devices on bone mineral density. Med Sci Sports Exerc. 2011 Jun;43(6):1071-9. doi: 10.1249/MSS.0b013e318202f3d3.
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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.
Willi A Kalender, PhD study chair
University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing whole body vibration, resistance exercise and "wellness" in people with Atrophy, run by University of Erlangen-Nürnberg Medical School 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 7 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: stopped early, as of the sponsor's last update on 28 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
BMD after 6, 12 and 18 months. The study lists 3 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 NCT00292916, which also lists 5 linked publications.
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 28 May 2015.