OsteopeniaPhase 3NCT01296776
Effect of Electromyostimulation on Bone
A Phase 3 study testing whole-body electromyostimulation in people with Osteopenia and Sarcopenia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via its acute and longitudinal effects on muscle mass and strength, the corresponding impact on bone density and falls in older adults has not been assessed yet. Read more about this study
- Who is it for?
- Ages 70 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Sarcopenia, Falls
- What is being tested?
- whole-body electromyostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2012
- 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 70 to 99 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- female gender
- 70 years and older
- osteopenia according to WHO
- BMI < 24 kg/m2
- living independently in the area of Erlangen-Nurnberg
Who cannot join
- medication or diseases affecting bone metabolism (including HRT)
- > 1 hour/week of exercise
- epilepsy, grave neurologic disturbances,
- cardiac pacemaker, grave circulatory disorders,
- abdomen/groin hernia,
- tuberculosis,
Show all 9Show fewer
- cancer,
- inflammable diseases,
- bleeding tendencies,
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, 91052
About this study
Official title: Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females
Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via its acute and longitudinal effects on muscle mass and strength, the corresponding impact on bone density and falls in older adults has not been assessed yet. The investigators hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and significantly reduce fall rate and ratio in a cohort of frail elderly women.
- Conditions
- Osteopenia, Sarcopenia, Falls
- Being tested
- wellness control group., whole-body electromyostimulation
- Keywords
- exercise, whole-body electromyostimulation, bone mineral density, falls, physical fitness, pain
- Medical subject headings
- Bone Diseases, Metabolic, Sarcopenia, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wellness control group.Other
Also called functional gymnastic, flexibility, relaxation.
Light physical exercise and relaxation program once a week in blocks of 10 weeks with breaks of 10 weeks between the blocks. The low-intensity, low-volume program was designed to avoid impact on our endpoints.
whole-body electromyostimulationDevice
Also called Electromusclestimulation, electrostimulation, Miha-bodytec
3 sessions of 18 min/14 (1,5 x week)days over 12 months. 10 low-intensity/low amplitude exercises with electromyostimulation equipment with 85 Hz with periods of 6 sec of current and 4 sec of rest.
| Study group | Role | What they receive |
|---|---|---|
| whole-body electromyostimulation | Active comparator | 20 min of whole-body electromyostimulation with sequences of 6 sec of current and 4 sec at 85 Hz performed during low-intensity/low amplitude movements. 3 sessions / 14 days for 12 months Receives: Device: whole-body electromyostimulation |
| wellness control group | Placebo comparator | Low intensity, low frequency exercise that focus on well being. 1 session/week for 10 weeks. 10 blocks of exercise with intermittent periods of 100 weeks of rest Receives: Other: wellness control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density at the lumbar spine and femoral neck region
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
Measured: baseline - after 12 months
Falls
Fall frequency and fall related injuries as assessed by the calendar method
Measured: throughout the 12 month study period
Secondary outcomes (2)
maximum strength (trunk and leg extension, grip strength)
Measured: baseline - after 12 months
Pain frequency and magnitude at various skeletal sites (including low back pain)
as assessed by questionnaires
Measured: baseline - after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- City of Erlangen, Behinderten- und Versehrten-Sportverband Bayern e.V., Institute of Physical Education and Sports Sciences
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Willi A Kalender, PhD, MD, Study chair, University of Erlangen-Nürnberg Medical SchoolWolfgang Kemmler, PhD, Principal investigator, University of Erlangen-Nürnberg Medical SchoolSimon von Stengel, PhD, Study director, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296776
- Sponsor's protocol ID
- EMS-Bone-2011
- Other IDs
- EK_NO. 4184/2010, EMS_Bone_2011/2012
- Status last verified
- Aug 2012
- First submitted
- 14 Feb 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kemmler W, Schliffka R, Mayhew JL, von Stengel S. Effects of whole-body electromyostimulation on resting metabolic rate, body composition, and maximum strength in postmenopausal women: the Training and ElectroStimulation Trial. J Strength Cond Res. 2010 Jul;24(7):1880-7. doi: 10.1519/JSC.0b013e3181ddaeee.
