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Effect of Electromyostimulation on Bone
This study has been completed.
Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborators:
City of Erlangen
Behinderten- und Versehrten-Sportverband Bayern e.V.
Institute of Physical Education and Sports Sciences
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01296776
First received: February 14, 2011
Last updated: December 1, 2015
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Osteopenia Sarcopenia Falls | Other: wellness control group. Device: whole-body electromyostimulation | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females |
Further study details as provided by Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 ]as assessed by questionnaires
| Enrollment: | 78 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: whole-body electromyostimulation
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
|
Device: whole-body electromyostimulation
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.
Other Names:
|
|
Placebo Comparator: 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
|
Other: wellness control group.
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 Name: functional gymnastic, flexibility, relaxation.
|
Eligibility| Ages Eligible for Study: | 70 Years to 99 Years (Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- female gender
- 70 years and older
- osteopenia according to WHO
- BMI < 24 kg/m2
- living independently in the area of Erlangen-Nurnberg
Exclusion Criteria:
- 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,
- cancer,
- inflammable diseases,
- bleeding tendencies,
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01296776
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296776
Locations
| Germany | |
| Institute of Medical Physics, University of Erlangen-Nürnberg | |
| Erlangen, Germany, 91052 | |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
City of Erlangen
Behinderten- und Versehrten-Sportverband Bayern e.V.
Institute of Physical Education and Sports Sciences
Investigators
| Study Chair: | Willi A Kalender, PhD, MD | University of Erlangen-Nürnberg Medical School |
| Principal Investigator: | Wolfgang Kemmler, PhD | University of Erlangen-Nürnberg Medical School |
| Study Director: | Simon von Stengel, PhD | University of Erlangen-Nürnberg Medical School |
More Information
Additional Information:
Publications:
| Responsible Party: | Wolfgang Kemmler, Professor Dr., University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT01296776 History of Changes |
| Other Study ID Numbers: |
EMS-Bone-2011 EK_NO. 4184/2010 EMS_Bone_2011/2012 ( Other Grant/Funding Number: IMP_2011 ) |
| Study First Received: | February 14, 2011 |
| Last Updated: | December 1, 2015 |
Keywords provided by Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School:
|
exercise whole-body electromyostimulation bone mineral density |
falls physical fitness pain |
Additional relevant MeSH terms:
|
Sarcopenia Bone Diseases, Metabolic Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Atrophy Pathological Conditions, Anatomical Signs and Symptoms Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on July 21, 2017