PubMed 20555279Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
PubMed 20101013von Stengel S, Kemmler W, Engelke K, Kalender WA. Effects of whole body vibration on bone mineral density and falls: results of the randomized controlled ELVIS study with postmenopausal women. Osteoporos Int. 2011 Jan;22(1):317-25. doi: 10.1007/s00198-010-1215-4. Epub 2010 Mar 20.
PubMed 20306017
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females
- ClinicalTrials.gov ID
- NCT01296776
- Acronym / sponsor ID
- EMS-Bone-2011
- Conditions
- Osteopenia, Sarcopenia, Falls
- Keywords
- exercise, whole-body electromyostimulation, bone mineral density, falls, physical fitness, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- City of Erlangen, Behinderten- und Versehrten-Sportverband Bayern e.V., Institute of Physical Education and Sports Sciences
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Feb 2011 (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.
Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via its acute and longitudinal effects on muscle mass and strength, the corresponding impact on bone density and falls in older adults has not been assessed yet. The investigators hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and significantly reduce fall rate and ratio in a cohort of frail elderly women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole-body electromyostimulation | Active comparator | Device: whole-body electromyostimulation20 min of whole-body electromyostimulation with sequences of 6 sec of current and 4 sec at 85 Hz performed during low-intensity/low amplitude movements. 3 sessions / 14 days for 12 months |
| wellness control group | Placebo comparator | Other: wellness control group.Low intensity, low frequency exercise that focus on well being. 1 session/week for 10 weeks. 10 blocks of exercise with intermittent periods of 100 weeks of rest |
Who may qualify
- Ages
- 70 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- female gender
- 70 years and older
- osteopenia according to WHO
- BMI < 24 kg/m2
- living independently in the area of Erlangen-Nurnberg
Key exclusion criteria (9 listed)
- medication or diseases affecting bone metabolism (including HRT)
- > 1 hour/week of exercise
- epilepsy, grave neurologic disturbances,
- cardiac pacemaker, grave circulatory disorders,
- abdomen/groin hernia,
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 |
|---|---|---|
| wellness control group.Also: functional gymnastic, flexibility, relaxation.Light physical exercise and relaxation program once a week in blocks of 10 weeks with breaks of 10 weeks between the blocks. The low-intensity, low-volume program was designed to avoid impact on our endpoints. | Other | wellness control group |
| whole-body electromyostimulationAlso: Electromusclestimulation, electrostimulation, Miha-bodytec3 sessions of 18 min/14 (1,5 x week)days over 12 months. 10 low-intensity/low amplitude exercises with electromyostimulation equipment with 85 Hz with periods of 6 sec of current and 4 sec of rest. | Device | whole-body electromyostimulation |
Primary outcome
Bone Mineral Density at the lumbar spine and femoral neck region
Time frame: baseline - after 12 months
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
Falls
Time frame: throughout the 12 month study period
Fall frequency and fall related injuries as assessed by the calendar method
2 secondary outcomes
maximum strength (trunk and leg extension, grip strength)
Time frame: baseline - after 12 months
Pain frequency and magnitude at various skeletal sites (including low back pain)
Time frame: baseline - after 12 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 2 Dec 2015.
- Background: PubMed 20555279Kemmler W, Schliffka R, Mayhew JL, von Stengel S. Effects of whole-body electromyostimulation on resting metabolic rate, body composition, and maximum strength in postmenopausal women: the Training and ElectroStimulation Trial. J Strength Cond Res. 2010 Jul;24(7):1880-7. doi: 10.1519/JSC.0b013e3181ddaeee.
- Background: PubMed 20101013Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
- Background: PubMed 20306017von Stengel S, Kemmler W, Engelke K, Kalender WA. Effects of whole body vibration on bone mineral density and falls: results of the randomized controlled ELVIS study with postmenopausal women. Osteoporos Int. 2011 Jan;22(1):317-25. doi: 10.1007/s00198-010-1215-4. Epub 2010 Mar 20.
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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, MD study chair
University of Erlangen-Nürnberg Medical School
Wolfgang Kemmler, PhD principal investigator
University of Erlangen-Nürnberg Medical School
Simon von Stengel, PhD study director
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 electromyostimulation in people with Osteopenia and Sarcopenia, 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 5 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: finished, as of the sponsor's last update on 2 Dec 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.
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 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?
Bone Mineral Density at the lumbar spine and femoral neck region (time frame: baseline - after 12 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 NCT01296776, which also lists 3 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 2 Dec 2015.